Oncology community scrutinizing obstacles to personalized medicine

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault