- 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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SOURCE Danaher Corporation