Roche subsidiary Foundation Medicine announced on Thursday that the US Food and Drug Administration has approved two of its companion diagnostic tests for use with Pfizer's Braftovi (encorafenib) in combination with Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Cell Signaling Technology (CST), a life science discovery technology company and leading provider of antibodies, kits, and services, is partnered with Leica Biosystems, a technology leader in automated staining and brightfield and fluorescent imaging, to support the development of companion diagnostics (CDx) assays using the extensive portfolio of best-in-class antibodies from CST validated for immunohistochemistry (IHC).

Novartis subsidiary Navigate Biopharma announced on Friday that it has formed a strategic collaboration with Becton Dickinson to help develop and commercialize companion diagnostics and clinical decision-making tools using flow cytometry.

Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR).

Not long after acquiring Resolution Bioscience in a deal worth more than half a billion dollars, Agilent Technologies has resolved to shutter the business, which was developing liquid biopsy tests that were powered by next-generation sequencing technology and meant to be used as companion diagnostics for cancer patients.

Roche subsidiary Foundation Medicine announced on Monday that its FoundationOne CDx test received approval from the US Food and Drug Administration for use as a companion diagnostic for Janssen Biotech's Akeega (niraparib and abiraterone acetate).

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit).

Amoy Diagnostics Co., Ltd (AmoyDx), a China-based innovative molecular diagnostics company, announced that it has entered into a Companion Diagnostic Collaboration Agreement with AstraZeneca, a global biopharmaceutical company.