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Danaher Corporation, a global leader in science and technology innovation, has announced the launch of two cutting-edge Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified laboratories. These labs are designed to accelerate the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx), aiming to transform precision medicine by streamlining the development and commercialization process.
Accelerating Precision Medicine
The new laboratories will consolidate advanced technologies and assays from multiple Danaher subsidiaries, including Leica Biosystems, Cepheid, and Beckman Coulter Diagnostics, under one roof. This strategic integration aims to minimize the traditionally time-consuming steps involved in diagnostic development, from biomarker validation to clinical trial assays, and eventually, to global deployment and adoption.
Julie Sawyer Montgomery, Executive Vice President at Danaher, expressed enthusiasm about the new centers, stating, “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. I am excited about this new way of potentially enabling our partners to more quickly bring precision treatments to market – ultimately benefiting more patients everywhere.”
A Holistic Approach to Diagnostics
Amit Agrawal, Chief Scientific Officer at DH Diagnostics LLC, emphasized the need for a holistic approach in the pharmaceutical industry. “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,” he said. “I believe our new approach to catalyzing the 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.”
Impact on Patient Care
CDx and CoDx tests are crucial in the realm of precision medicine. CDx tests help determine if a patient produces enough of a specific protein to respond effectively to a particular drug, while CoDx tests identify the most suitable type of therapy for a patient. This targeted approach is particularly significant for cancer patients, as it can significantly improve their prognosis by tailoring treatments to their unique genetic makeup.
Global Reach and Collaborative Research
The first CLIA CAP lab is set to open this month in Newcastle, UK, within a state-of-the-art building on Leica Biosystems’ campus. This lab will serve as a hub for collaborative research with leading pharmaceutical and academic institutions. The second center, located in the United States, is expected to open later this year, offering capabilities such as immunohistochemistry (IHC), polymerase chain reaction (PCR), and immunoassay. The inclusion of instrumentation from several Danaher subsidiaries and future additions like next-generation sequencing (NGS) ensures a comprehensive and advanced diagnostic offering.
Danaher’s extensive installed base of instruments in over 30,000 hospitals across 120 countries positions the company to facilitate faster commercialization of personalized treatments, ultimately enhancing patient care on a global scale.
Danaher’s new centers of innovation represent a significant step forward in the field of precision medicine. By reducing the complexity and time involved in developing and commercializing companion and complementary diagnostics, these centers are poised to revolutionize the way targeted therapies are brought to market, benefiting patients worldwide.
About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Our businesses partner closely with customers to solve many of the most important health challenges impacting patients around the world. Danaher’s advanced science and technology – and proven ability to innovate – help enable faster, more accurate diagnoses and help reduce the time and cost needed to sustainably discover, develop and deliver life-changing therapies. Focused on scientific excellence, innovation and continuous improvement, our approximately 63,000 associates worldwide help ensure that Danaher is improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. Explore more at www.danaher.com.
