Roche subsidiary Foundation Medicine said on Monday that its FoundationOne Liquid CDx assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Merck KGaA's Tepmetko (tepotinib) in patients with non-small cell lung cancer.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

Foundation Medicine, Inc., and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC).

Thermo Fisher Scientific and Boehringer Ingelheim said on Thursday that they have partnered to develop companion diagnostic tests to help identify patients with non-small cell lung cancer (NSCLC) with specific mutations who may benefit from emerging targeted therapies.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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.

ChromaCode on Thursday announced a partnership with cancer diagnostic laboratory Protean BioDiagnostics to launch a test for non-small cell lung cancer through an early access program.

Tempus, a leader in artificial intelligence and precision medicine, announces its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery.

The US Food and Drug Administration (FDA) has granted approval for Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic for Takeda’s Exkivity (mobocertinib).

REarranged during Transfection (RET) gene fusion is one of the common oncogenic variants in non-small cell lung cancers (NSCLCs). However, few RET fusion-positive cases have partner intergenic-breakpoint fusions, in which the partner breakpoint localizes to intergenic regions.