The group that advises primary care clinicians found evidence that false-positive screening results could lead to surgical interventions in asymptomatic patients.
A pair of studies indicate the test could aid monitoring of high-risk patients, though concerns voiced by the FDA and others are still to be fully addressed.
The company said investors have agreed to purchase $5.6 million of common stock as well as warrants that, if exercised, could raise an additional $5.1 million.
FDA clearance of the first NGS companion diagnostic paves the way for other comprehensive genomic profiling tests, but Foundation will have to educate docs on the benefits of its test.
The test is approved to identify patients who harbor BRCA mutations and are therefore more likely to respond to Clovis Oncology's ovarian cancer drug Rubraca.
