Bethany Hills Quoted in “FDA’s Proposed LDT Model Would Hinder Next-Gen DNA Tests, Cancer Expert Says”Bloomberg BNA Medical Devices Law & Industry Report February 3, 2016
Bethany J. Hills, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s New York office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA’s Proposed LDT Model Would Hinder Next-Gen DNA Tests, Cancer Expert Says.”
Following is an excerpt:
As the industry awaits final FDA action on the LDT guidance, ‘‘we can’t help but look to’’ the agency’s proposed framework as an indicator of how it may approach next-generation sequencing (NGS), said attorney Bethany Hills, of Epstein Becker and Green PC in New York, who moderated the NYSBA session.
‘‘We are encouraged that FDA appears to be approaching NGS as unique, and somewhat differently, raising the question of whether FDA’s final actions on LDTs generally may be potentially more relaxed than the proposed guidance,’’ she told Bloomberg BNA after the session.