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The Enzo and Access Bio tests may be performed by any CLIA-certified high complexity lab, while use of Gene By Gene's test is limited to its developer.
News items for the in vitro diagnostics industry for the week of June 29, 2020.
The company said clinical services revenues and diagnostic testing volumes fell during the quarter due to the negative impact of the COVID-19 pandemic.
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.