- In November 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to include biliary tract cancer (BTC). This makes it the first and only FDA-approved companion diagnostic to assess HER2-positive status, helping identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals' ZIIHERA.
- In June 2024, Illumina Inc. introduced DRAGEN v4.3, the newest version of its DRAGEN software, which is part of the Illumina Connected Software portfolio for analyzing next-generation sequencing data. DRAGEN v4.3 incorporates a range of cutting-edge innovations that enable a more comprehensive genome analysis, including support for next-generation multigenome with 128 samples, machine learning mosaic mode, and additional features.
- In July 2024, Danaher Corporation unveiled the opening of two new CLIA and CAP-certified laboratories designed to expedite the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx). These diagnostic tests help ensure patients receive targeted therapies, enhancing the effectiveness of their disease treatment.
- In March 2024, Centogene N.V. announced the expansion of its ongoing partnership with Takeda to improve the diagnosis of patients with Lysosomal Storage Disorders (LSDs). The extended agreement aims to increase patient access to fast and accurate diagnostics for LSDs, including Fabry disease, Gaucher disease, and Hunter syndrome.
- In February 2024, Danaher Corporation entered into a strategic partnership with Cincinnati Children's Hospital Medical Center, aiming to enhance patient safety by tackling a major cause of failure in clinical trials. This collaboration, part of the Danaher Beacons program, focuses on advancing liver organoid technology as a drug toxicity screening solution to protect patients. The initiative has the potential to accelerate the development of new therapies and could save billions of dollars annually in lost research and development productivity.
