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Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
The partners will extend the lung cancer biomarker study to countries in and outside Europe, and see if liquid biopsy could offer benefits to tissue-based testing.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.