Gail Javitt Quoted in “Did FDA Create a Way Forward for Lab-Developed Tests?”

Bloomberg BNA Medical Devices Law & Industry Report

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 Medical Devices Law & Industry Report, in “Did FDA Create a Way Forward for Lab-Developed Tests?” by Jeannie Baumann. (Read the full version – subscription required.)

Following is an excerpt:

Recent FDA authorization of a test to screen for tumors using sophisticated genetic sequencing techniques may provide critical insight on how the agency will treat laboratory-developed tests. …

Gail H. Javitt, an attorney with Epstein Becker Green in Washington who has published several scholarly articles on the regulation of NGS, said it remains unclear how the announcement fits into a broader framework of regulating the use of genomics and clinical care. She also said it raises questions about 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 said in a Nov. 16 interview. …

“We are really just at the beginning of understanding how to integrate next gen sequencing and whole genome sequencing into clinical practice,” Javitt said.