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In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
The analysis suggested CDK7 inhibitors could boost the sensitivity of tumor cells capable of homologous recombination to PARP inhibitor treatment.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
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.
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.
The company will test samples from women treated with an investigational combination of AstraZeneca's PARP inhibitor olaparib and immunotherapy tremelimumab.
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 Washington Post reports that Herbert Tabor, who worked at the US National Institutes of Health for 77 years, has died at 101.
The World Bank is seeking approval for a $12 billion plan to provide low-income nations with funds to procure SARS-CoV-2 vaccines, according to Reuters.
Science writes that public health officials and others are debating whether cycle threshold values should be included on SARS-CoV-2 results.
In Nucleic Acids Research this week: online database of SARS-CoV-2 protein structures, atlas of the human brain, and more.