News and reporting on BRCA biomarkers.
The agency has granted the drug and CDx priority review, which Myriad expects to conclude during its fiscal third-quarter ending March 31, 2018.
The company has made agreements with two cancer diagnostics firms — GenomeDx, and Cynvenio — bundling its hereditary germline analysis with their somatic tests.
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 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).