HT Staff

A cooler packed with blood

products attached to a

S900-model drone.

Photo courtesy of

Johns Hopkins Medicine

A proof-of-concept study suggests that large bags of blood products can maintain temperature and cellular integrity when transported by drones.

Researchers say these findings, published in Transfusion, add to evidence that remotely piloted drones are an effective, safe, and timely way to quickly get blood products to remote accident or natural catastrophe sites, or other time-sensitive destinations.

“For rural areas that lack access to nearby clinics, or that may lack the infrastructure for collecting blood products or transporting them on their own, drones can provide that access,” said study author Timothy Amukele, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Drones also can help in urban centers to improve distribution of blood products and the quality of care, he added.

Dr Amukele and his colleagues previously studied the impact of drone transportation on the chemical, hematological, and microbial makeup of drone-flown blood samples and found that none were negatively affected.

Study design, methods

In the new study, the team examined the effects of drone transportation on larger amounts of blood products used for transfusion, which have significantly more complex handling, transport, and storage requirements compared to blood samples for laboratory testing.

The researchers purchased 6 units of red blood cells (RBCs), 6 units of platelets, and 6 units of unthawed plasma from the American Red Cross. They then packed the units into a 5-quart cooler, 2 to 3 units at a time, in keeping with weight restrictions for the transport drone.

The cooler was then attached to a commercial S900-model drone. This particular drone model comes equipped with a camera mount, which the team removed and replaced with the cooler.

For each test, the drone was flown by remote control a distance of approximately 13 to 20 kilometers (8 to 12 miles) while 100 meters (328 feet) above ground. This flight took up to 26.5 minutes.

The researchers designed the test to maintain temperature for the RBCs, platelets, and plasma units. They used wet ice, pre-calibrated thermal packs, and dry ice for each type of blood product, respectively.

Temperature monitoring was constant, keeping with transport and storage requirements for blood components.

The team conducted the tests in an unpopulated area, and a certified, ground-based pilot flew the drone.

Following flight, all units were transported to The Johns Hopkins Hospital and compared to blood products that had not taken a drone trip.

Results

Dr Amukele and his colleagues checked the RBCs for signs of hemolysis. They checked the platelets for changes in pH, the number of platelets, and mean platelet volume. And they checked the plasma units for evidence of air bubbles, which would indicate thawing.

The researchers found no evidence of hemolysis in the control RBCs or the RBCs that had taken the drone flight.

There was no significant difference in pH, platelet counts, or mean platelet volume between control and drone-flown platelets.

And there was no apparent change in the size or shape of air bubbles in the plasma units before and after drone flight.

However, the researchers did find that, for all flown units, there was a decrease in temperature of between 1.5°C and 4°C during the course of the flight. They said the cause of this decrease was probably the ambient temperature in the case of the platelet units, the wet ice in the case of the RBCs, and the dry ice in the case of the plasma.

The team also found an up to 2°C difference between individual flights for both the RBCs and the plasma units. They said this difference is likely due to the differences in the amounts of wet and dry ice placed in the cooler.

The researchers are planning further and larger studies in the US and overseas, and they hope to test methods of active cooling, such as programming a cooler to maintain a specific temperature.

“My vision is that, in the future, when a first responder arrives to the scene of an accident, he or she can test the victim’s blood type right on the spot and send for a drone to bring the correct blood product,” Dr Amukele said.

Funding for this study was provided by Peter Kovler of the Blum-Kovler Foundation.

A cooler packed with blood

products attached to a

S900-model drone.

Photo courtesy of

Johns Hopkins Medicine

A proof-of-concept study suggests that large bags of blood products can maintain temperature and cellular integrity when transported by drones.

Researchers say these findings, published in Transfusion, add to evidence that remotely piloted drones are an effective, safe, and timely way to quickly get blood products to remote accident or natural catastrophe sites, or other time-sensitive destinations.

“For rural areas that lack access to nearby clinics, or that may lack the infrastructure for collecting blood products or transporting them on their own, drones can provide that access,” said study author Timothy Amukele, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Drones also can help in urban centers to improve distribution of blood products and the quality of care, he added.

Dr Amukele and his colleagues previously studied the impact of drone transportation on the chemical, hematological, and microbial makeup of drone-flown blood samples and found that none were negatively affected.

Study design, methods

In the new study, the team examined the effects of drone transportation on larger amounts of blood products used for transfusion, which have significantly more complex handling, transport, and storage requirements compared to blood samples for laboratory testing.

The researchers purchased 6 units of red blood cells (RBCs), 6 units of platelets, and 6 units of unthawed plasma from the American Red Cross. They then packed the units into a 5-quart cooler, 2 to 3 units at a time, in keeping with weight restrictions for the transport drone.

The cooler was then attached to a commercial S900-model drone. This particular drone model comes equipped with a camera mount, which the team removed and replaced with the cooler.

For each test, the drone was flown by remote control a distance of approximately 13 to 20 kilometers (8 to 12 miles) while 100 meters (328 feet) above ground. This flight took up to 26.5 minutes.

The researchers designed the test to maintain temperature for the RBCs, platelets, and plasma units. They used wet ice, pre-calibrated thermal packs, and dry ice for each type of blood product, respectively.

Temperature monitoring was constant, keeping with transport and storage requirements for blood components.

The team conducted the tests in an unpopulated area, and a certified, ground-based pilot flew the drone.

Following flight, all units were transported to The Johns Hopkins Hospital and compared to blood products that had not taken a drone trip.

Results

Dr Amukele and his colleagues checked the RBCs for signs of hemolysis. They checked the platelets for changes in pH, the number of platelets, and mean platelet volume. And they checked the plasma units for evidence of air bubbles, which would indicate thawing.

The researchers found no evidence of hemolysis in the control RBCs or the RBCs that had taken the drone flight.

There was no significant difference in pH, platelet counts, or mean platelet volume between control and drone-flown platelets.

And there was no apparent change in the size or shape of air bubbles in the plasma units before and after drone flight.

However, the researchers did find that, for all flown units, there was a decrease in temperature of between 1.5°C and 4°C during the course of the flight. They said the cause of this decrease was probably the ambient temperature in the case of the platelet units, the wet ice in the case of the RBCs, and the dry ice in the case of the plasma.

The team also found an up to 2°C difference between individual flights for both the RBCs and the plasma units. They said this difference is likely due to the differences in the amounts of wet and dry ice placed in the cooler.

The researchers are planning further and larger studies in the US and overseas, and they hope to test methods of active cooling, such as programming a cooler to maintain a specific temperature.

“My vision is that, in the future, when a first responder arrives to the scene of an accident, he or she can test the victim’s blood type right on the spot and send for a drone to bring the correct blood product,” Dr Amukele said.

Funding for this study was provided by Peter Kovler of the Blum-Kovler Foundation.

A cooler packed with blood

products attached to a

S900-model drone.

Photo courtesy of

Johns Hopkins Medicine

A proof-of-concept study suggests that large bags of blood products can maintain temperature and cellular integrity when transported by drones.

Researchers say these findings, published in Transfusion, add to evidence that remotely piloted drones are an effective, safe, and timely way to quickly get blood products to remote accident or natural catastrophe sites, or other time-sensitive destinations.

“For rural areas that lack access to nearby clinics, or that may lack the infrastructure for collecting blood products or transporting them on their own, drones can provide that access,” said study author Timothy Amukele, MD, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Drones also can help in urban centers to improve distribution of blood products and the quality of care, he added.

Dr Amukele and his colleagues previously studied the impact of drone transportation on the chemical, hematological, and microbial makeup of drone-flown blood samples and found that none were negatively affected.

