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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.
News items for the in vitro diagnostics industry for the week of July 6, 2020
Of the 28 companies in the index, 21 firms saw their stock prices increase throughout the first half of the year, while seven firms' share prices decreased.
Of the 28 companies in the index, 18 firms saw their stock prices increase, while 10 firms' share prices decreased.
News items for the in vitro diagnostics industry for the week of June 15, 2020.
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.
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.