A test that can quickly detect cancer-causing mutations in 324 genes has gained approval from the Food and Drug Administration (FDA) and a green light for coverage from the Center for Medicare and Medicaid Services (CMS).
Developed by Foundation Medicine and known as FoundationOne CDx (F1CDx), the test is meant to help doctors tailor treatments to specific mutations driving a patient’s cancer. It identifies substitutions, insertions, and deletions in the genetic alphabet that provides instructions for cells to work normally. The test is accurate approximately 94.6 percent of the time, according to the company. It is the first ever FDA-approved comprehensive companion diagnostic for multiple types of cancer — including certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, and breast cancer.
It is also only the second diagnostic test to win concurrent approval from both the FDA and CMS under a parallel review program that was introduced in 2011. The first was a non-invasive DNA screening test for colon cancer that allowed patients to check for the presence of red blood cells and DNA mutations in stool samples from the privacy of their own homes.
“Through parallel review and collaboration, we speed access to innovative diagnostics, so that doctors are better able to deliver the best quality care to their patients, and patients have access to these state-of-the-art tests,” Seema Verma, Administrator of CMS said in a statement.
Although insurance coverage of similar tests has been inconsistent in the past, Medicare’s endorsement of the test may set an important precedent for private insurers.
The FoundationOne test also provides information on which patients may respond well to targeted therapies. That includes immunotherapy drugs like Keytruda, which received FDA approval in May for use in patients whose tumors carry a specific glitch, regardless of where in the body the tumor is located.
Experts disagree over the extent to which genetic profiling of tumors can be helpful in matching patients to treatments and clinical trials. But the predictive ability of such genetic screens may be especially valuable in the case of expensive drugs like Keytruda (which costs about $150,000 for a full-year of treatment for one patient).
Additionally, by providing all of this information in one report, the FoundationOne test avoids the need for separate tumor biopsies for each single-gene test. And the test makers hope that healthcare professionals will use it to expand their cancer care toolkit. “Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” Troy Cox, chief executive officer at Foundation Medicine said in a company statement.
“Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care,” Cox said.