Study design, methods

In the new study, the team examined the effects of drone transportation on larger amounts of blood products used for transfusion, which have significantly more complex handling, transport, and storage requirements compared to blood samples for laboratory testing.

The researchers purchased 6 units of red blood cells (RBCs), 6 units of platelets, and 6 units of unthawed plasma from the American Red Cross. They then packed the units into a 5-quart cooler, 2 to 3 units at a time, in keeping with weight restrictions for the transport drone.

The cooler was then attached to a commercial S900-model drone. This particular drone model comes equipped with a camera mount, which the team removed and replaced with the cooler.

For each test, the drone was flown by remote control a distance of approximately 13 to 20 kilometers (8 to 12 miles) while 100 meters (328 feet) above ground. This flight took up to 26.5 minutes.

The researchers designed the test to maintain temperature for the RBCs, platelets, and plasma units. They used wet ice, pre-calibrated thermal packs, and dry ice for each type of blood product, respectively.

Temperature monitoring was constant, keeping with transport and storage requirements for blood components.

The team conducted the tests in an unpopulated area, and a certified, ground-based pilot flew the drone.

Following flight, all units were transported to The Johns Hopkins Hospital and compared to blood products that had not taken a drone trip.

Results

Dr Amukele and his colleagues checked the RBCs for signs of hemolysis. They checked the platelets for changes in pH, the number of platelets, and mean platelet volume. And they checked the plasma units for evidence of air bubbles, which would indicate thawing.

The researchers found no evidence of hemolysis in the control RBCs or the RBCs that had taken the drone flight.

There was no significant difference in pH, platelet counts, or mean platelet volume between control and drone-flown platelets.

And there was no apparent change in the size or shape of air bubbles in the plasma units before and after drone flight.

However, the researchers did find that, for all flown units, there was a decrease in temperature of between 1.5°C and 4°C during the course of the flight. They said the cause of this decrease was probably the ambient temperature in the case of the platelet units, the wet ice in the case of the RBCs, and the dry ice in the case of the plasma.

The team also found an up to 2°C difference between individual flights for both the RBCs and the plasma units. They said this difference is likely due to the differences in the amounts of wet and dry ice placed in the cooler.

The researchers are planning further and larger studies in the US and overseas, and they hope to test methods of active cooling, such as programming a cooler to maintain a specific temperature.

“My vision is that, in the future, when a first responder arrives to the scene of an accident, he or she can test the victim’s blood type right on the spot and send for a drone to bring the correct blood product,” Dr Amukele said.

Funding for this study was provided by Peter Kovler of the Blum-Kovler Foundation.

First month’s supply of venetoclax

(US version, Venclexta)

Photo courtesy of Abbvie

The European Commission (EC) has granted conditional marketing authorization for the oral BCL-2 inhibitor venetoclax (Venclyxto™) to treat certain patients with chronic lymphocytic leukemia (CLL).

The drug is now approved as monotherapy to treat adults with CLL who have 17p deletion or TP53 mutation and are unsuitable for or have failed a B-cell receptor pathway inhibitor.

Venetoclax is also approved as monotherapy to treat CLL in the absence of 17p deletion or TP53 mutation in adults who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

Venetoclax is the first BCL-2 inhibitor authorized for use in Europe.

Conditional marketing authorization represents an expedited path for approval. The EC grants conditional marketing authorization to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

Conditional marketing authorization is granted before pivotal registration studies of a product are completed, but the company developing the product is required to complete post-marketing studies showing that the product provides a clinical benefit.

Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. The drug is jointly commercialized by the companies in the US and by AbbVie outside of the US.

Phase 2 trials

Venetoclax has produced high objective response rates (ORR) in two phase 2 trials of CLL patients.

In one of these trials, researchers tested venetoclax in 107 patients with previously treated CLL and 17p deletion. The results were published in The Lancet Oncology in June.

The ORR in this trial was 79%. At the time of analysis, the median duration of response had not been reached. The same was true for progression-free survival and overall survival.

The progression-free survival estimate for 12 months was 72%, and the overall survival estimate was 87%.

The incidence of treatment-emergent adverse events was 96%, and the incidence of serious adverse events was 55%.

Grade 3 laboratory tumor lysis syndrome (TLS) was reported in 5 patients. Three of these patients continued on venetoclax, but 2 patients required a dose interruption of 1 day each.

In the second trial, researchers tested venetoclax in 64 patients with CLL who had failed treatment with ibrutinib and/or idelalisib. Results from this trial were presented at the 2016 ASH Annual Meeting.

The ORR was 67%. At 11.8 months of follow-up, the median duration of response, progression-free survival, and overall survival had not been reached. The estimated 12-month progression-free survival was 80%.

The incidence of adverse events was 100%, and the incidence of serious adverse events was 53%. No clinical TLS was observed, but 1 patient met Howard criteria for laboratory TLS.

First month’s supply of venetoclax

(US version, Venclexta)

Photo courtesy of Abbvie

The European Commission (EC) has granted conditional marketing authorization for the oral BCL-2 inhibitor venetoclax (Venclyxto™) to treat certain patients with chronic lymphocytic leukemia (CLL).

The drug is now approved as monotherapy to treat adults with CLL who have 17p deletion or TP53 mutation and are unsuitable for or have failed a B-cell receptor pathway inhibitor.

Venetoclax is also approved as monotherapy to treat CLL in the absence of 17p deletion or TP53 mutation in adults who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

Venetoclax is the first BCL-2 inhibitor authorized for use in Europe.

Conditional marketing authorization represents an expedited path for approval. The EC grants conditional marketing authorization to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

Conditional marketing authorization is granted before pivotal registration studies of a product are completed, but the company developing the product is required to complete post-marketing studies showing that the product provides a clinical benefit.

Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. The drug is jointly commercialized by the companies in the US and by AbbVie outside of the US.

Phase 2 trials

Venetoclax has produced high objective response rates (ORR) in two phase 2 trials of CLL patients.

In one of these trials, researchers tested venetoclax in 107 patients with previously treated CLL and 17p deletion. The results were published in The Lancet Oncology in June.

The ORR in this trial was 79%. At the time of analysis, the median duration of response had not been reached. The same was true for progression-free survival and overall survival.

The progression-free survival estimate for 12 months was 72%, and the overall survival estimate was 87%.

The incidence of treatment-emergent adverse events was 96%, and the incidence of serious adverse events was 55%.

Grade 3 laboratory tumor lysis syndrome (TLS) was reported in 5 patients. Three of these patients continued on venetoclax, but 2 patients required a dose interruption of 1 day each.

In the second trial, researchers tested venetoclax in 64 patients with CLL who had failed treatment with ibrutinib and/or idelalisib. Results from this trial were presented at the 2016 ASH Annual Meeting.

The ORR was 67%. At 11.8 months of follow-up, the median duration of response, progression-free survival, and overall survival had not been reached. The estimated 12-month progression-free survival was 80%.

The incidence of adverse events was 100%, and the incidence of serious adverse events was 53%. No clinical TLS was observed, but 1 patient met Howard criteria for laboratory TLS.

First month’s supply of venetoclax

(US version, Venclexta)

Photo courtesy of Abbvie

The European Commission (EC) has granted conditional marketing authorization for the oral BCL-2 inhibitor venetoclax (Venclyxto™) to treat certain patients with chronic lymphocytic leukemia (CLL).

The drug is now approved as monotherapy to treat adults with CLL who have 17p deletion or TP53 mutation and are unsuitable for or have failed a B-cell receptor pathway inhibitor.

Venetoclax is also approved as monotherapy to treat CLL in the absence of 17p deletion or TP53 mutation in adults who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

Venetoclax is the first BCL-2 inhibitor authorized for use in Europe.

Conditional marketing authorization represents an expedited path for approval. The EC grants conditional marketing authorization to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

Conditional marketing authorization is granted before pivotal registration studies of a product are completed, but the company developing the product is required to complete post-marketing studies showing that the product provides a clinical benefit.

Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. The drug is jointly commercialized by the companies in the US and by AbbVie outside of the US.

Phase 2 trials

Venetoclax has produced high objective response rates (ORR) in two phase 2 trials of CLL patients.

In one of these trials, researchers tested venetoclax in 107 patients with previously treated CLL and 17p deletion. The results were published in The Lancet Oncology in June.

The ORR in this trial was 79%. At the time of analysis, the median duration of response had not been reached. The same was true for progression-free survival and overall survival.

The progression-free survival estimate for 12 months was 72%, and the overall survival estimate was 87%.

The incidence of treatment-emergent adverse events was 96%, and the incidence of serious adverse events was 55%.

Grade 3 laboratory tumor lysis syndrome (TLS) was reported in 5 patients. Three of these patients continued on venetoclax, but 2 patients required a dose interruption of 1 day each.

In the second trial, researchers tested venetoclax in 64 patients with CLL who had failed treatment with ibrutinib and/or idelalisib. Results from this trial were presented at the 2016 ASH Annual Meeting.

The ORR was 67%. At 11.8 months of follow-up, the median duration of response, progression-free survival, and overall survival had not been reached. The estimated 12-month progression-free survival was 80%.

The incidence of adverse events was 100%, and the incidence of serious adverse events was 53%. No clinical TLS was observed, but 1 patient met Howard criteria for laboratory TLS.

Skeletal remains of an

individual from Velia, Italy

Photo courtesy of Luca

Bandioli, Pigorini Museum

An analysis of 2000-year-old human remains from several regions across the Italian peninsula has confirmed the presence of Plasmodium falciparum malaria during the Roman Empire, according to researchers.

The team found mitochondrial genomic evidence of P falciparum malaria, coaxed from the teeth of bodies buried in 3 Italian cemeteries, dating back to the Imperial period.

The researchers said these finding provide a key reference point for when and where the malaria parasite existed in humans, as well as more information about the evolution of human disease.

The team reported these findings in Current Biology.

“There is extensive written evidence describing fevers that sound like malaria in ancient Greece and Rome, but the specific malaria species responsible is unknown,” said study author Stephanie Marciniak, PhD, of Pennsylvania State University in University Park.

“Our data confirm that the species was likely Plasmodium falciparum and that it affected people in different ecological and cultural environments. These results open up new questions to explore, particularly how widespread this parasite was and what burden it placed upon communities in Imperial Roman Italy.”

Dr Marciniak and her colleagues sampled teeth taken from 58 adults interred at 3 Imperial period Italian cemeteries: Isola Sacra, Velia, and Vagnari.

Located on the coast, Velia and Isola Sacra were known as important port cities and trading centers. Vagnari is located further inland and believed to be the burial site of laborers who would have worked on a Roman rural estate.

The researchers mined tiny DNA fragments from dental pulp. They were able to extract, purify, and enrich specifically for the Plasmodium species known to infect humans.

The team noted that usable DNA is challenging to extract because the parasites primarily dwell within the bloodstream and organs, which decompose and break down over time—in this instance, over the course of 2 millennia.

However, the researchers recovered more than half of the P falciparum mitochondrial genome from 2 individuals from Velia and Vagnari.

Skeletal remains of an

individual from Velia, Italy

Photo courtesy of Luca

Bandioli, Pigorini Museum

An analysis of 2000-year-old human remains from several regions across the Italian peninsula has confirmed the presence of Plasmodium falciparum malaria during the Roman Empire, according to researchers.

The team found mitochondrial genomic evidence of P falciparum malaria, coaxed from the teeth of bodies buried in 3 Italian cemeteries, dating back to the Imperial period.

The researchers said these finding provide a key reference point for when and where the malaria parasite existed in humans, as well as more information about the evolution of human disease.

The team reported these findings in Current Biology.

“There is extensive written evidence describing fevers that sound like malaria in ancient Greece and Rome, but the specific malaria species responsible is unknown,” said study author Stephanie Marciniak, PhD, of Pennsylvania State University in University Park.

“Our data confirm that the species was likely Plasmodium falciparum and that it affected people in different ecological and cultural environments. These results open up new questions to explore, particularly how widespread this parasite was and what burden it placed upon communities in Imperial Roman Italy.”

Dr Marciniak and her colleagues sampled teeth taken from 58 adults interred at 3 Imperial period Italian cemeteries: Isola Sacra, Velia, and Vagnari.

Located on the coast, Velia and Isola Sacra were known as important port cities and trading centers. Vagnari is located further inland and believed to be the burial site of laborers who would have worked on a Roman rural estate.

The researchers mined tiny DNA fragments from dental pulp. They were able to extract, purify, and enrich specifically for the Plasmodium species known to infect humans.

The team noted that usable DNA is challenging to extract because the parasites primarily dwell within the bloodstream and organs, which decompose and break down over time—in this instance, over the course of 2 millennia.

However, the researchers recovered more than half of the P falciparum mitochondrial genome from 2 individuals from Velia and Vagnari.

Skeletal remains of an

individual from Velia, Italy

Photo courtesy of Luca

Bandioli, Pigorini Museum

An analysis of 2000-year-old human remains from several regions across the Italian peninsula has confirmed the presence of Plasmodium falciparum malaria during the Roman Empire, according to researchers.

The team found mitochondrial genomic evidence of P falciparum malaria, coaxed from the teeth of bodies buried in 3 Italian cemeteries, dating back to the Imperial period.

The researchers said these finding provide a key reference point for when and where the malaria parasite existed in humans, as well as more information about the evolution of human disease.

The team reported these findings in Current Biology.

“There is extensive written evidence describing fevers that sound like malaria in ancient Greece and Rome, but the specific malaria species responsible is unknown,” said study author Stephanie Marciniak, PhD, of Pennsylvania State University in University Park.

“Our data confirm that the species was likely Plasmodium falciparum and that it affected people in different ecological and cultural environments. These results open up new questions to explore, particularly how widespread this parasite was and what burden it placed upon communities in Imperial Roman Italy.”

Dr Marciniak and her colleagues sampled teeth taken from 58 adults interred at 3 Imperial period Italian cemeteries: Isola Sacra, Velia, and Vagnari.

Located on the coast, Velia and Isola Sacra were known as important port cities and trading centers. Vagnari is located further inland and believed to be the burial site of laborers who would have worked on a Roman rural estate.

The researchers mined tiny DNA fragments from dental pulp. They were able to extract, purify, and enrich specifically for the Plasmodium species known to infect humans.

The team noted that usable DNA is challenging to extract because the parasites primarily dwell within the bloodstream and organs, which decompose and break down over time—in this instance, over the course of 2 millennia.

However, the researchers recovered more than half of the P falciparum mitochondrial genome from 2 individuals from Velia and Vagnari.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

Researchers have estimated the global incidence of 32 cancer types and deaths related to these malignancies in 2015.

The group’s data, published in JAMA Oncology, suggest there were 17.5 million cancer cases and 8.7 million cancer deaths last year.

There were 78,000 cases of Hodgkin lymphoma and 24,000 deaths from the disease, as well as 666,000 cases of non-Hodgkin lymphoma (NHL) and 231,000 NHL deaths.

