Gail Javitt Quoted in “FDA Propels Next-Gen Sequencing”

POLITICO Morning eHealth

Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in POLITICO Morning eHealth, in “FDA Propels Next-Gen Sequencing,” by Arthur Allen.

Following is an excerpt:

The Food and Drug Administration’s new guidance on genetic sequencing — used to diagnose hereditary conditions and inform treatment — could streamline the approval process for developers, Epstein, Becker and Green’s Gail Javitt tells Morning eHealth.

— The two pieces of guidance walk test makers through the process of developing and validating their products. They also alert the developers to FDA-recognized databases containing information about genetic variants, which can be used to assess their validity.

— Javitt says the guidance isn’t likely to be controversial because “FDA has been relatively cautious and thoughtful in the way it has approached next-gen sequencing.”

— What might cause a stir is the discussion of who pays for these tests, she said. CMS has said it would not cover laboratory-developed sequencing-based cancer screenings -- an analysis conducted in a single laboratory. But it says it will pay for screenings that are used in conjunction with FDA-approved companion diagnostics, which are subject to more stringent requirements and are designed to assess how a patient might respond to treatment.