Siemens Healthineers said Friday that it has received US Food and Drug Administration 510(k) marketing clearance for the use of its antithrombin activity assay as a companion diagnostic for Sanofi's Qfitlia (fitusiran), which was approved as a routine prophylaxis to prevent bleeding episodes in hemophilia patients.

Foundation Medicine, Inc., a genomics company committed to transforming cancer care, today announced a collaboration with Sumitomo Pharma America, Inc. (SMPA) to develop the FoundationOne®Heme platform as a companion diagnostic to identify patients with acute leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia (MLL) rearrangement, or NPM1 mutations for potential treatment with SMPA’s enzomenib (DSP-5336), an investigational menin inhibitor.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU®. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

In 2019, the BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing) of Xiamen Amoy Diagnostics Co., Ltd. was approved.

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 Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a collaboration with Boehringer Ingelheim to pursue the regulatory approval and commercialization of the Guardant360® CDx liquid biopsy as a companion diagnostic (CDx) for zongertinib, an investigational covalent tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC).

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). 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) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

With a large number of tumor-targeted drugs on the market, companion diagnosis is increasingly used in the process of tumor treatment. The results of using tissue samples for tumor companion diagnosis are more accurate than selecting plasma-free DNA (cell-free DNA, cfDNA).

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* test. This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals' ZIIHERA® (zanidatamab-hrii).

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.