There were 154,000 cases of multiple myeloma and 101,000 deaths from the disease.

And there were 606,000 cases of leukemia, with 353,000 leukemia deaths. This included 161,000 cases of acute lymphoid leukemia (110,000 deaths), 191,000 cases of chronic lymphoid leukemia (61,000 deaths), 190,000 cases of acute myeloid leukemia (147,000 deaths), and 64,000 cases of chronic myeloid leukemia (35,000 deaths).

The data also show that, between 2005 and 2015, cancer cases increased by 33%, mostly due to population aging and growth, plus changes in age-specific cancer rates.

Globally, the odds of developing cancer during a lifetime were 1 in 3 for men and 1 in 4 for women in 2015.

Prostate cancer was the most common cancer in men (1.6 million cases), although tracheal, bronchus, and lung cancer was the leading cause of cancer deaths for men.

Breast cancer was the most common cancer for women (2.4 million cases) and the leading cause of cancer deaths in women.

The most common childhood cancers were leukemia, “other neoplasms,” NHL, and brain and nervous system cancers.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

Researchers have estimated the global incidence of 32 cancer types and deaths related to these malignancies in 2015.

The group’s data, published in JAMA Oncology, suggest there were 17.5 million cancer cases and 8.7 million cancer deaths last year.

There were 78,000 cases of Hodgkin lymphoma and 24,000 deaths from the disease, as well as 666,000 cases of non-Hodgkin lymphoma (NHL) and 231,000 NHL deaths.

There were 154,000 cases of multiple myeloma and 101,000 deaths from the disease.

And there were 606,000 cases of leukemia, with 353,000 leukemia deaths. This included 161,000 cases of acute lymphoid leukemia (110,000 deaths), 191,000 cases of chronic lymphoid leukemia (61,000 deaths), 190,000 cases of acute myeloid leukemia (147,000 deaths), and 64,000 cases of chronic myeloid leukemia (35,000 deaths).

The data also show that, between 2005 and 2015, cancer cases increased by 33%, mostly due to population aging and growth, plus changes in age-specific cancer rates.

Globally, the odds of developing cancer during a lifetime were 1 in 3 for men and 1 in 4 for women in 2015.

Prostate cancer was the most common cancer in men (1.6 million cases), although tracheal, bronchus, and lung cancer was the leading cause of cancer deaths for men.

Breast cancer was the most common cancer for women (2.4 million cases) and the leading cause of cancer deaths in women.

The most common childhood cancers were leukemia, “other neoplasms,” NHL, and brain and nervous system cancers.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

Researchers have estimated the global incidence of 32 cancer types and deaths related to these malignancies in 2015.

The group’s data, published in JAMA Oncology, suggest there were 17.5 million cancer cases and 8.7 million cancer deaths last year.

There were 78,000 cases of Hodgkin lymphoma and 24,000 deaths from the disease, as well as 666,000 cases of non-Hodgkin lymphoma (NHL) and 231,000 NHL deaths.

There were 154,000 cases of multiple myeloma and 101,000 deaths from the disease.

And there were 606,000 cases of leukemia, with 353,000 leukemia deaths. This included 161,000 cases of acute lymphoid leukemia (110,000 deaths), 191,000 cases of chronic lymphoid leukemia (61,000 deaths), 190,000 cases of acute myeloid leukemia (147,000 deaths), and 64,000 cases of chronic myeloid leukemia (35,000 deaths).

The data also show that, between 2005 and 2015, cancer cases increased by 33%, mostly due to population aging and growth, plus changes in age-specific cancer rates.

Globally, the odds of developing cancer during a lifetime were 1 in 3 for men and 1 in 4 for women in 2015.

Prostate cancer was the most common cancer in men (1.6 million cases), although tracheal, bronchus, and lung cancer was the leading cause of cancer deaths for men.

Breast cancer was the most common cancer for women (2.4 million cases) and the leading cause of cancer deaths in women.

The most common childhood cancers were leukemia, “other neoplasms,” NHL, and brain and nervous system cancers.

Structure of PTEN

Researchers say they have discovered an important molecular link between Fanconi anemia (FA) and PTEN, a gene associated with uterine, prostate, and brain cancer.

They say this discovery enhances our understanding of the molecular basis of Fanconi anemia and could lead to improved treatment outcomes for both Fanconi anemia and cancer patients.

The researchers detailed their discovery in Scientific Reports.

They explained that Fanconi anemia proteins function primarily in DNA interstrand crosslink (ICL) repair, and they wanted to determine the role of the PTEN phosphatase in this process.

“The PTEN gene codes for a phosphatase—an enzyme that removes phosphate groups from proteins,” said study author Niall Howlett, PhD, of the University of Rhode Island in Kingston, Rhode Island.

“Many Fanconi anemia proteins have phosphate groups attached to them when they become activated. However, how these phosphate groups are removed is poorly understood.”

With this in mind, the researchers performed an experiment to determine if Fanconi anemia and PTEN are biochemically linked.

The team knew that cells from Fanconi anemia patients are sensitive to ICL-inducing agents, so they set out to determine if PTEN-deficient cells are sensitive to these agents as well.

“By testing if cells with mutations in the PTEN gene were also sensitive to [ICL-inducing] agents, we discovered that Fanconi anemia patient cells and PTEN-deficient cells were practically indistinguishable in terms of sensitivity to these drugs,” Dr Howlett said.

“This strongly suggested that the Fanconi anemia proteins and PTEN might work together to repair the DNA damage caused by [ICL-inducing] agents.”

Using epistasis analysis, Dr Howlett and his colleagues found that Fanconi anemia proteins and PTEN do indeed function together in ICL repair.

“Before this work, Fanconi anemia and PTEN weren’t even on the same radar,” Dr Howlett said. “This is really important to understanding how this disease arises and what its molecular underpinnings are. The more we can find out about its molecular basis, the more likely we are to come up with strategies to treat the disease.”

Dr Howlett and his colleagues believe their research is equally important to cancer patients. Since this study showed that cells missing PTEN are highly sensitive to ICL-inducing agents, the team believes it should be possible to predict whether a particular cancer patient will respond to this class of drugs by conducting a simple DNA test.

“We can now predict that if a patient has cancer associated with mutations in PTEN, then it is likely that the cancer will be sensitive to [ICL-inducing] agents,” Dr Howlett said. “This could lead to improved outcomes for patients with certain types of PTEN mutations.”

Structure of PTEN

Researchers say they have discovered an important molecular link between Fanconi anemia (FA) and PTEN, a gene associated with uterine, prostate, and brain cancer.

They say this discovery enhances our understanding of the molecular basis of Fanconi anemia and could lead to improved treatment outcomes for both Fanconi anemia and cancer patients.

The researchers detailed their discovery in Scientific Reports.

They explained that Fanconi anemia proteins function primarily in DNA interstrand crosslink (ICL) repair, and they wanted to determine the role of the PTEN phosphatase in this process.

“The PTEN gene codes for a phosphatase—an enzyme that removes phosphate groups from proteins,” said study author Niall Howlett, PhD, of the University of Rhode Island in Kingston, Rhode Island.

“Many Fanconi anemia proteins have phosphate groups attached to them when they become activated. However, how these phosphate groups are removed is poorly understood.”

With this in mind, the researchers performed an experiment to determine if Fanconi anemia and PTEN are biochemically linked.

The team knew that cells from Fanconi anemia patients are sensitive to ICL-inducing agents, so they set out to determine if PTEN-deficient cells are sensitive to these agents as well.

