Meridian Bioscience said on Tuesday that it has received US Food and Drug Administration clearance for its Premier HpSA Flex assay for the diagnosis of Helicobacter pylori in both preserved and unpreserved stools.

Life sciences proteomics firm Seer on Wednesday announced an expanded collaboration with Thermo Fisher Scientific.

DiaSorin said late Friday that it has nabbed US Food and Drug Administration 510(k) clearance for a molecular assay that differentiates between infections with the SARS-CoV-2 and influenza A and B viruses.

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.