Gail Javitt Quoted in “Spilling the (LD)T?”

Bloomberg BNA Health Care Blog

Gail H. Javitt, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in the Bloomberg BNA Health Care Blog, in “Spilling the (LD)T?” by Jeannie Baumann.

Following is an excerpt:

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. …

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.