Jae Park, MD

WASHINGTON, DC—Results of a retrospective study suggest pretreatment disease burden impacts the outcome of chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

Patients who had minimal residual disease (MRD) prior to treatment had superior event-free and overall survival compared to patients who had morphologic disease before treatment.

Patients with MRD were also less likely to experience cytokine release syndrome (CRS) and neurologic toxicity.

Jae Park, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, New York, presented these results at the AACR Annual Meeting 2017 (abstract CT078).

This study was funded by Juno Therapeutics, the National Cancer Institute, the Terry Fox Foundation, and MSKCC Experimental Therapeutics Center.

“[W]e and other groups have developed and tested CD19-specific [19-28z] CAR T-cell therapy and have reported encouraging results, with high initial complete response rates in patients with B-ALL,” Dr Park said.

“However, relapses are common, even after achieving seemingly deep remission, and severe toxicities have been observed in some patients.”

To gain more insight into these results, Dr Park and his colleagues retrospectively analyzed data from a prospective clinical trial that tested 19-28z CAR T-cell therapy in patients with B-ALL.

All 51 adults in this trial had relapsed after or were refractory to 1 or more conventional multiagent chemotherapy regimens.

The researchers measured disease burden prior to CAR T-cell infusion in all patients and divided them into 2 cohorts:

• 20 patients who had MRD—less than 5% blasts in the bone marrow
• 31 patients who had morphologic disease—5% or more blasts in the bone marrow.

Response and survival

The complete response rate was 95% in the MRD cohort and 77% in the morphologic disease cohort, a difference that was not statistically significant.

At a median follow-up of 18 months, the median event-free survival and overall survival had not been reached for patients in the MRD cohort (because most were still alive and disease-free).

However, for patients in the morphologic disease cohort, the median event-free survival was 6.3 months (P=0.0005), and the median overall survival was 17 months (P=0.0189).

Role of transplant

The researchers found that long-term survival did not improve for patients who proceeded to hematopoietic stem cell transplant (HSCT), regardless of their disease burden at baseline.

“While more patients and longer follow-up will be needed to adequately address the significance of HSCT, the result of this analysis raises a question as to whether 19-28z CAR therapy can be considered as a definitive, curative therapy rather than a bridge to stem cell transplant, at least in a subset of patients,” Dr Park noted.

“Our data suggest that incorporation of 19-28z CAR T cells at the time of MRD following first-line chemotherapy will maximize the durability of CAR T-cell-mediated remissions and survival and can potentially spare these high-risk patients from HSCT, rather than waiting until they relapse morphologically and then trying CAR T-cell therapy when it is less likely to achieve a durable long-term outcome.”

Adverse events and limitations

Patients from the MRD cohort fared better than the morphologic disease cohort in terms of CRS and neurologic toxicity.

Forty-two percent of patients in the morphologic disease cohort developed CRS, compared to 5% of patients in the MRD cohort (P=0.0326).

Neurologic toxicity occurred in 58% of patients in the morphologic disease cohort and 15% of those in the MRD cohort (P=0.0001).

Dr Park noted that a limitation of this study is its retrospective nature, and the findings will need to be validated prospectively.

Furthermore, the analysis on the impact of allogeneic HSCT was limited by a relatively small sample size in each cohort.

Jae Park, MD

WASHINGTON, DC—Results of a retrospective study suggest pretreatment disease burden impacts the outcome of chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

Patients who had minimal residual disease (MRD) prior to treatment had superior event-free and overall survival compared to patients who had morphologic disease before treatment.

Patients with MRD were also less likely to experience cytokine release syndrome (CRS) and neurologic toxicity.

Jae Park, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, New York, presented these results at the AACR Annual Meeting 2017 (abstract CT078).

This study was funded by Juno Therapeutics, the National Cancer Institute, the Terry Fox Foundation, and MSKCC Experimental Therapeutics Center.

“[W]e and other groups have developed and tested CD19-specific [19-28z] CAR T-cell therapy and have reported encouraging results, with high initial complete response rates in patients with B-ALL,” Dr Park said.

“However, relapses are common, even after achieving seemingly deep remission, and severe toxicities have been observed in some patients.”

To gain more insight into these results, Dr Park and his colleagues retrospectively analyzed data from a prospective clinical trial that tested 19-28z CAR T-cell therapy in patients with B-ALL.

All 51 adults in this trial had relapsed after or were refractory to 1 or more conventional multiagent chemotherapy regimens.

The researchers measured disease burden prior to CAR T-cell infusion in all patients and divided them into 2 cohorts:

• 20 patients who had MRD—less than 5% blasts in the bone marrow
• 31 patients who had morphologic disease—5% or more blasts in the bone marrow.

Response and survival

The complete response rate was 95% in the MRD cohort and 77% in the morphologic disease cohort, a difference that was not statistically significant.

At a median follow-up of 18 months, the median event-free survival and overall survival had not been reached for patients in the MRD cohort (because most were still alive and disease-free).

However, for patients in the morphologic disease cohort, the median event-free survival was 6.3 months (P=0.0005), and the median overall survival was 17 months (P=0.0189).

Role of transplant

The researchers found that long-term survival did not improve for patients who proceeded to hematopoietic stem cell transplant (HSCT), regardless of their disease burden at baseline.

“While more patients and longer follow-up will be needed to adequately address the significance of HSCT, the result of this analysis raises a question as to whether 19-28z CAR therapy can be considered as a definitive, curative therapy rather than a bridge to stem cell transplant, at least in a subset of patients,” Dr Park noted.

“Our data suggest that incorporation of 19-28z CAR T cells at the time of MRD following first-line chemotherapy will maximize the durability of CAR T-cell-mediated remissions and survival and can potentially spare these high-risk patients from HSCT, rather than waiting until they relapse morphologically and then trying CAR T-cell therapy when it is less likely to achieve a durable long-term outcome.”

