Danaher Corporation today launched two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) certified labs to accelerate the development of companion diagnostics (CDx) and complementary diagnostics (CoDx).
CDx and CoDx tests enable patients to receive targeted therapies to better treat their disease. CDx tests are designed to determine whether a patient produces enough of a particular protein to respond well to a specific drug. CoDx tests highlight broadly which type of therapy may be most helpful to a patient. For patients undergoing cancer treatment, this diagnostic process can make a significant difference in prognosis.
The DH Diagnostics LLC Centers aim to speed and streamline the development and commercialization of companion diagnostics.
According to Amit Agrawal, chief scientific officer of DH Diagnostics, the pharmaceutical industry needs a new, holistic approach that minimizes time-consuming assay format transfers and contracts across every step, from biomarker validation to clinical trial assays and companion and complementary diagnostics to global deployment, education, and adoption. Agrawal believes this new approach to catalyzing the development of meaningful diagnostics can bring the company significantly closer to realizing the potential of precision medicine to deliver the right medicine for the right patient at the right time.
Today, the development process for CDx and CoDx from discovery to FDA approval can be lengthy, requiring an average of 15 hand-offs as studies move from research-grade to clinical. Danaher's innovation centers will seek to drive efficiencies within this ecosystem by minimizing hand-offs and bringing multi-modal capabilities under one roof.
Danaher's installed base of instruments in more than 30,000 hospitals in 120 countries offers the potential to further facilitate faster commercialization of personalized treatment for patients.
Danaher's first CLIA CAP lab (certifications pending) is scheduled to open this month in Newcastle, UK. The lab will be a hub for collaborative research with pharmaceutical and academic institutions. Leica Biosystems, a global leader in anatomic pathology and a Danaher subsidiary, is hosting the lab in a state-of-the-art new building on its campus.
In parallel, Danaher's additional center of innovation in the U.S. is scheduled to open its doors later this year and include capabilities such as immunohistochemistry (IHC), polymerase chain reaction (PCR) and immunoassay.
Instrumentation from several Danaher subsidiaries, including Cepheid, Beckman Coulter Diagnostics, and Leica Biosystems, will be available in this lab, with additional capabilities from other subsidiaries to join in the future. Further modalities, such as next-generation sequencing (NGS), are available via Danaher's subsidiaries and strategic partners.
