 and College of American Pathologists (CAP)-certified laboratories.){kind=link}
Danaher Corporation, has announced the establishment of two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified laboratories. These labs are designed to expedite the development and commercialization of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx), crucial tools in the field of precision medicine.
These state-of-the-art labs aim to streamline the traditionally lengthy process of diagnostic development. By consolidating multiple diagnostic technologies and assays under one roof, Danaher seeks to minimize time-consuming procedures and enhance the efficiency of bringing precision treatments to market. This innovative approach is expected to significantly benefit patients by enabling faster access to targeted therapies.
Julie Sawyer Montgomery, Executive Vice President at Danaher, emphasized the strategic importance of these centers. “Our investment in these innovation centers positions Danaher as a pivotal connector within the innovation ecosystem, leveraging diagnostic technology to simplify and speed up pharmaceutical translational research. This initiative has the potential to bring precision treatments to market more swiftly, ultimately benefiting more patients globally.”
Amit Agrawal, Chief Scientific Officer of DH Diagnostics LLC, highlighted the need for a holistic approach in the pharmaceutical industry. “The development of meaningful diagnostics requires minimizing assay format transfers and streamlining processes from biomarker validation to clinical trial assays. Our new approach aims to unlock the full potential of precision medicine, ensuring the right treatment reaches the right patient at the right time.”
CDx tests are designed to determine a patient’s suitability for specific therapies by identifying the presence of particular biomarkers. CoDx tests, on the other hand, broadly indicate which type of therapy might be most beneficial. These diagnostics are particularly vital for cancer patients, where precise treatment can significantly impact outcomes.
The first of Danaher’s new labs will open in Newcastle, UK, serving as a hub for collaborative research with leading pharmaceutical and academic institutions. This lab will be hosted by Leica Biosystems, a Danaher subsidiary, in a new state-of-the-art facility.
A second center is set to open in the United States later this year, featuring a wide range of diagnostic capabilities, including immunohistochemistry (IHC), polymerase chain reaction (PCR), and immunoassay. The lab will be equipped with instrumentation from several Danaher subsidiaries, such as Cepheid, Beckman Coulter Diagnostics, and Leica Biosystems, with plans to incorporate additional technologies in the future.
These new facilities are part of Danaher’s broader strategy to enhance its portfolio of diagnostic tools and improve patient care through innovation and efficiency. By addressing inefficiencies in the clinical care workflow, Danaher aims to facilitate faster commercialization of personalized treatments, ultimately improving patient outcomes.