Original from: Danaher Corporation
¡¤ DH Diagnostics LLC Centers aim to accelerate drug development by speeding and streamlining development and commercialization of companion diagnostics.
¡¤ Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified laboratories will bring technologies and assays from multiple Danaher subsidiaries together under a single roof.
Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, announced the launch of two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified labs intended to accelerate the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx).
"Our investments in these centers of innovation uniquely position Danaher as a global connector across the innovation ecosystem, leveraging diagnostic technology to simplify and speed pharma translational research," said Julie Sawyer Montgomery, Executive Vice President at Danaher. "I am excited about this new way of potentially enabling our partners to more quickly bring precision treatments to market ¨C ultimately benefiting more patients everywhere."
"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," said Amit Agrawal, Chief Scientific Officer, DH Diagnostics LLC. "I believe our new approach to catalyzing development of meaningful diagnostics has the potential to bring us significantly closer to realizing the potential of precision medicine to deliver the right medicine for the right patient at the right time."
CDx and CoDx tests enable patients to receive targeted therapies intended 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.
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 centers of innovation 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, scheduled to open in July in Newcastle, UK, will serve as a hub for collaborative research with leading 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, located in the United States, 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.