“By testing if cells with mutations in the PTEN gene were also sensitive to [ICL-inducing] agents, we discovered that Fanconi anemia patient cells and PTEN-deficient cells were practically indistinguishable in terms of sensitivity to these drugs,” Dr Howlett said.

“This strongly suggested that the Fanconi anemia proteins and PTEN might work together to repair the DNA damage caused by [ICL-inducing] agents.”

Using epistasis analysis, Dr Howlett and his colleagues found that Fanconi anemia proteins and PTEN do indeed function together in ICL repair.

“Before this work, Fanconi anemia and PTEN weren’t even on the same radar,” Dr Howlett said. “This is really important to understanding how this disease arises and what its molecular underpinnings are. The more we can find out about its molecular basis, the more likely we are to come up with strategies to treat the disease.”

Dr Howlett and his colleagues believe their research is equally important to cancer patients. Since this study showed that cells missing PTEN are highly sensitive to ICL-inducing agents, the team believes it should be possible to predict whether a particular cancer patient will respond to this class of drugs by conducting a simple DNA test.

“We can now predict that if a patient has cancer associated with mutations in PTEN, then it is likely that the cancer will be sensitive to [ICL-inducing] agents,” Dr Howlett said. “This could lead to improved outcomes for patients with certain types of PTEN mutations.”

Structure of PTEN

Researchers say they have discovered an important molecular link between Fanconi anemia (FA) and PTEN, a gene associated with uterine, prostate, and brain cancer.

They say this discovery enhances our understanding of the molecular basis of Fanconi anemia and could lead to improved treatment outcomes for both Fanconi anemia and cancer patients.

The researchers detailed their discovery in Scientific Reports.

They explained that Fanconi anemia proteins function primarily in DNA interstrand crosslink (ICL) repair, and they wanted to determine the role of the PTEN phosphatase in this process.

“The PTEN gene codes for a phosphatase—an enzyme that removes phosphate groups from proteins,” said study author Niall Howlett, PhD, of the University of Rhode Island in Kingston, Rhode Island.

“Many Fanconi anemia proteins have phosphate groups attached to them when they become activated. However, how these phosphate groups are removed is poorly understood.”

With this in mind, the researchers performed an experiment to determine if Fanconi anemia and PTEN are biochemically linked.

The team knew that cells from Fanconi anemia patients are sensitive to ICL-inducing agents, so they set out to determine if PTEN-deficient cells are sensitive to these agents as well.

“By testing if cells with mutations in the PTEN gene were also sensitive to [ICL-inducing] agents, we discovered that Fanconi anemia patient cells and PTEN-deficient cells were practically indistinguishable in terms of sensitivity to these drugs,” Dr Howlett said.

“This strongly suggested that the Fanconi anemia proteins and PTEN might work together to repair the DNA damage caused by [ICL-inducing] agents.”

Using epistasis analysis, Dr Howlett and his colleagues found that Fanconi anemia proteins and PTEN do indeed function together in ICL repair.

“Before this work, Fanconi anemia and PTEN weren’t even on the same radar,” Dr Howlett said. “This is really important to understanding how this disease arises and what its molecular underpinnings are. The more we can find out about its molecular basis, the more likely we are to come up with strategies to treat the disease.”

Dr Howlett and his colleagues believe their research is equally important to cancer patients. Since this study showed that cells missing PTEN are highly sensitive to ICL-inducing agents, the team believes it should be possible to predict whether a particular cancer patient will respond to this class of drugs by conducting a simple DNA test.

“We can now predict that if a patient has cancer associated with mutations in PTEN, then it is likely that the cancer will be sensitive to [ICL-inducing] agents,” Dr Howlett said. “This could lead to improved outcomes for patients with certain types of PTEN mutations.”

A small community in the Lake

Kariba area of southern Zambia

where malaria elimination

programs are underway.

Photo from Milen Nikolov

Malaria elimination in historically high transmission areas like southern Africa is possible with tools that are already available, according to new research.

The study suggests that high levels of vector control are key, and mass drug campaigns cannot make much of an impact without proper vector control.

Milen Nikolov, of the Institute for Disease Modeling in Bellevue, Washington, and colleagues reported these findings in PLOS Computational Biology.

The researchers said the Lake Kariba region of Southern Province, Zambia, is part of a multi-country malaria elimination effort. However, elimination in this area is challenging because villages with high and low malaria burden are interconnected through human travel.

With this in mind, the researchers combined a mathematical model of malaria transmission with field data from Zambia to test a variety of strategies for eliminating malaria in the Lake Kariba region.

The team used detailed spatial surveillance data from field studies—including household locations, climate, clinical malaria incidence, prevalence of malaria infections, and bednet usage rates—to construct a model of interconnected villages, then tested a variety of intervention scenarios to see which ones could lead to elimination.

The results indicate that elimination requires high, yet realistic, levels of vector control. And mass drug campaigns deployed to kill parasites in the human population can boost the chances of achieving elimination as long as vector control is well-implemented.

The researchers said this work suggests that elimination programs in sub-Saharan Africa should focus on how to achieve and maintain excellent coverage of vector control measures rather than spending resources on mass drug campaigns that are predicted to have little effect without well-implemented vector control already in place.

Human movement within the region should be targeted to achieve elimination, as should the importation of infections from outside the region. This is because both impact the likelihood of achieving elimination and understanding regional movement patterns can help guide strategies on targeting specific groups of at-risk people.

While no sub-Saharan African country has yet eliminated malaria, the researchers predict that regional malaria elimination is within reach with current tools, provided the efficacy and operational efficiency attained in southern Zambia can be extended and targeted to other key areas.

A small community in the Lake

Kariba area of southern Zambia

where malaria elimination

programs are underway.

Photo from Milen Nikolov

Malaria elimination in historically high transmission areas like southern Africa is possible with tools that are already available, according to new research.

The study suggests that high levels of vector control are key, and mass drug campaigns cannot make much of an impact without proper vector control.

Milen Nikolov, of the Institute for Disease Modeling in Bellevue, Washington, and colleagues reported these findings in PLOS Computational Biology.

The researchers said the Lake Kariba region of Southern Province, Zambia, is part of a multi-country malaria elimination effort. However, elimination in this area is challenging because villages with high and low malaria burden are interconnected through human travel.

With this in mind, the researchers combined a mathematical model of malaria transmission with field data from Zambia to test a variety of strategies for eliminating malaria in the Lake Kariba region.

The team used detailed spatial surveillance data from field studies—including household locations, climate, clinical malaria incidence, prevalence of malaria infections, and bednet usage rates—to construct a model of interconnected villages, then tested a variety of intervention scenarios to see which ones could lead to elimination.

The results indicate that elimination requires high, yet realistic, levels of vector control. And mass drug campaigns deployed to kill parasites in the human population can boost the chances of achieving elimination as long as vector control is well-implemented.

The researchers said this work suggests that elimination programs in sub-Saharan Africa should focus on how to achieve and maintain excellent coverage of vector control measures rather than spending resources on mass drug campaigns that are predicted to have little effect without well-implemented vector control already in place.

Human movement within the region should be targeted to achieve elimination, as should the importation of infections from outside the region. This is because both impact the likelihood of achieving elimination and understanding regional movement patterns can help guide strategies on targeting specific groups of at-risk people.

While no sub-Saharan African country has yet eliminated malaria, the researchers predict that regional malaria elimination is within reach with current tools, provided the efficacy and operational efficiency attained in southern Zambia can be extended and targeted to other key areas.

A small community in the Lake

Kariba area of southern Zambia

where malaria elimination

programs are underway.

Photo from Milen Nikolov

Malaria elimination in historically high transmission areas like southern Africa is possible with tools that are already available, according to new research.

