Primary study sites Baylor Scott & White
Health in Texas and Endeavor Health in Illinois aim to enroll up to
25,000 patients from diverse backgrounds, assessing the impact of
MCED testing on clinical care
Falcon Registry study is another step in Exact
Sciences’ rigorous approach to develop its future multi-biomarker
class blood-based MCED test
Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of
cancer screening and diagnostic tests, today announced that the
first patient has joined its Multi-Cancer Early Detection (MCED)
Falcon Registry Real-World Evidence (RWE) study at Baylor Scott
& White, the primary study site and largest not-for-profit
health system in Texas. The multi-site study will enroll up to
25,000 patients, evaluating the clinical performance, patient and
provider experience, and psychological impact of MCED testing over
a five-year period. Endeavor Health, a Chicago-area health system
serving more than 1.4 million patients, will start enrolling
patients this fall. The U.S. Food and Drug Administration (FDA)
recently authorized an investigational device exemption (IDE) for
the Exact Sciences MCED test, allowing its use in the Falcon
Registry. This study will provide valuable insight to further
inform the development and commercialization of the company’s
future MCED test and support discussions with regulatory agencies,
payers, and guideline bodies.
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“Exact Sciences is dedicated to advancing an MCED test, as it
offers a highly promising way to make an impact on the burden of
cancer,” said Tom Beer, M.D., chief medical officer and vice
president, multi-cancer early detection, Exact Sciences. “Too
often, cancers go undetected until symptoms appear, resulting in
diagnoses at advanced, less treatable stages. Early detection
through screening improves outcomes, yet two-thirds of cancer cases
and deaths are due to cancers that do not have recommended
screening options.1 Our collaboration with Baylor Scott & White
and Endeavor Health is a crucial step forward and represents a
tremendous opportunity to help transform cancer care.”
To better understand the impact of MCED testing on patient care,
the study will use a registry approach, tracking patient data over
time to evaluate outcomes and improve future treatments. Up to
25,000 patients ages 50-80 with no history of cancer will
participate in annual MCED testing for three years and two
additional years of follow-up data collection. Data will also be
collected for a comparator cohort of up to 50,000 patients,
demographically and clinically similar to the study cohort but
receiving standard care without the MCED test. The Exact Sciences
MCED test features two high-performing biomarker classes known for
their ability to identify cancer early, offering sensitivity and
specificity that can detect aggressive cancers and those lacking
current standard of care screening.2
“With this important work, we aim to intercept cancer earlier
than ever before,” said Ronan Kelly, M.D., principal investigator
of the MCED Falcon Registry Real-World Evidence study. Dr. Kelly is
the director of oncology, Baylor Scott & White Charles A.
Sammons Cancer Center at Baylor University Medical Center — Dallas,
and chief of oncology, North Texas Division, Baylor Scott &
White Health. “We are eager to do our part in the national effort
to decrease cancer mortality by 50% over the next 25 years, as
outlined in the U.S. government’s Cancer Moonshot initiative. This
important study is helping advance proactive cancer detection
efforts, and we are excited to help close gaps in existing cancer
screening programs.”
Cancer remains the second leading cause of death in the United
States, with over 2 million new cases and approximately 611,000
deaths projected for 2024.3 Advancing early detection through
innovative approaches like MCED testing has never been more
critical. Baylor Scott & White and Endeavor Health, located in
distinct parts of the country and serving a diverse range of
communities, will help reach a broad representative group of
Americans and provide insights on the potential benefits of early
detection across diverse populations.
“Implementing MCED testing and advancing preventative genomics
are crucial steps in addressing the ‘last mile’ problem in health
care,” said Peter Hulick, M.D., the Janardan D. Khandekar, M.D.,
chair of personalized medicine and the director of the Mark R.
Neaman Center for Personalized Medicine at Endeavor Health. “The
Falcon Registry is a pivotal research study to meet the real-world
challenges of implementation and aligns with the broader vision of
the Davis Family Center for Preventive Genomics at Endeavor Health,
which is to assist patients, their families, and caregivers in
making better-informed decisions about early diagnosis, prevention
strategies, and personalized treatment options.”
