Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx – the industry's first and only kitted, pan-solid tumor liquid biopsy test.

Diasorin (FTSE MIB: DIA) today announced that the Food and Drug Administration (FDA) has granted de-novo authorization for the Simplexa® C. auris Direct kit to test patients suspected of Candida auris colonization and aid in preventing potential spread in healthcare settings. This real-time polymerase chain reaction (RT-PCR) assay is used for the direct in vitro qualitative detection of C.auris DNA from a swab of axilla/groin from patients suspected of C. auris colonization, and detects the six C.auris clades that are circulating globally.

Invitae (NYSE: NVTA), a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel.

Renalytix has received De Novo marketing authorisation from the US Food and Drug Administration (FDA) for its KidneyIntelX.dkd prognostic test.

Cue Health, a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.

Qiagen and Denovo Biopharma said on Thursday that they are collaborating to develop a blood-based companion diagnostic test to identify patients expressing a genomic biomarker who are likely to respond to Denovo's investigational DB102 treatment for diffuse large B-cell lymphoma.