BioCentury
ARTICLE | Translation in Brief

Next-generation growth spurt

New NGS methods only partially benefit from recent FDA approvals

August 18, 2017 12:18 AM UTC

A milestone FDA approval could signal next-generation sequencing tests are on the verge of becoming established players in cancer diagnostics. A series of papers published this week highlights further advances in NGS technology, but the differences from the approved methods mean companies will still need to break new ground with regulators.

In June, FDA approved Thermo Fisher Scientific Inc. (NYSE:TMO)'s Oncomine Dx Target Test, a 23-gene targeted sequencing panel for tumor samples, as a companion diagnostic for three drugs approved to treat non-small cell lung cancer (NSCLC) in specific patient populations. The approval allows the company to sell kits of its test to hospitals and other laboratories throughout the country...