Last week, the FDA tried to better define its role in molecular testing. The agency approved Memorial Sloan Kettering’s MSK-IMPACT, which profiles 468 genes to assess solid tumors, as an in vitro diagnostic (IVD). In addition, it elevated the New York State Department of Health as a third-party reviewer for IVDs.
The FDA also established a class II regulatory pathway for genomic tumor profiling, which allows manufacturers to pursue 510(k) clearance, rather than the more rigorous pre-market approval (PMA).
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No one was really surprised by these decisions — the FDA telegraphed some of them in its January 2017 discussion paper. The context goes back to the agency’s 2014 draft guidance, in which it proposed more aggressive regulation for laboratory developed tests (LDTs), angering many in the industry who bridled at adding FDA oversight on top of existing CLIA requirements. The new pathway seems like an attempt to find appropriate middle ground.
“I think they’re peering ahead and saying: ‘How do we manage this and bring some commensurate standards to the field without mandating formal FDA approval for every type of assay?’” said Vince Miller, Foundation Medicine’s chief medical officer, in a phone interview. “LDTs are becoming more important in the cancer genomics space. FDA approval of each one is not plausible, given bandwidth, resources and time.”
Miller and others are wrestling with the impact these new regulatory variables might have on the industry. Will a higher level of approval bring CMS and third-party payers more enthusiastically into the mix? Will it help oncologists incorporate these tests more aggressively into their practice?
“There already are many tests on the market, the question is to what standard are they held?” asks Miller. “Of course, CLIA is the common denominator that folks often refer to. Many people think it’s necessary, but it’s certainly not sufficient. Is the FDA creating a new fundamental distinction, and what are the ramifications of that? If a test is only CLIA approved and didn’t go through the New York State process, let alone the FDA process, what does that mean?”
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Foundation is pursuing parallel review for its FoundationOne CDx test: FDA approval and national coverage determination (NCD) from the Centers for Medicare and Medicaid Services. FoundationOne is designed to assess 324 genes in multiple solid tumors. A determination is expected before the end of the year.
While Miller is uncertain whether FDA approval will motivate third-party payers, he does believe CMS coverage could mobilize interest. On the other hand, FDA approval could be an important milestone for physicians.
“I think getting approval from the FDA takes away some of the physician’s need to take a deep dive,” said Miller. “A doc wants to know that the test he’s ordering has some gold star approval. For the average community doc, who is submerged in the need for rapid knowledge acquisition, this will almost make it simpler.”
Though the FDA pathway is not required, it may end up being quite desirable, offering marketing advantages in an ever-expanding marketplace.
“FDA approval would set a test apart,” said Miller. “CLIA is the floor, New York State is a number of floors above that and the FDA is the penthouse.”
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