The study suggests that high levels of vector control are key, and mass drug campaigns cannot make much of an impact without proper vector control.

Milen Nikolov, of the Institute for Disease Modeling in Bellevue, Washington, and colleagues reported these findings in PLOS Computational Biology.

The researchers said the Lake Kariba region of Southern Province, Zambia, is part of a multi-country malaria elimination effort. However, elimination in this area is challenging because villages with high and low malaria burden are interconnected through human travel.

With this in mind, the researchers combined a mathematical model of malaria transmission with field data from Zambia to test a variety of strategies for eliminating malaria in the Lake Kariba region.

The team used detailed spatial surveillance data from field studies—including household locations, climate, clinical malaria incidence, prevalence of malaria infections, and bednet usage rates—to construct a model of interconnected villages, then tested a variety of intervention scenarios to see which ones could lead to elimination.

The results indicate that elimination requires high, yet realistic, levels of vector control. And mass drug campaigns deployed to kill parasites in the human population can boost the chances of achieving elimination as long as vector control is well-implemented.

The researchers said this work suggests that elimination programs in sub-Saharan Africa should focus on how to achieve and maintain excellent coverage of vector control measures rather than spending resources on mass drug campaigns that are predicted to have little effect without well-implemented vector control already in place.

Human movement within the region should be targeted to achieve elimination, as should the importation of infections from outside the region. This is because both impact the likelihood of achieving elimination and understanding regional movement patterns can help guide strategies on targeting specific groups of at-risk people.

While no sub-Saharan African country has yet eliminated malaria, the researchers predict that regional malaria elimination is within reach with current tools, provided the efficacy and operational efficiency attained in southern Zambia can be extended and targeted to other key areas.

Pembrolizumab (Keytruda)

Photo courtesy of Merck

The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for pembrolizumab (Keytruda®) as a treatment for patients with refractory classical Hodgkin lymphoma (cHL) and for cHL patients who have relapsed after 3 or more prior lines of therapy.

The sBLA will be reviewed under the FDA’s accelerated approval program. The target action date is March 15, 2017.

Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the antitumor immune response.

The drug, which is being developed by Merck, already has FDA approval as a treatment for melanoma, lung cancer, and head and neck cancer.

Pembrolizumab also has breakthrough therapy designation as a treatment for relapsed/refractory cHL.

The current sBLA for pembrolizumab is seeking approval for the drug at a fixed dose of 200 mg, administered intravenously every 3 weeks.

This is the first application for regulatory approval of pembrolizumab in a hematologic malignancy.

The sBLA is supported by data from the phase 1 KEYNOTE-013 trial and the phase 2 KEYNOTE-087 trial.

Results from KEYNOTE-013 (in cHL patients) were presented at the 2014 ASH Annual Meeting, and results from KEYNOTE-087 were presented at the 2016 ASCO Annual Meeting.

Pembrolizumab (Keytruda)

Photo courtesy of Merck

The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for pembrolizumab (Keytruda®) as a treatment for patients with refractory classical Hodgkin lymphoma (cHL) and for cHL patients who have relapsed after 3 or more prior lines of therapy.

The sBLA will be reviewed under the FDA’s accelerated approval program. The target action date is March 15, 2017.

Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the antitumor immune response.

The drug, which is being developed by Merck, already has FDA approval as a treatment for melanoma, lung cancer, and head and neck cancer.

Pembrolizumab also has breakthrough therapy designation as a treatment for relapsed/refractory cHL.

The current sBLA for pembrolizumab is seeking approval for the drug at a fixed dose of 200 mg, administered intravenously every 3 weeks.

This is the first application for regulatory approval of pembrolizumab in a hematologic malignancy.

The sBLA is supported by data from the phase 1 KEYNOTE-013 trial and the phase 2 KEYNOTE-087 trial.

Results from KEYNOTE-013 (in cHL patients) were presented at the 2014 ASH Annual Meeting, and results from KEYNOTE-087 were presented at the 2016 ASCO Annual Meeting.

Pembrolizumab (Keytruda)

Photo courtesy of Merck

The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for pembrolizumab (Keytruda®) as a treatment for patients with refractory classical Hodgkin lymphoma (cHL) and for cHL patients who have relapsed after 3 or more prior lines of therapy.

The sBLA will be reviewed under the FDA’s accelerated approval program. The target action date is March 15, 2017.

Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the antitumor immune response.

The drug, which is being developed by Merck, already has FDA approval as a treatment for melanoma, lung cancer, and head and neck cancer.

Pembrolizumab also has breakthrough therapy designation as a treatment for relapsed/refractory cHL.

The current sBLA for pembrolizumab is seeking approval for the drug at a fixed dose of 200 mg, administered intravenously every 3 weeks.

This is the first application for regulatory approval of pembrolizumab in a hematologic malignancy.

The sBLA is supported by data from the phase 1 KEYNOTE-013 trial and the phase 2 KEYNOTE-087 trial.

Results from KEYNOTE-013 (in cHL patients) were presented at the 2014 ASH Annual Meeting, and results from KEYNOTE-087 were presented at the 2016 ASCO Annual Meeting.

Blood sample

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Abbott Molecular Inc.’s RealTime ZIKA assay.

The EUA means the assay can be used by certified laboratories for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen).

Zika virus RNA is generally detectable in these specimens during the acute phase of infection.

According to updated guidance from the US Centers for Disease Control and Prevention (CDC), Zika virus RNA is detectable up to 14 days in serum and urine (possibly longer in urine), following the onset of symptoms, if present. Positive results are indicative of current infection.

The FDA’s decision to grant an EUA means Abbott’s RealTime ZIKA assay can be used in individuals who meet CDC Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

The assay can be used by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).

The EUA does not mean Abbott’s RealTime ZIKA assay is FDA cleared or approved.

An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

This means Abbott’s RealTime ZIKA assay is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.

Blood sample

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Abbott Molecular Inc.’s RealTime ZIKA assay.

The EUA means the assay can be used by certified laboratories for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen).

Zika virus RNA is generally detectable in these specimens during the acute phase of infection.

According to updated guidance from the US Centers for Disease Control and Prevention (CDC), Zika virus RNA is detectable up to 14 days in serum and urine (possibly longer in urine), following the onset of symptoms, if present. Positive results are indicative of current infection.

The FDA’s decision to grant an EUA means Abbott’s RealTime ZIKA assay can be used in individuals who meet CDC Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

The assay can be used by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).

The EUA does not mean Abbott’s RealTime ZIKA assay is FDA cleared or approved.

An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

This means Abbott’s RealTime ZIKA assay is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.

Blood sample

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Abbott Molecular Inc.’s RealTime ZIKA assay.

The EUA means the assay can be used by certified laboratories for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen).

Zika virus RNA is generally detectable in these specimens during the acute phase of infection.

According to updated guidance from the US Centers for Disease Control and Prevention (CDC), Zika virus RNA is detectable up to 14 days in serum and urine (possibly longer in urine), following the onset of symptoms, if present. Positive results are indicative of current infection.

The FDA’s decision to grant an EUA means Abbott’s RealTime ZIKA assay can be used in individuals who meet CDC Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

The assay can be used by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).

The EUA does not mean Abbott’s RealTime ZIKA assay is FDA cleared or approved.

An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

This means Abbott’s RealTime ZIKA assay is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.

Lab mice

Photo by Aaron Logan

Researchers have created a patch designed to monitor a patient’s blood and release heparin as needed to prevent thrombosis.

In mice, the patch successfully released heparin into the bloodstream and proved more effective at preventing thrombosis than an injection of heparin.