Adverse events and limitations

Patients from the MRD cohort fared better than the morphologic disease cohort in terms of CRS and neurologic toxicity.

Forty-two percent of patients in the morphologic disease cohort developed CRS, compared to 5% of patients in the MRD cohort (P=0.0326).

Neurologic toxicity occurred in 58% of patients in the morphologic disease cohort and 15% of those in the MRD cohort (P=0.0001).

Dr Park noted that a limitation of this study is its retrospective nature, and the findings will need to be validated prospectively.

Furthermore, the analysis on the impact of allogeneic HSCT was limited by a relatively small sample size in each cohort.

Jae Park, MD

WASHINGTON, DC—Results of a retrospective study suggest pretreatment disease burden impacts the outcome of chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

Patients who had minimal residual disease (MRD) prior to treatment had superior event-free and overall survival compared to patients who had morphologic disease before treatment.

Patients with MRD were also less likely to experience cytokine release syndrome (CRS) and neurologic toxicity.

Jae Park, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, New York, presented these results at the AACR Annual Meeting 2017 (abstract CT078).

This study was funded by Juno Therapeutics, the National Cancer Institute, the Terry Fox Foundation, and MSKCC Experimental Therapeutics Center.

“[W]e and other groups have developed and tested CD19-specific [19-28z] CAR T-cell therapy and have reported encouraging results, with high initial complete response rates in patients with B-ALL,” Dr Park said.

“However, relapses are common, even after achieving seemingly deep remission, and severe toxicities have been observed in some patients.”

To gain more insight into these results, Dr Park and his colleagues retrospectively analyzed data from a prospective clinical trial that tested 19-28z CAR T-cell therapy in patients with B-ALL.

All 51 adults in this trial had relapsed after or were refractory to 1 or more conventional multiagent chemotherapy regimens.

The researchers measured disease burden prior to CAR T-cell infusion in all patients and divided them into 2 cohorts:

• 20 patients who had MRD—less than 5% blasts in the bone marrow
• 31 patients who had morphologic disease—5% or more blasts in the bone marrow.

Response and survival

The complete response rate was 95% in the MRD cohort and 77% in the morphologic disease cohort, a difference that was not statistically significant.

At a median follow-up of 18 months, the median event-free survival and overall survival had not been reached for patients in the MRD cohort (because most were still alive and disease-free).

However, for patients in the morphologic disease cohort, the median event-free survival was 6.3 months (P=0.0005), and the median overall survival was 17 months (P=0.0189).

Role of transplant

The researchers found that long-term survival did not improve for patients who proceeded to hematopoietic stem cell transplant (HSCT), regardless of their disease burden at baseline.

“While more patients and longer follow-up will be needed to adequately address the significance of HSCT, the result of this analysis raises a question as to whether 19-28z CAR therapy can be considered as a definitive, curative therapy rather than a bridge to stem cell transplant, at least in a subset of patients,” Dr Park noted.

“Our data suggest that incorporation of 19-28z CAR T cells at the time of MRD following first-line chemotherapy will maximize the durability of CAR T-cell-mediated remissions and survival and can potentially spare these high-risk patients from HSCT, rather than waiting until they relapse morphologically and then trying CAR T-cell therapy when it is less likely to achieve a durable long-term outcome.”

Adverse events and limitations

Patients from the MRD cohort fared better than the morphologic disease cohort in terms of CRS and neurologic toxicity.

Forty-two percent of patients in the morphologic disease cohort developed CRS, compared to 5% of patients in the MRD cohort (P=0.0326).

Neurologic toxicity occurred in 58% of patients in the morphologic disease cohort and 15% of those in the MRD cohort (P=0.0001).

Dr Park noted that a limitation of this study is its retrospective nature, and the findings will need to be validated prospectively.

Furthermore, the analysis on the impact of allogeneic HSCT was limited by a relatively small sample size in each cohort.

Image by Spencer Phillips

The US Food and Drug Administration (FDA) has authorized marketing of 23andMe Personal Genome Service (PGS) Genetic Health Risk (GHR) tests for 10 medical conditions.

These are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain conditions, including factor XI deficiency, glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary hemochromatosis, hereditary thrombophilia, and other conditions.

The GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants.

Consumers receive reports of the results, which tell them if they have an increased risk of developing any of the following 10 conditions.

Factor XI deficiency

The 23andMe PGS Genetic Health Risk Report for Factor XI Deficiency is indicated for reporting of the F283L, E117X, and IVS14+1G>A variants in the F11 gene.

This report describes if a person has a variant associated with factor XI deficiency and the potential for a higher risk of excessive bleeding following trauma or surgery, but it does not describe a person’s overall risk for excessive bleeding. This report is most relevant for people of Ashkenazi Jewish descent.

G6PD deficiency

The 23andMe PGS Genetic Health Risk Report for Glucose-6-Phosphate-Dehydrogenase Deficiency is indicated for reporting of the Val68Met variant in the G6PD gene.

This report describes if a person has a variant associated with G6PD deficiency and a higher risk for episodes of anemia, but it does not describe a person’s overall risk of developing anemia. This report is most relevant for people of African descent.

Hereditary hemochromatosis

The 23andMe PGS Genetic Health Risk Report for Hereditary Hemochromatosis is indicated for reporting of the C282Y and H63D variants in the HFE gene.

This report describes if a person has variants associated with hereditary hemochromatosis and a higher risk for iron overload, but it does not describe a person’s overall risk of developing iron overload. This report is most relevant for people of European descent.

Hereditary thrombophilia

The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the factor V Leiden variant in the F5 gene, as well as the prothrombin G20210A variant in the F2 gene.

