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.
BeiGene will use Myriad's myChoice HRD and BRACAnalysis CDx in the development program for its investigational PARP inhibitor BGB-290.
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.
Progression-free and overall survival seen in the veliparib arm weren't statistically significant, but were encouraging enough to move the drug to Phase III, AbbVie said.
Multiple variant databases are creating competition among groups that disagree on how to advance the most scientifically robust and sustainable sharing model.
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.
Although Tesaro used Myriad's BRCA and HRD tests to stratify patients, in the NOVA trial all recurrent ovarian cancer patients benefitted from niraparib.