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News and reporting on ovarian cancer.
The BRCA Mastr Plus Dx assay and Mastr Reporter software identifies mutations in the coding regions of the BRCA1 and BRCA2 genes
The company plans to submit a package to the FDA by the end of this year for use of the system in metastatic breast cancer patients, and then add other cancer types in the future.
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.
Myriad filed the first PMA module with the FDA, though based on the agency's feedback it's unclear whether it will view myChoice HRD as a companion or complementary test.
The study showed an overall benefit regardless of BRCA mutation or HRD status, but some analysts believe the FDA still might require a CDx for niraparib.