QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).
Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients.
The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.
Biocartis said Thursday that it has secured US Food and Drug Administration 510(k) clearance for a microsatellite instability (MSI) assay to screen for Lynch syndrome in colorectal cancer patients.
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