Danaher Announces Two New Centers of Innovation in Diagnostics to Transform Precision Medicine Development
Danaher (NYSE: DHR) has announced the launch of two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified labs aimed at accelerating the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx). These centers of innovation are designed to streamline the development and commercialization of precision medicine.
The first lab, opening in Newcastle, UK in July, will serve as a hub for collaborative research with pharmaceutical and academic institutions. A second center in the United States is scheduled to open later this year, featuring capabilities such as immunohistochemistry, PCR, and immunoassay. These labs aim to minimize hand-offs in the diagnostic development process, potentially reducing the time from discovery to FDA approval for CDx and CoDx tests.
- Launch of two new CLIA and CAP-certified labs to accelerate CDx and CoDx development
- Potential to streamline and speed up precision medicine development process
- Collaboration opportunities with leading pharmaceutical and academic institutions
- Access to Danaher's installed base of instruments in 30,000+ hospitals across 120 countries
- Integration of technologies from multiple Danaher subsidiaries under one roof
- None.
Insights
The establishment of these new CLIA and CAP-certified labs by Danaher marks a significant advancement in the realm of precision medicine. By consolidating multiple diagnostic technologies under one roof, Danaher aims to streamline the typically fragmented process of developing Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx). This move is poised to reduce the average 15 hand-offs that occur throughout the process, thereby potentially speeding up the time it takes for new therapies to reach the market.
From a medical research perspective, this initiative could substantially enhance the efficiency of biomarker validation and clinical trial assays. It would allow for quicker iteration and validation of assays, which is critical in the fast-paced field of drug development. Additionally, having access to advanced technologies like immunohistochemistry (IHC), polymerase chain reaction (PCR) and next-generation sequencing (NGS) within a single facility can foster more robust and integrated research efforts.
This consolidation can lead to more accurate and timely diagnostics, ultimately benefiting patients by facilitating the quicker delivery of targeted therapies. However, the challenge will be ensuring that these centers can effectively manage the scale of operations while maintaining the high standards required for CLIA and CAP certifications.
From a market standpoint, Danaher's new centers could significantly influence the pharmaceutical and diagnostics market. The ability to streamline the development and commercialization of CDx and CoDx could give Danaher a competitive edge in the rapidly growing field of precision medicine. With an installed base in over 30,000 hospitals across 120 countries, Danaher is well-positioned to leverage its existing network to expedite the adoption of these advanced diagnostics.
By minimizing the time-consuming assay format transfers and contracts typically needed at every development step, Danaher could lower both the time and cost associated with bringing new diagnostics to market. This may appeal to pharmaceutical companies looking to partner with Danaher for its efficiency and comprehensive diagnostic solutions.
However, the real test will be in execution. The successful operation of these centers will be critical in determining their true impact on the market. Any delays or issues in obtaining the necessary CAP and CLIA certifications could impede the anticipated benefits and affect investor confidence.
From a financial perspective, this initiative by Danaher represents a strategic investment in the future of precision medicine. The potential to reduce development times and costs for companion and complementary diagnostics could lead to significant long-term revenue growth. Moreover, the integration of technologies from various Danaher subsidiaries is likely to enhance operational synergies, contributing to improved financial performance.
This move can be seen as part of a broader strategy to capitalize on the increasing demand for targeted therapies, particularly in oncology. Given the company's extensive installed base and strong market presence, these new centers could drive increased utilization of Danaher's products and services across the pharmaceutical and healthcare sectors.
In the short term, investors should monitor the progress of the labs' construction and the acquisition of necessary certifications. Any delays or unforeseen costs could impact short-term financial performance. However, the long-term outlook remains positive, with substantial potential for growth in the precision medicine market.
- 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.
"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
In parallel, Danaher's additional center of innovation, located in
*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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SOURCE Danaher Corporation
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