This report describes if a person has variants associated with a higher risk of thrombosis, but it does not describe a person’s overall risk of developing thrombosis. This report is most relevant for people of European descent.

Alpha-1 antitrypsin deficiency (AATD)

The 23andMe PGS Genetic Health Risk Report for Alpha-I Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene.

This report describes if a person has variants associated with AATD and a higher risk for lung or liver disease, but it does not describe a person’s overall risk of developing lung or liver disease. This report is most relevant for people of European descent.

Celiac disease

The 23andMe PGS Genetic Health Risk Report for Celiac Disease is indicated for reporting of a variant in the HLA-DQ2.5 haplotype.

The report describes if a person has a haplotype associated with an increased risk of developing celiac disease, but it does not describe a person’s overall risk for developing celiac disease. This report is most relevant for people of European descent.

Early onset primary dystonia (DYT1/TOR1A-related)

The 23andMe PGS Genetic Health Risk Report for Early-Onset Primary Dystonia (DYT1/TOR1A-Related) is indicated for reporting of the deltaE302/303 variant in the DYT1 gene.

This report describes if a person has variants associated with a higher risk for early-onset primary dystonia, but it does not describe a person’s overall risk of developing dystonia. This report is most relevant for people of Ashkenazi Jewish descent.

Gaucher disease

The 23andMe PGS Genetic Health Risk Report for Gaucher Disease Type 1 is indicated for reporting of the N370S, 84GG, and V394L variants in the GBA gene.

This report describes if a person has variants associated with an increased risk for developing carrier status for Gaucher disease type 1 in adults. This report also describes if a result is associated with personal risk for developing symptoms of Gaucher disease type 1, but it does not describe a person’s overall risk of developing Gaucher disease type 1.

This test is most relevant for people of Ashkenazi Jewish descent.

Late-onset Alzheimer’s disease

The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer’s Disease is indicated for reporting of the ε4 variant in the APOE gene.

The report describes if a person’s genetic result is associated with an increased risk of developing late-onset Alzheimer’s disease, but it does not describe a person’s overall risk of developing Alzheimer’s disease.

The ε4 variant included in this report is found and has been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent.

Parkinson’s disease

The 23andMe PGS Genetic Health Risk Report for Parkinson’s Disease is indicated for reporting of the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene.

The report describes if a person’s genetic result is associated with an increased risk of developing Parkinson’s disease, but it does not describe a person’s overall risk of developing Parkinson’s disease. The test is most relevant for people of European, Ashkenazi Jewish, and North African Berber descent.

Access to testing

23andMe, Inc. said it will release its first set of GHR tests—for hereditary thrombophilia, late-onset Alzheimer’s disease, Parkinson’s disease, alpha-1 antitrypsin deficiency, and Gaucher disease—this month. The remaining tests will follow.

New 23andMe Health + Ancestry Service customers in the US will have access to these tests. Current 23andMe customers will be notified directly regarding their eligibility.

About the marketing authorization

The FDA reviewed data for the 23andMe GHR tests through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.

Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the tests’ accuracy, reliability, and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar GHR tests.

The FDA intends to exempt additional 23andMe GHR tests from premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification. A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible after a one-time FDA review.

Excluded from the current marketing authorization and any future, related exemption are GHR tests that function as diagnostic tests.

Image by Spencer Phillips

The US Food and Drug Administration (FDA) has authorized marketing of 23andMe Personal Genome Service (PGS) Genetic Health Risk (GHR) tests for 10 medical conditions.

These are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain conditions, including factor XI deficiency, glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary hemochromatosis, hereditary thrombophilia, and other conditions.

The GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants.

Consumers receive reports of the results, which tell them if they have an increased risk of developing any of the following 10 conditions.

Factor XI deficiency

The 23andMe PGS Genetic Health Risk Report for Factor XI Deficiency is indicated for reporting of the F283L, E117X, and IVS14+1G>A variants in the F11 gene.

This report describes if a person has a variant associated with factor XI deficiency and the potential for a higher risk of excessive bleeding following trauma or surgery, but it does not describe a person’s overall risk for excessive bleeding. This report is most relevant for people of Ashkenazi Jewish descent.

G6PD deficiency

The 23andMe PGS Genetic Health Risk Report for Glucose-6-Phosphate-Dehydrogenase Deficiency is indicated for reporting of the Val68Met variant in the G6PD gene.

This report describes if a person has a variant associated with G6PD deficiency and a higher risk for episodes of anemia, but it does not describe a person’s overall risk of developing anemia. This report is most relevant for people of African descent.

Hereditary hemochromatosis

The 23andMe PGS Genetic Health Risk Report for Hereditary Hemochromatosis is indicated for reporting of the C282Y and H63D variants in the HFE gene.

This report describes if a person has variants associated with hereditary hemochromatosis and a higher risk for iron overload, but it does not describe a person’s overall risk of developing iron overload. This report is most relevant for people of European descent.

Hereditary thrombophilia

The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the factor V Leiden variant in the F5 gene, as well as the prothrombin G20210A variant in the F2 gene.

This report describes if a person has variants associated with a higher risk of thrombosis, but it does not describe a person’s overall risk of developing thrombosis. This report is most relevant for people of European descent.

Alpha-1 antitrypsin deficiency (AATD)

The 23andMe PGS Genetic Health Risk Report for Alpha-I Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene.

This report describes if a person has variants associated with AATD and a higher risk for lung or liver disease, but it does not describe a person’s overall risk of developing lung or liver disease. This report is most relevant for people of European descent.

Celiac disease

The 23andMe PGS Genetic Health Risk Report for Celiac Disease is indicated for reporting of a variant in the HLA-DQ2.5 haplotype.