Zhen Gu, PhD, of the University of North Carolina at Chapel Hill, and his colleagues developed the patch and described it in Advanced Materials.

“Our goal was to generate a patch that can monitor a patient’s blood and release additional drugs when necessary; effectively, a self-regulating system,” Dr Gu said.

The patch incorporates microneedles made of a polymer that consists of hyaluronic acid (HA) and the drug heparin. The polymer has been modified to be responsive to thrombin.

When elevated levels of thrombin enzymes in the bloodstream come into contact with the microneedle, the enzymes break the amino acid chains that bind the heparin to the HA, releasing the heparin into the bloodstream.

“The more thrombin there is in the bloodstream, the more heparin is needed to reduce clotting,” said study author Yuqi Zhang, a PhD student in Dr Gu’s lab. “So we created a disposable patch in which the more thrombin there is in the bloodstream, the more heparin is released.”

“We will further enhance the loading amount of drug in the patch,” said study author Jicheng Yu, a PhD student in Dr Gu’s lab.

“The amount of heparin in a patch can be tailored to a patient’s specific needs and replaced daily, or less often, as needed. But the amount of heparin being released into the patient at any given moment will be determined by the thrombin levels in the patient’s blood.”

Experiments in mice

The researchers tested the patch in a mouse model of thrombosis. The mice were injected with large doses of thrombin (1000 U kg^-1) to induce an acute thromboembolism, which can lead to death in about 92% of mice.

The mice were then randomized into 5 different treatment groups:

• Intravenous heparin injection
• Empty HA microneedle patch
• HA microneedle patch encapsulating free heparin
• Thrombin-responsive HA-heparin microneedle patch
• Non-responsive HA-heparin microneedle patch (heparin dose: 200 U kg⁻¹).

The mice that received heparin via injection were treated before thrombosis induction. The microneedle patches were applied to the dorsum skin of the mice 10 minutes before the challenge.

All of the mice with the HA microneedle patch or the non-responsive HA-heparin microneedle patch died within 15 minutes of the thrombin injection.

All of the mice that received the heparin injection, heparin microneedle patch, or the thrombin-responsive HA-heparin microneedle patch survived the 15 minutes.

In a second experiment, mice received a thrombin injection 6 hours after treatment, and treatment consisted of:

• Heparin injection
• HA microneedle patch encapsulating free heparin
• Thrombin-responsive HA-heparin microneedle patch.

Fifteen minutes after the thrombin injection, death had occurred in 80% or more of the mice that received the heparin injection and the mice treated with the heparin microneedle patch.

But all of the mice treated with the thrombin-responsive HA-heparin microneedle patch survived.

The researchers also noted that staining of lung sections revealed the “superior anticoagulant capacity” of the thrombin-responsive HA-heparin microneedle patch.

The team observed “insignificant differences” in the lungs of healthy mice and mice treated with the thrombin-responsive HA-heparin microneedle patch.

However, mice that received a heparin injection or treatment with the heparin microneedle patch had intravascular and interstitial hemorrhage, blocked blood vessels, and atelectasis.

“We’re excited about the possibility of using a closed-loop, self-regulating smart patch to help treat a condition that affects thousands of people every year, while hopefully also driving down treatment costs,” Dr Gu said. “This paper represents a good first step, and we’re now looking for funding to perform additional preclinical testing.”

Lab mice

Photo by Aaron Logan

Researchers have created a patch designed to monitor a patient’s blood and release heparin as needed to prevent thrombosis.

In mice, the patch successfully released heparin into the bloodstream and proved more effective at preventing thrombosis than an injection of heparin.

Zhen Gu, PhD, of the University of North Carolina at Chapel Hill, and his colleagues developed the patch and described it in Advanced Materials.

“Our goal was to generate a patch that can monitor a patient’s blood and release additional drugs when necessary; effectively, a self-regulating system,” Dr Gu said.

The patch incorporates microneedles made of a polymer that consists of hyaluronic acid (HA) and the drug heparin. The polymer has been modified to be responsive to thrombin.

When elevated levels of thrombin enzymes in the bloodstream come into contact with the microneedle, the enzymes break the amino acid chains that bind the heparin to the HA, releasing the heparin into the bloodstream.

“The more thrombin there is in the bloodstream, the more heparin is needed to reduce clotting,” said study author Yuqi Zhang, a PhD student in Dr Gu’s lab. “So we created a disposable patch in which the more thrombin there is in the bloodstream, the more heparin is released.”

“We will further enhance the loading amount of drug in the patch,” said study author Jicheng Yu, a PhD student in Dr Gu’s lab.

“The amount of heparin in a patch can be tailored to a patient’s specific needs and replaced daily, or less often, as needed. But the amount of heparin being released into the patient at any given moment will be determined by the thrombin levels in the patient’s blood.”

Experiments in mice

The researchers tested the patch in a mouse model of thrombosis. The mice were injected with large doses of thrombin (1000 U kg^-1) to induce an acute thromboembolism, which can lead to death in about 92% of mice.

The mice were then randomized into 5 different treatment groups:

• Intravenous heparin injection
• Empty HA microneedle patch
• HA microneedle patch encapsulating free heparin
• Thrombin-responsive HA-heparin microneedle patch
• Non-responsive HA-heparin microneedle patch (heparin dose: 200 U kg⁻¹).

The mice that received heparin via injection were treated before thrombosis induction. The microneedle patches were applied to the dorsum skin of the mice 10 minutes before the challenge.

All of the mice with the HA microneedle patch or the non-responsive HA-heparin microneedle patch died within 15 minutes of the thrombin injection.

All of the mice that received the heparin injection, heparin microneedle patch, or the thrombin-responsive HA-heparin microneedle patch survived the 15 minutes.

In a second experiment, mice received a thrombin injection 6 hours after treatment, and treatment consisted of:

• Heparin injection
• HA microneedle patch encapsulating free heparin
• Thrombin-responsive HA-heparin microneedle patch.

Fifteen minutes after the thrombin injection, death had occurred in 80% or more of the mice that received the heparin injection and the mice treated with the heparin microneedle patch.

But all of the mice treated with the thrombin-responsive HA-heparin microneedle patch survived.

The researchers also noted that staining of lung sections revealed the “superior anticoagulant capacity” of the thrombin-responsive HA-heparin microneedle patch.

The team observed “insignificant differences” in the lungs of healthy mice and mice treated with the thrombin-responsive HA-heparin microneedle patch.

However, mice that received a heparin injection or treatment with the heparin microneedle patch had intravascular and interstitial hemorrhage, blocked blood vessels, and atelectasis.

“We’re excited about the possibility of using a closed-loop, self-regulating smart patch to help treat a condition that affects thousands of people every year, while hopefully also driving down treatment costs,” Dr Gu said. “This paper represents a good first step, and we’re now looking for funding to perform additional preclinical testing.”

Lab mice

Photo by Aaron Logan

Researchers have created a patch designed to monitor a patient’s blood and release heparin as needed to prevent thrombosis.

In mice, the patch successfully released heparin into the bloodstream and proved more effective at preventing thrombosis than an injection of heparin.

Zhen Gu, PhD, of the University of North Carolina at Chapel Hill, and his colleagues developed the patch and described it in Advanced Materials.

“Our goal was to generate a patch that can monitor a patient’s blood and release additional drugs when necessary; effectively, a self-regulating system,” Dr Gu said.

The patch incorporates microneedles made of a polymer that consists of hyaluronic acid (HA) and the drug heparin. The polymer has been modified to be responsive to thrombin.

