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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.
The company's patent related to labeled nucleotides for use as diagnostic tools and as therapeutic agents has been invalidated.
The company's clinical services revenues were down 34 percent year over year while product revenues ticked up 7 percent.
President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.
A study of Great Danes homes in on a genomic region linked to fearfulness.
CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.
In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.