The report describes if a person has a haplotype associated with an increased risk of developing celiac disease, but it does not describe a person’s overall risk for developing celiac disease. This report is most relevant for people of European descent.

Early onset primary dystonia (DYT1/TOR1A-related)

The 23andMe PGS Genetic Health Risk Report for Early-Onset Primary Dystonia (DYT1/TOR1A-Related) is indicated for reporting of the deltaE302/303 variant in the DYT1 gene.

This report describes if a person has variants associated with a higher risk for early-onset primary dystonia, but it does not describe a person’s overall risk of developing dystonia. This report is most relevant for people of Ashkenazi Jewish descent.

Gaucher disease

The 23andMe PGS Genetic Health Risk Report for Gaucher Disease Type 1 is indicated for reporting of the N370S, 84GG, and V394L variants in the GBA gene.

This report describes if a person has variants associated with an increased risk for developing carrier status for Gaucher disease type 1 in adults. This report also describes if a result is associated with personal risk for developing symptoms of Gaucher disease type 1, but it does not describe a person’s overall risk of developing Gaucher disease type 1.

This test is most relevant for people of Ashkenazi Jewish descent.

Late-onset Alzheimer’s disease

The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer’s Disease is indicated for reporting of the ε4 variant in the APOE gene.

The report describes if a person’s genetic result is associated with an increased risk of developing late-onset Alzheimer’s disease, but it does not describe a person’s overall risk of developing Alzheimer’s disease.

The ε4 variant included in this report is found and has been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent.

Parkinson’s disease

The 23andMe PGS Genetic Health Risk Report for Parkinson’s Disease is indicated for reporting of the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene.

The report describes if a person’s genetic result is associated with an increased risk of developing Parkinson’s disease, but it does not describe a person’s overall risk of developing Parkinson’s disease. The test is most relevant for people of European, Ashkenazi Jewish, and North African Berber descent.

Access to testing

23andMe, Inc. said it will release its first set of GHR tests—for hereditary thrombophilia, late-onset Alzheimer’s disease, Parkinson’s disease, alpha-1 antitrypsin deficiency, and Gaucher disease—this month. The remaining tests will follow.

New 23andMe Health + Ancestry Service customers in the US will have access to these tests. Current 23andMe customers will be notified directly regarding their eligibility.

About the marketing authorization

The FDA reviewed data for the 23andMe GHR tests through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.

Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the tests’ accuracy, reliability, and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar GHR tests.

The FDA intends to exempt additional 23andMe GHR tests from premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification. A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible after a one-time FDA review.

Excluded from the current marketing authorization and any future, related exemption are GHR tests that function as diagnostic tests.

Image by Spencer Phillips

The US Food and Drug Administration (FDA) has authorized marketing of 23andMe Personal Genome Service (PGS) Genetic Health Risk (GHR) tests for 10 medical conditions.

These are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain conditions, including factor XI deficiency, glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary hemochromatosis, hereditary thrombophilia, and other conditions.

The GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants.

Consumers receive reports of the results, which tell them if they have an increased risk of developing any of the following 10 conditions.

Factor XI deficiency

The 23andMe PGS Genetic Health Risk Report for Factor XI Deficiency is indicated for reporting of the F283L, E117X, and IVS14+1G>A variants in the F11 gene.

This report describes if a person has a variant associated with factor XI deficiency and the potential for a higher risk of excessive bleeding following trauma or surgery, but it does not describe a person’s overall risk for excessive bleeding. This report is most relevant for people of Ashkenazi Jewish descent.

G6PD deficiency

The 23andMe PGS Genetic Health Risk Report for Glucose-6-Phosphate-Dehydrogenase Deficiency is indicated for reporting of the Val68Met variant in the G6PD gene.

This report describes if a person has a variant associated with G6PD deficiency and a higher risk for episodes of anemia, but it does not describe a person’s overall risk of developing anemia. This report is most relevant for people of African descent.

Hereditary hemochromatosis

The 23andMe PGS Genetic Health Risk Report for Hereditary Hemochromatosis is indicated for reporting of the C282Y and H63D variants in the HFE gene.

This report describes if a person has variants associated with hereditary hemochromatosis and a higher risk for iron overload, but it does not describe a person’s overall risk of developing iron overload. This report is most relevant for people of European descent.

Hereditary thrombophilia

The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the factor V Leiden variant in the F5 gene, as well as the prothrombin G20210A variant in the F2 gene.

This report describes if a person has variants associated with a higher risk of thrombosis, but it does not describe a person’s overall risk of developing thrombosis. This report is most relevant for people of European descent.

Alpha-1 antitrypsin deficiency (AATD)

The 23andMe PGS Genetic Health Risk Report for Alpha-I Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene.

This report describes if a person has variants associated with AATD and a higher risk for lung or liver disease, but it does not describe a person’s overall risk of developing lung or liver disease. This report is most relevant for people of European descent.

Celiac disease

The 23andMe PGS Genetic Health Risk Report for Celiac Disease is indicated for reporting of a variant in the HLA-DQ2.5 haplotype.

The report describes if a person has a haplotype associated with an increased risk of developing celiac disease, but it does not describe a person’s overall risk for developing celiac disease. This report is most relevant for people of European descent.

Early onset primary dystonia (DYT1/TOR1A-related)

The 23andMe PGS Genetic Health Risk Report for Early-Onset Primary Dystonia (DYT1/TOR1A-Related) is indicated for reporting of the deltaE302/303 variant in the DYT1 gene.

This report describes if a person has variants associated with a higher risk for early-onset primary dystonia, but it does not describe a person’s overall risk of developing dystonia. This report is most relevant for people of Ashkenazi Jewish descent.

