Danaher Announces Two New Centers of Innovation in Diagnostics to Transform Precision Medicine Development

• 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.

WASHINGTON, July 17, 2024 /PRNewswire/ -- 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 – 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.

*CAP CLIA certifications pending

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.

FORWARD-LOOKING STATEMENTS
Statements in this release that are not strictly historical, including any statements regarding events or developments that we believe or anticipate will or may occur in the future are "forward-looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause actual results, developments and business decisions to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. Information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in our SEC filings, including our 2023 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the first quarter of 2024. These forward-looking statements speak only as of the date of this release and except to the extent required by applicable law, Danaher does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise.

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