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BRCA Biomarkers

News and reporting on BRCA biomarkers.

The first randomized study to show a PARP inhibitor benefits advanced breast cancer patients is also a sign of the expanding utility of BRCA testing in precision medicine.

The test is a targeted next-gen sequencing assay that uses Illumina's MiniSeq, MiSeq, and NextSeq platforms to detect somatic mutations in BRCA1 and BRCA2.

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.

BeiGene will use Myriad's myChoice HRD and BRACAnalysis CDx in the development program for its investigational PARP inhibitor BGB-290.

The test is approved as a tool to identify which patients with a kind of ovarian cancer are likely to benefit most from Tesaro's Zejula (niraparib).

The combination test will allow clinicians to analyze breast cancer patients for germline hereditary cancer markers at the same time as they search their blood for driver mutations.

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.

Invitae will test 1,000 breast cancer patients from TME practices using its hereditary cancer test, regardless of whether they meet current eligibility criteria.

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