Gaucher disease

The 23andMe PGS Genetic Health Risk Report for Gaucher Disease Type 1 is indicated for reporting of the N370S, 84GG, and V394L variants in the GBA gene.

This report describes if a person has variants associated with an increased risk for developing carrier status for Gaucher disease type 1 in adults. This report also describes if a result is associated with personal risk for developing symptoms of Gaucher disease type 1, but it does not describe a person’s overall risk of developing Gaucher disease type 1.

This test is most relevant for people of Ashkenazi Jewish descent.

Late-onset Alzheimer’s disease

The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer’s Disease is indicated for reporting of the ε4 variant in the APOE gene.

The report describes if a person’s genetic result is associated with an increased risk of developing late-onset Alzheimer’s disease, but it does not describe a person’s overall risk of developing Alzheimer’s disease.

The ε4 variant included in this report is found and has been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent.

Parkinson’s disease

The 23andMe PGS Genetic Health Risk Report for Parkinson’s Disease is indicated for reporting of the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene.

The report describes if a person’s genetic result is associated with an increased risk of developing Parkinson’s disease, but it does not describe a person’s overall risk of developing Parkinson’s disease. The test is most relevant for people of European, Ashkenazi Jewish, and North African Berber descent.

Access to testing

23andMe, Inc. said it will release its first set of GHR tests—for hereditary thrombophilia, late-onset Alzheimer’s disease, Parkinson’s disease, alpha-1 antitrypsin deficiency, and Gaucher disease—this month. The remaining tests will follow.

New 23andMe Health + Ancestry Service customers in the US will have access to these tests. Current 23andMe customers will be notified directly regarding their eligibility.

About the marketing authorization

The FDA reviewed data for the 23andMe GHR tests through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.

Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the tests’ accuracy, reliability, and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar GHR tests.

The FDA intends to exempt additional 23andMe GHR tests from premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification. A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible after a one-time FDA review.

Excluded from the current marketing authorization and any future, related exemption are GHR tests that function as diagnostic tests.

Photo by Elise Amendola

The European Commission (EC) has published guides intended to help hospitals and national authorities implement patient blood management (PBM) programs throughout the European Union.

The EC said its guide for hospitals is intended to help them implement PBM in a practical way, building on already recognized best practices.

The guide is the result of the combined expertise of clinicians and PBM professionals and the experience gathered from a 30-month pilot program implementing PBM in 5 European teaching hospitals.

The EC said this guide is relevant for all medical professionals and organizations involved in caring for patients suffering from anemia, blood loss, and medical conditions that might require transfusion.

The EC’s other PBM guide is intended for national authorities. It lists 10 “essential public health operations,” which encompass a range of activities authorities can engage in to aid the implementation of PBM in their health systems.

The essential public health operations (and examples of activities) are:

1. Surveillance—eg, continuously collect patient-level data on anemia, transfusion, and outcomes to measure and guide the implementation of PBM as a standard of care
2. Monitoring—eg, recommend the monitoring and flagging of too liberal blood component utilization to prevent health hazards
3. Health protection—eg, develop information and education materials for clinicians, quality and safety managers, and hospital administrators
4. Health promotion—eg, promote awareness of iron deficiency and iron deficiency anemia
5. Disease prevention—eg, create a sense of urgency for PBM as a new evidence-based standard of care through professional training and education
6. Governance—eg, create and institute a national PBM steering committee under the authority of the Ministry of Health
7. Workforce, equipment, and facilities—eg, provide hospital facilities for PBM
8. Organization and funding—eg, organize reallocation of funds and resources toward PBM
9. Communication—eg, provide PBM webpage sections for patients, health professionals, and health administrators
10. Research—eg, conduct PBM-related studies focusing on patient outcomes, cost-effectiveness, etc.

The EC said the publication of their PBM guides is timely, as the journal Transfusion recently published results from a 5-year PBM program in Western Australia, which is the world’s largest PBM program to date. The program included 605,046 patients admitted to 4 major adult tertiary-care hospitals.

The use of blood products was reduced by 41% during the study period. The program also resulted in a 28% reduction in hospital mortality, a 15% reduction in the average hospital length of stay, a 21% decrease in hospital-acquired infections, and a 31% decrease in the incidence of heart attack or stroke.

Photo by Elise Amendola

The European Commission (EC) has published guides intended to help hospitals and national authorities implement patient blood management (PBM) programs throughout the European Union.

The EC said its guide for hospitals is intended to help them implement PBM in a practical way, building on already recognized best practices.

The guide is the result of the combined expertise of clinicians and PBM professionals and the experience gathered from a 30-month pilot program implementing PBM in 5 European teaching hospitals.

The EC said this guide is relevant for all medical professionals and organizations involved in caring for patients suffering from anemia, blood loss, and medical conditions that might require transfusion.

The EC’s other PBM guide is intended for national authorities. It lists 10 “essential public health operations,” which encompass a range of activities authorities can engage in to aid the implementation of PBM in their health systems.

The essential public health operations (and examples of activities) are:

1. Surveillance—eg, continuously collect patient-level data on anemia, transfusion, and outcomes to measure and guide the implementation of PBM as a standard of care
2. Monitoring—eg, recommend the monitoring and flagging of too liberal blood component utilization to prevent health hazards
3. Health protection—eg, develop information and education materials for clinicians, quality and safety managers, and hospital administrators
4. Health promotion—eg, promote awareness of iron deficiency and iron deficiency anemia
5. Disease prevention—eg, create a sense of urgency for PBM as a new evidence-based standard of care through professional training and education
6. Governance—eg, create and institute a national PBM steering committee under the authority of the Ministry of Health
7. Workforce, equipment, and facilities—eg, provide hospital facilities for PBM
8. Organization and funding—eg, organize reallocation of funds and resources toward PBM
9. Communication—eg, provide PBM webpage sections for patients, health professionals, and health administrators
10. Research—eg, conduct PBM-related studies focusing on patient outcomes, cost-effectiveness, etc.

