ARTICLE | Strategy
Next generation resolutions
Charting FDA’s recent progress and ongoing campaigns in NGS diagnostics
January 4, 2018 10:30 PM UTC
With a slew of landmark approvals in the last 18 months, FDA has solidified its commitment to advancing genetic diagnostics. Now the agency is turning to the outstanding challenges, with solutions on the horizon for software variability across NGS systems, limitations of liquid biopsies and detection of low-frequency variants.
In the last year and a half, FDA has approved five next-generation sequencing (NGS)-based tests -- all of which look for cancer-associated mutations in multigene panels -- and the first liquid biopsy diagnostic of cell-free DNA (cfDNA) in the blood: a PCR-based test for specific EGFR mutations. ...