By Kelly A. Briganti, Editorial Director, G2 Intelligence
Next Generation Sequencing (NGS) diagnostic tests bring incredible opportunities for patient care, yet at the same time present significant challenges for oversight. Recognizing these challenges and opportunities, the FDA is seeking public comment on how best to regulate NGS testing. The FDA issued a Discussion Paper exploring these challenges and will hold a day-long public workshop Feb. 20, 2015 titled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests,” to provide a forum for public comment.
The FDA’s discussion paper explains that oversight of NGS testing can be difficult given the ability to sequence the whole genome and the fact that the variant to be identified does not need to be known prior to testing. The FDA acknowledges it is impractical to require accuracy and clinical significance be shown for every possible variant. So it is seeking public comment on the use of subsets of types of variants to demonstrate analytical test performance, a standards-based approach or other methodologies. For evaluating clinical performance of NGS testing, the FDA solicits comment about the use of “highly curated genetic databases that provide information on genetic variants and their association with disease.” Comments should respond to strategies outlined in the discussion paper, which can be accessed at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
Free registration for the FDA’s Feb. 20 workshop closes Feb. 12 for in person attendance at the workshop or to access its webcast, and is first-come, first serve. Written comments can be submitted electronically (to http://www.regulations.gov) or in writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments must be submitted by March 20, 2015. For instructions with regard to submission of written comments, see Dec. 29, 2014 federal register announcing the workshop: http://www.gpo.gov/fdsys/pkg/FR-2014-12-29/pdf/2014-30308.pdf
This very topic will also be the subject of discussion at G2 Intelligence’s live conference, Lab Revolution, at the Loews Portofino Bay Hotel at Universal Orlando,® in a March 12, 2015 presentation titled “Changing the Face of Diagnostics: The Next Generation of Next-Generation Sequencing.”