The EC said the publication of their PBM guides is timely, as the journal Transfusion recently published results from a 5-year PBM program in Western Australia, which is the world’s largest PBM program to date. The program included 605,046 patients admitted to 4 major adult tertiary-care hospitals.

The use of blood products was reduced by 41% during the study period. The program also resulted in a 28% reduction in hospital mortality, a 15% reduction in the average hospital length of stay, a 21% decrease in hospital-acquired infections, and a 31% decrease in the incidence of heart attack or stroke.

Photo by Elise Amendola

The European Commission (EC) has published guides intended to help hospitals and national authorities implement patient blood management (PBM) programs throughout the European Union.

The EC said its guide for hospitals is intended to help them implement PBM in a practical way, building on already recognized best practices.

The guide is the result of the combined expertise of clinicians and PBM professionals and the experience gathered from a 30-month pilot program implementing PBM in 5 European teaching hospitals.

The EC said this guide is relevant for all medical professionals and organizations involved in caring for patients suffering from anemia, blood loss, and medical conditions that might require transfusion.

The EC’s other PBM guide is intended for national authorities. It lists 10 “essential public health operations,” which encompass a range of activities authorities can engage in to aid the implementation of PBM in their health systems.

The essential public health operations (and examples of activities) are:

1. Surveillance—eg, continuously collect patient-level data on anemia, transfusion, and outcomes to measure and guide the implementation of PBM as a standard of care
2. Monitoring—eg, recommend the monitoring and flagging of too liberal blood component utilization to prevent health hazards
3. Health protection—eg, develop information and education materials for clinicians, quality and safety managers, and hospital administrators
4. Health promotion—eg, promote awareness of iron deficiency and iron deficiency anemia
5. Disease prevention—eg, create a sense of urgency for PBM as a new evidence-based standard of care through professional training and education
6. Governance—eg, create and institute a national PBM steering committee under the authority of the Ministry of Health
7. Workforce, equipment, and facilities—eg, provide hospital facilities for PBM
8. Organization and funding—eg, organize reallocation of funds and resources toward PBM
9. Communication—eg, provide PBM webpage sections for patients, health professionals, and health administrators
10. Research—eg, conduct PBM-related studies focusing on patient outcomes, cost-effectiveness, etc.

The EC said the publication of their PBM guides is timely, as the journal Transfusion recently published results from a 5-year PBM program in Western Australia, which is the world’s largest PBM program to date. The program included 605,046 patients admitted to 4 major adult tertiary-care hospitals.

The use of blood products was reduced by 41% during the study period. The program also resulted in a 28% reduction in hospital mortality, a 15% reduction in the average hospital length of stay, a 21% decrease in hospital-acquired infections, and a 31% decrease in the incidence of heart attack or stroke.

Saturday at the annual meeting of the American Association for Thoracic Surgery will feature a course dedicated to exploring novel techniques in heart and lung transplant, mechanical circulatory support, and ECMO, among other things.

“The schedule is pretty self-explanatory,” according to course chair Matthew D. Bacchetta, MD, of Columbia University in New York City. “We’ll be getting really good reviews from some of the best centers around the world.”

Saturday at the annual meeting of the American Association for Thoracic Surgery will feature a course dedicated to exploring novel techniques in heart and lung transplant, mechanical circulatory support, and ECMO, among other things.

“The schedule is pretty self-explanatory,” according to course chair Matthew D. Bacchetta, MD, of Columbia University in New York City. “We’ll be getting really good reviews from some of the best centers around the world.”

Saturday at the annual meeting of the American Association for Thoracic Surgery will feature a course dedicated to exploring novel techniques in heart and lung transplant, mechanical circulatory support, and ECMO, among other things.

“The schedule is pretty self-explanatory,” according to course chair Matthew D. Bacchetta, MD, of Columbia University in New York City. “We’ll be getting really good reviews from some of the best centers around the world.”

The AATS and AmSECT Welcome Reception will be held on Sunday, April 30, from 5:00 p.m. to 7:00 p.m. in the Exhibit Hall of the Hynes Convention Center. Admission to this event is complimentary to all registered attendees and exhibitors of both the AATS and AmSECT meetings.

Join the AATS and AmSECT, for the official opening to this year’s meeting. Visit with valued exhibitors and supporters in the Exhibition Hall, where you will learn cutting-edge techniques, and discover groundbreaking new products while networking with other attendees.

In celebration of the Centennial for AATS, many exhibits will include historic artifacts in the field of cardiothoracic surgery for all to see. The AATS and AmSECT Exhibition offers a number of exciting learning opportunities:

AATS Mini Theaters: “Deep Dive” presentations of top abstracts from this year’s Annual Meeting as well as product demonstrations by from industry partners.

AATS Learning Center: Innovative surgical procedures as well as webcasts from other AATS events such as the Mitral Conclave meeting.

AmSECT Poster Presentations

AATS Resident Poster CompetitionThe Perioperative/Team-Based Care Poster Competition

The AATS and AmSECT Welcome Reception will be held on Sunday, April 30, from 5:00 p.m. to 7:00 p.m. in the Exhibit Hall of the Hynes Convention Center. Admission to this event is complimentary to all registered attendees and exhibitors of both the AATS and AmSECT meetings.

Join the AATS and AmSECT, for the official opening to this year’s meeting. Visit with valued exhibitors and supporters in the Exhibition Hall, where you will learn cutting-edge techniques, and discover groundbreaking new products while networking with other attendees.

