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In January a federal court unsealed a False Claims Act suit from an industry insider that alleges a Myriad subsidiary engaged in a fraudulent kickback scheme.
The decision comes after Myriad requested expanded coverage for women with breast cancer seeking information about extending endocrine therapy.
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.
The firm reported total revenues of $164 million, which was below the consensus Wall Street estimate of $167.2 million.
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
The available data suggests PGx may be useful in managing medications for COVID-19 patients and in helping people struggling with the mental health impact of the pandemic.
Starting late March and into its fiscal fourth quarter, social distancing guidelines began significantly impacting test volume trends, the company said.
The diagnostic will be covered when patients are tested according to the Japanese Organization of Hereditary Breast and Ovarian Cancer's criteria.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.