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Under the LCD, pharmacogenomic tests are covered when medications are being considered for use that are known to have a clinically actionable gene-drug interaction.
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.
Breast cancer risk in carriers of pathogenic CHEK2 variants may be classified as low, moderate, or high by adding in polygenic risk score and family history data.
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.
Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.
Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.
Science reports that a Dutch research funding agency is combating a ransomware attack.
In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.