The U.S. Food and Drug Administration approved FoundationOne Liquid CDx, a new pan-tumor liquid biopsy test that is indicated for use as a companion diagnostic for four FDA-approved precision therapies.
Thermo Fisher Scientific and Daiichi Sankyo have partnered to co-develop a companion diagnostic device for patients who have non-small cell lung cancer (NSCLC).
Thermo Fisher Scientific inked a deal with Janssen Biotech, part of Johnson & Johnson, to co-develop a companion diagnostic for cancer. The diagnostic test will support global clinical trial enrollment.
Illumina Inc. and Qiagen N.V. announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.
Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.
A recent report written by SVB Leerink analysts that looked at eight companies and their research-and-development portfolios found that in the past five years, they progressed only 24 percent of their new molecular entities to approval.
Five Prime Therapeutics announced a collaboration with Roche to develop immunohistochemistry companion diagnostic assays for use with the clinical-stage biotechnology company’s first-in-class investigational drug candidates: the anti-FGFR2b antibody bemarituzumab (also known as FPA144) and the a B7-H4 antibody FPA150.
Foundation Medicine Inc. announced a collaboration with Merck & Co. to develop companion diagnostic tests for use with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability high or mismatch repair deficient solid tumors.
ProMIS Neurosciences Inc., a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, announced it has issued a new scientific white paper entitled: ‘Not all Amyloid Beta Therapeutics are Created Equal’.
Roche announced U.S. FDA approval of the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug Zykadia (ceritinib). The Ventana ALK (D5F3) Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for Zykadia.