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Gail Javitt Quoted in “Labs Mull New Regulatory Path for NGS Tumor Panels in Wake of FDA Decision on MSK-IMPACT”

GenomeWeb

Gail H. Javitt, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in GenomeWeb, in “Labs Mull New Regulatory Path for NGS Tumor Panels in Wake of FDA Decision on MSK-IMPACT,” by Turna Ray.

Following is an excerpt:

The US Food and Drug Administration’s authorization last week of a 468-gene tumor profiling test puts into play several regulatory strategies that the agency has been mulling for some time, but it remains to be seen if other cancer centers and diagnostic companies with similar cancer panels will be willing to pursue the new pathway. …

“As long as there is a parallel LDT pathway, it is unclear to me what the advantage would be to pursuing FDA clearance for a tumor profiling panel,” said Gail Javitt, a lawyer in Epstein Becker Green’s healthcare and life sciences practice. Beyond the considerations of the added time and expense of taking a test through FDA, diagnostics developers are making a “lifetime commitment” in becoming an FDA-regulated manufacturer, she noted, which obligates them to activities far beyond a one-time submission, including registration, inspection, adverse event reporting, and maintaining a quality system. …

“The interpretation of sequencing data is always done in the context of a specific patient, and a variant might be a [Level] 3 for one patient, given the other clinical information, but [Level] 2 for another. It is not a situation in which the clinical community wakes up one morning and says, ‘Time to move variant X from Level 3 to Level 2,’” Javitt reflected. “Given that reality, I guess it is a good thing that a new submission will not be required to move from [Level] 3 to 2, as that would delay a laboratory’s ability to start reporting a new variant as evidence emerges.” …

“It is true that insurers do sometimes look for the imprimatur of FDA review in making coverage decisions, but that is not always the case, and I think would be hard to justify in a context where most panels do not have clearance,” Javitt said. “Ultimately, insurers want to see evidence that performing a test has a meaningful benefit for a patient, [for example for] selecting an effective drug, or avoiding an ineffective drug.”