The group that advises primary care clinicians found evidence that false-positive screening results could lead to surgical interventions in asymptomatic patients.
NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.
The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.
The BRCA Mastr Plus Dx assay and Mastr Reporter software identifies mutations in the coding regions of the BRCA1 and BRCA2 genes
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
They have also developed an exosome-based test for high volume laboratory applications that was recently licensed by Exosome Diagnostics.
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.