When elevated levels of thrombin enzymes in the bloodstream come into contact with the microneedle, the enzymes break the amino acid chains that bind the heparin to the HA, releasing the heparin into the bloodstream.

“The more thrombin there is in the bloodstream, the more heparin is needed to reduce clotting,” said study author Yuqi Zhang, a PhD student in Dr Gu’s lab. “So we created a disposable patch in which the more thrombin there is in the bloodstream, the more heparin is released.”

“We will further enhance the loading amount of drug in the patch,” said study author Jicheng Yu, a PhD student in Dr Gu’s lab.

“The amount of heparin in a patch can be tailored to a patient’s specific needs and replaced daily, or less often, as needed. But the amount of heparin being released into the patient at any given moment will be determined by the thrombin levels in the patient’s blood.”

Experiments in mice

The researchers tested the patch in a mouse model of thrombosis. The mice were injected with large doses of thrombin (1000 U kg^-1) to induce an acute thromboembolism, which can lead to death in about 92% of mice.

The mice were then randomized into 5 different treatment groups:

• Intravenous heparin injection
• Empty HA microneedle patch
• HA microneedle patch encapsulating free heparin
• Thrombin-responsive HA-heparin microneedle patch
• Non-responsive HA-heparin microneedle patch (heparin dose: 200 U kg⁻¹).

The mice that received heparin via injection were treated before thrombosis induction. The microneedle patches were applied to the dorsum skin of the mice 10 minutes before the challenge.

All of the mice with the HA microneedle patch or the non-responsive HA-heparin microneedle patch died within 15 minutes of the thrombin injection.

All of the mice that received the heparin injection, heparin microneedle patch, or the thrombin-responsive HA-heparin microneedle patch survived the 15 minutes.

In a second experiment, mice received a thrombin injection 6 hours after treatment, and treatment consisted of:

• Heparin injection
• HA microneedle patch encapsulating free heparin
• Thrombin-responsive HA-heparin microneedle patch.

Fifteen minutes after the thrombin injection, death had occurred in 80% or more of the mice that received the heparin injection and the mice treated with the heparin microneedle patch.

But all of the mice treated with the thrombin-responsive HA-heparin microneedle patch survived.

The researchers also noted that staining of lung sections revealed the “superior anticoagulant capacity” of the thrombin-responsive HA-heparin microneedle patch.

The team observed “insignificant differences” in the lungs of healthy mice and mice treated with the thrombin-responsive HA-heparin microneedle patch.

However, mice that received a heparin injection or treatment with the heparin microneedle patch had intravascular and interstitial hemorrhage, blocked blood vessels, and atelectasis.

“We’re excited about the possibility of using a closed-loop, self-regulating smart patch to help treat a condition that affects thousands of people every year, while hopefully also driving down treatment costs,” Dr Gu said. “This paper represents a good first step, and we’re now looking for funding to perform additional preclinical testing.”

NCCN Guidelines for Patients®:

Nausea and Vomiting

©NCCN® 2016

The National Comprehensive Cancer Network (NCCN) has released new educational materials designed to help cancer patients combat nausea and vomiting.

The NCCN Guidelines for Patients® for Nausea and Vomiting and NCCN Quick Guide™ for Nausea and Vomiting are the first patient resources from NCCN to focus specifically on supportive care.

The resources are available on NCCN.org/patients and via the NCCN Patient Guides for Cancer mobile app.

NCCN Guidelines for Patients are patient-friendly translations of the NCCN Clinical Practice Guidelines in Oncology. Each resource features guidance from US cancer centers designed to help people living with cancer talk with their physicians about the best treatment options for their disease.

NCCN Quick Guide™ sheets are 1-page summaries of key points in the patient guidelines. They include elements such as “questions to ask your doctor,” a glossary of terms, and medical illustrations of anatomy, tests, and treatments.

The NCCN Guidelines for Patients for Nausea and Vomiting:

• Explain how these side effects are related to cancer treatment
• List cancer treatments that can cause nausea and vomiting
• Detail methods of preventing and treating these side effects
• Outline methods of coping with nausea and vomiting
• Provide a list of resources for information and support.

“At NCCN, our mission is to improve the lives of patients with cancer, and we are excited to be able to provide the information that will help patients better understand this common side effect of cancer treatment,” said Marcie R. Reeder, executive director of the NCCN Foundation.

“The NCCN Guidelines for Patients for Nausea and Vomiting are the first of a highly anticipated library of supportive care resources that provide patients with the same information their doctors use.”

NCCN Guidelines for Patients®:

Nausea and Vomiting

©NCCN® 2016

The National Comprehensive Cancer Network (NCCN) has released new educational materials designed to help cancer patients combat nausea and vomiting.

The NCCN Guidelines for Patients® for Nausea and Vomiting and NCCN Quick Guide™ for Nausea and Vomiting are the first patient resources from NCCN to focus specifically on supportive care.

The resources are available on NCCN.org/patients and via the NCCN Patient Guides for Cancer mobile app.

NCCN Guidelines for Patients are patient-friendly translations of the NCCN Clinical Practice Guidelines in Oncology. Each resource features guidance from US cancer centers designed to help people living with cancer talk with their physicians about the best treatment options for their disease.

NCCN Quick Guide™ sheets are 1-page summaries of key points in the patient guidelines. They include elements such as “questions to ask your doctor,” a glossary of terms, and medical illustrations of anatomy, tests, and treatments.

The NCCN Guidelines for Patients for Nausea and Vomiting:

• Explain how these side effects are related to cancer treatment
• List cancer treatments that can cause nausea and vomiting
• Detail methods of preventing and treating these side effects
• Outline methods of coping with nausea and vomiting
• Provide a list of resources for information and support.

“At NCCN, our mission is to improve the lives of patients with cancer, and we are excited to be able to provide the information that will help patients better understand this common side effect of cancer treatment,” said Marcie R. Reeder, executive director of the NCCN Foundation.

“The NCCN Guidelines for Patients for Nausea and Vomiting are the first of a highly anticipated library of supportive care resources that provide patients with the same information their doctors use.”

NCCN Guidelines for Patients®:

Nausea and Vomiting

©NCCN® 2016

The National Comprehensive Cancer Network (NCCN) has released new educational materials designed to help cancer patients combat nausea and vomiting.

The NCCN Guidelines for Patients® for Nausea and Vomiting and NCCN Quick Guide™ for Nausea and Vomiting are the first patient resources from NCCN to focus specifically on supportive care.

The resources are available on NCCN.org/patients and via the NCCN Patient Guides for Cancer mobile app.

NCCN Guidelines for Patients are patient-friendly translations of the NCCN Clinical Practice Guidelines in Oncology. Each resource features guidance from US cancer centers designed to help people living with cancer talk with their physicians about the best treatment options for their disease.

NCCN Quick Guide™ sheets are 1-page summaries of key points in the patient guidelines. They include elements such as “questions to ask your doctor,” a glossary of terms, and medical illustrations of anatomy, tests, and treatments.

The NCCN Guidelines for Patients for Nausea and Vomiting:

• Explain how these side effects are related to cancer treatment
• List cancer treatments that can cause nausea and vomiting
• Detail methods of preventing and treating these side effects
• Outline methods of coping with nausea and vomiting
• Provide a list of resources for information and support.

“At NCCN, our mission is to improve the lives of patients with cancer, and we are excited to be able to provide the information that will help patients better understand this common side effect of cancer treatment,” said Marcie R. Reeder, executive director of the NCCN Foundation.

“The NCCN Guidelines for Patients for Nausea and Vomiting are the first of a highly anticipated library of supportive care resources that provide patients with the same information their doctors use.”