In celebration of the Centennial for AATS, many exhibits will include historic artifacts in the field of cardiothoracic surgery for all to see. The AATS and AmSECT Exhibition offers a number of exciting learning opportunities:

AATS Mini Theaters: “Deep Dive” presentations of top abstracts from this year’s Annual Meeting as well as product demonstrations by from industry partners.

AATS Learning Center: Innovative surgical procedures as well as webcasts from other AATS events such as the Mitral Conclave meeting.

AmSECT Poster Presentations

AATS Resident Poster CompetitionThe Perioperative/Team-Based Care Poster Competition

The AATS and AmSECT Welcome Reception will be held on Sunday, April 30, from 5:00 p.m. to 7:00 p.m. in the Exhibit Hall of the Hynes Convention Center. Admission to this event is complimentary to all registered attendees and exhibitors of both the AATS and AmSECT meetings.

Join the AATS and AmSECT, for the official opening to this year’s meeting. Visit with valued exhibitors and supporters in the Exhibition Hall, where you will learn cutting-edge techniques, and discover groundbreaking new products while networking with other attendees.

In celebration of the Centennial for AATS, many exhibits will include historic artifacts in the field of cardiothoracic surgery for all to see. The AATS and AmSECT Exhibition offers a number of exciting learning opportunities:

AATS Mini Theaters: “Deep Dive” presentations of top abstracts from this year’s Annual Meeting as well as product demonstrations by from industry partners.

AATS Learning Center: Innovative surgical procedures as well as webcasts from other AATS events such as the Mitral Conclave meeting.

AmSECT Poster Presentations

AATS Resident Poster CompetitionThe Perioperative/Team-Based Care Poster Competition

Managing thoracic tumors will be the focus of a multifaceted course set to take place in Saturday morning’s “General Thoracic Skills: Management of Thoracic Tumors in 2017” session.

“Thoracic surgical approaches and techniques are in constant evolution,” said course chair Virginia R. Litle, MD, of the Boston Medical Center. “Less invasive approaches are available for diagnosing and staging thoracic malignancies, for preoperative planning and avoidance, and for management of complications, [so] we will hear from experts in the field about preoperative planning techniques that are increasingly available.”

Managing thoracic tumors will be the focus of a multifaceted course set to take place in Saturday morning’s “General Thoracic Skills: Management of Thoracic Tumors in 2017” session.

“Thoracic surgical approaches and techniques are in constant evolution,” said course chair Virginia R. Litle, MD, of the Boston Medical Center. “Less invasive approaches are available for diagnosing and staging thoracic malignancies, for preoperative planning and avoidance, and for management of complications, [so] we will hear from experts in the field about preoperative planning techniques that are increasingly available.”

Managing thoracic tumors will be the focus of a multifaceted course set to take place in Saturday morning’s “General Thoracic Skills: Management of Thoracic Tumors in 2017” session.

“Thoracic surgical approaches and techniques are in constant evolution,” said course chair Virginia R. Litle, MD, of the Boston Medical Center. “Less invasive approaches are available for diagnosing and staging thoracic malignancies, for preoperative planning and avoidance, and for management of complications, [so] we will hear from experts in the field about preoperative planning techniques that are increasingly available.”

The American Society of ExtraCorporeal Technology (AmSECT) is excited to collaborate with AATS for a shared educational program.

Open communication is critical for a high-functioning team, ultimately leading to the best in patient care. During the AmSECT International Conference and AATS Centennial, there will be great opportunities for perfusionists, surgeons, and health care professionals to collaborate, learn together, and make connections. There will be collaborative parallel sessions during the didactic portion of the program on Saturday and Sunday. The combined sessions on Saturday and the Postgraduate Symposia on Sunday include educational content on adult and congenital practice, ethics, transplant and mechanical assist, teamwork, and communication.

[[{"fid":"193783","view_mode":"medstat_image_full_text","attributes":{"height":"73","width":"303","class":"media-element file-medstat-image-full-text","data-delta":"1"},"fields":{"format":"medstat_image_full_text","field_file_image_caption[und][0][value]":"","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_full_text","field_file_image_caption[und][0][value]":"","field_file_image_credit[und][0][value]":""}}}]]AmSECT President Kenny Shann says that AmSECT and the AATS have worked together to eliminate silos of care and bring surgeons and perfusionists together to learn. “We believe that better teams will lead to better outcomes. In my career, learning alongside members of the team, regardless of their specific role, has strengthened my ability to care for patients. Co-learning allows team members to develop a shared mental model and facilitates interdisciplinary communication, which will ultimately result in better patient care.”

Perfusionists: continue the power of collaboration after the Conference by becoming an AmSECT member. In a profession that embraces innovation and ingenuity, our community of connected perfusionists helps you keep up with changing demands and emerging technologies. As a member of AmSECT, you will be supporting efforts to help you do your job better. The AmSECT community focuses on developing practice documents, protocols, best practices, and other value-add guidelines. When the members of AmSECT come together, there is greater potential to meet new opportunities and practice expansions with unbiased results.

Go online to www.amsect.org to learn more and join today.

The American Society of ExtraCorporeal Technology (AmSECT) is excited to collaborate with AATS for a shared educational program.

Open communication is critical for a high-functioning team, ultimately leading to the best in patient care. During the AmSECT International Conference and AATS Centennial, there will be great opportunities for perfusionists, surgeons, and health care professionals to collaborate, learn together, and make connections. There will be collaborative parallel sessions during the didactic portion of the program on Saturday and Sunday. The combined sessions on Saturday and the Postgraduate Symposia on Sunday include educational content on adult and congenital practice, ethics, transplant and mechanical assist, teamwork, and communication.

