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News items for the in vitro diagnostics industry for the week of March 23, 2020.
LabCorp's test is being made available pursuant to FDA guidance that allows high-complexity, CLIA-certified labs to perform their own tests for SARS-CoV-2.
The company said clinical services revenues and diagnostic testing volumes rose during the quarter, but that PAMA continued to negatively affect reimbursements.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
The firm also said it is contemplating selling its therapeutics division, and appointed David Bench as its new CFO.
The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.
The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.
The case, which was originally being fought between Enzo and Hologic, was decided in favor of Becton Dickinson, Hologic's co-plaintiff.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.