Spilling the (LD)T?


When the FDA approved the authorization and a new approval mechanism of the sophisticated cancer screening test developed by researchers at Memorial Sloan Kettering Cancer Center, I immediately wondered what this would mean to the agency’s oversight of next-generation sequencing.

You see, the test, called MSK-IMPACT, uses next-generation sequencing to analyze hundreds of cancer genes and determine quickly whether a patient’s tumor carries clinically useful mutations. This screening also allows them to match individual patients with available therapies or clinical trials that will most benefit them.

Pretty neat, right? But the thing is, the Food and Drug Administration hasn’t finalized how it’s going to regulate these advanced in vitro diagnostics because the proposal released last year for next-generation sequencing is still in draft form.

It turns out I was asking the wrong question.

But at least I was asking the right people.

“This is really a clever sleight-of-hand in a way,” Carol Pratt, one of our board members, an FDA regulatory attorney with Lee & Hayes told me. “It appears that the FDA is announcing a new, low-burden regulatory pathway for IVD devices, when it is really about a voluntary ‘authorization’ process for LDTs.”

LDTs are laboratory-developed tests, which most next-generation sequence diagnostics are. There was so much discord over whether and how the FDA should regulate these diagnostics that the FDA pulled its proposed plan a year ago to give the incoming White House an opportunity to ponder it.

Jennifer Dickey, director of regulatory and quality for Personal Genome Diagnostics, told me, “FDA appears to be establishing a pathway to encourage developers of NGS-based LDTs serving oncology patients to submit their tests to be cleared for marketing.” Before joining the private sector, she worked at the FDA as a senior scientific reviewer in the molecular genetics branch of the agency’s office of in vitro diagnostics and radiological health.

Gail H. Javitt, an attorney with Epstein Becker Green in Washington who has published several scholarly articles on the regulation of NGS, told me the announcement raises a lot of questions, including what this means for LDTs. “FDA is currently exercising enforcement discretion over laboratory-developed tests. And yet FDA just cleared a laboratory-developed test for cancer.”

Javitt called me from the Personalized Medicine Coalition’s conference in Boston, where these same issues came up. My colleague Adrianne Appel, who covered the conference, reported the FDA will soon launch a program for certifying laboratories that develop diagnostic tests, in lieu of drafting rules for the tests themselves, an official said.

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