[[{"fid":"193783","view_mode":"medstat_image_full_text","attributes":{"height":"73","width":"303","class":"media-element file-medstat-image-full-text","data-delta":"1"},"fields":{"format":"medstat_image_full_text","field_file_image_caption[und][0][value]":"","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_full_text","field_file_image_caption[und][0][value]":"","field_file_image_credit[und][0][value]":""}}}]]AmSECT President Kenny Shann says that AmSECT and the AATS have worked together to eliminate silos of care and bring surgeons and perfusionists together to learn. “We believe that better teams will lead to better outcomes. In my career, learning alongside members of the team, regardless of their specific role, has strengthened my ability to care for patients. Co-learning allows team members to develop a shared mental model and facilitates interdisciplinary communication, which will ultimately result in better patient care.”

Perfusionists: continue the power of collaboration after the Conference by becoming an AmSECT member. In a profession that embraces innovation and ingenuity, our community of connected perfusionists helps you keep up with changing demands and emerging technologies. As a member of AmSECT, you will be supporting efforts to help you do your job better. The AmSECT community focuses on developing practice documents, protocols, best practices, and other value-add guidelines. When the members of AmSECT come together, there is greater potential to meet new opportunities and practice expansions with unbiased results.

Go online to www.amsect.org to learn more and join today.

The American Society of ExtraCorporeal Technology (AmSECT) is excited to collaborate with AATS for a shared educational program.

Open communication is critical for a high-functioning team, ultimately leading to the best in patient care. During the AmSECT International Conference and AATS Centennial, there will be great opportunities for perfusionists, surgeons, and health care professionals to collaborate, learn together, and make connections. There will be collaborative parallel sessions during the didactic portion of the program on Saturday and Sunday. The combined sessions on Saturday and the Postgraduate Symposia on Sunday include educational content on adult and congenital practice, ethics, transplant and mechanical assist, teamwork, and communication.

[[{"fid":"193783","view_mode":"medstat_image_full_text","attributes":{"height":"73","width":"303","class":"media-element file-medstat-image-full-text","data-delta":"1"},"fields":{"format":"medstat_image_full_text","field_file_image_caption[und][0][value]":"","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_full_text","field_file_image_caption[und][0][value]":"","field_file_image_credit[und][0][value]":""}}}]]AmSECT President Kenny Shann says that AmSECT and the AATS have worked together to eliminate silos of care and bring surgeons and perfusionists together to learn. “We believe that better teams will lead to better outcomes. In my career, learning alongside members of the team, regardless of their specific role, has strengthened my ability to care for patients. Co-learning allows team members to develop a shared mental model and facilitates interdisciplinary communication, which will ultimately result in better patient care.”

Perfusionists: continue the power of collaboration after the Conference by becoming an AmSECT member. In a profession that embraces innovation and ingenuity, our community of connected perfusionists helps you keep up with changing demands and emerging technologies. As a member of AmSECT, you will be supporting efforts to help you do your job better. The AmSECT community focuses on developing practice documents, protocols, best practices, and other value-add guidelines. When the members of AmSECT come together, there is greater potential to meet new opportunities and practice expansions with unbiased results.

Go online to www.amsect.org to learn more and join today.

You can get the full AATS meeting experience right in the palm of your hand with the AATS Week Mobile App. Available through the iTunes store, Android Market, and AATS website, the app gives you access to every detail of the AATS Mitral Conclave and the AATS Centennial.

• My Schedule and My Notes, which allow you to add your own personalization.
• Complete up-to-date schedule of what is taking place.
• Interactive Exhibit Floor.
• Exhibitors list, with company descriptions, contact information and booth location.
• Floor plans for the New York Hilton Midtown and Boston Hynes Convention Center.
• General meeting information.

You can get the full AATS meeting experience right in the palm of your hand with the AATS Week Mobile App. Available through the iTunes store, Android Market, and AATS website, the app gives you access to every detail of the AATS Mitral Conclave and the AATS Centennial.

• My Schedule and My Notes, which allow you to add your own personalization.
• Complete up-to-date schedule of what is taking place.
• Interactive Exhibit Floor.
• Exhibitors list, with company descriptions, contact information and booth location.
• Floor plans for the New York Hilton Midtown and Boston Hynes Convention Center.
• General meeting information.

You can get the full AATS meeting experience right in the palm of your hand with the AATS Week Mobile App. Available through the iTunes store, Android Market, and AATS website, the app gives you access to every detail of the AATS Mitral Conclave and the AATS Centennial.

• My Schedule and My Notes, which allow you to add your own personalization.
• Complete up-to-date schedule of what is taking place.
• Interactive Exhibit Floor.
• Exhibitors list, with company descriptions, contact information and booth location.
• Floor plans for the New York Hilton Midtown and Boston Hynes Convention Center.
• General meeting information.

Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, Sidhartha R. Sinha, MD, told attendees at last year’s AGA Tech Summit.

Gastroenterologists should get involved in innovation early because there is much to learn, Dr. Sinha of Stanford (Calif.) University advised in this video interview from the meeting. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, he noted.

Innovation in gastroenterology will be front and center again at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, Sidhartha R. Sinha, MD, told attendees at last year’s AGA Tech Summit.

Gastroenterologists should get involved in innovation early because there is much to learn, Dr. Sinha of Stanford (Calif.) University advised in this video interview from the meeting. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, he noted.

Innovation in gastroenterology will be front and center again at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, Sidhartha R. Sinha, MD, told attendees at last year’s AGA Tech Summit.

Gastroenterologists should get involved in innovation early because there is much to learn, Dr. Sinha of Stanford (Calif.) University advised in this video interview from the meeting. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, he noted.

Innovation in gastroenterology will be front and center again at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
 

FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.

[email protected]

On Twitter @EAZTweets

The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
 

FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.

[email protected]

On Twitter @EAZTweets

The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
 

FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.

[email protected]

On Twitter @EAZTweets