The Exact Sciences MCED test is available to patients who have
consented and enrolled in the Falcon Registry study. It has not
been cleared or approved by the U.S. Food and Drug Administration
or other notified regulatory authority. The test was developed and
its performance characteristics validated by Exact Sciences
Laboratories following College of American Pathologists (CAP) and
Clinical Laboratory Improvement Amendments (CLIA) regulations. The
test is performed at Exact Sciences Laboratories. Exact Sciences
Laboratories is accredited by CAP, certified under CLIA
regulations, and qualified to perform high-complexity clinical
laboratory testing.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests,
Exact Sciences gives patients and health care professionals the
clarity needed to take life-changing action earlier. Building on
the success of the Cologuard® and Oncotype® tests, Exact Sciences
is investing in its pipeline to develop innovative solutions for
use before, during, and after a cancer diagnosis. For more
information, visit ExactSciences.com, follow Exact Sciences on X
(formerly known as Twitter) @ExactSciences, or find Exact Sciences
on LinkedIn and Facebook.
About Baylor Scott & White Health
As the largest not-for-profit health system in the state of
Texas, Baylor Scott & White promotes the health and well-being
of every individual, family and community it serves. It is
committed to making quality care more accessible, convenient and
affordable through its integrated delivery network, which includes
the Baylor Scott & White Health Plan, Baylor Scott & White
Research Institute, the Baylor Scott & White Quality Alliance
and its leading digital health platform – MyBSWHealth. Through 51
hospitals and more than 1,200 access points, including flagship
academic medical centers in Dallas, Fort Worth and Temple, the
system offers the full continuum of care, from primary to
award-winning specialty care. Founded as a Christian ministry of
healing more than a century ago, Baylor Scott & White today
serves more than three million Texans. For more information, visit
BSWHealth.com.
About Endeavor Health
Endeavor Health℠ is a Chicagoland-based integrated health system
driven by the mission to help everyone in their communities be
their best. Illinois' third-largest health system and third-largest
medical group serves an area of more than 4.2 million residents
across seven northeast Illinois counties. More than 27,000 team
members and more than 7,100 physician and advance practice provider
partners deliver seamless access to personalized, pioneering,
world-class patient care across more than 300 ambulatory locations
and nine hospitals, including eight Magnet-recognized acute care
hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook
(Glenview), Highland Park, Northwest Community (Arlington Heights),
Skokie and Swedish (Chicago) and Linden Oak Behavioral Health
Hospital (Naperville). For more information, visit
www.endeavorhealth.org.
NOTE: Exact Sciences and Cologuard are trademarks or registered
trademarks of Exact Sciences Corporation. Oncotype is a trademark
of Genomic Health, Inc., a wholly owned subsidiary of Exact
Sciences. All other trademarks and service marks are the property
of their respective owners.
Forward-Looking Statement
This news release contains forward-looking statements concerning
our expectations, anticipations, intentions, beliefs, or strategies
regarding the future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions and events to differ materially from
those anticipated. Therefore, you should not place undue reliance
on forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding the
size and effectiveness of the real-world evidence study discussed
in this news release; the development and commercialization of the
multi-cancer early detection (MCED) test; the performance
characteristics and health care benefits of the MCED test in a
commercial setting; and the timing and anticipated results of FDA
or any other national regulatory authority submission. Risks and
uncertainties that may affect our forward-looking statements are
described in the Risk Factors sections of our most recent Annual
Report on Form 10-K and any subsequent Quarterly Reports on Form
10-Q, and in our other reports filed with the Securities and
Exchange Commission. We undertake no obligation to publicly update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
1 Siegel RL, et al. Cancer statistics, 2024. CA Cancer J Clin.
2024;74:12–49. 2 Gainhullin V., et. al. Abstract #LB100/11, AACR
2024. 3 Siegel, R. L., Giaquintion, A,N.,& Jemal, A (2024).
Cancer statistics, 2024. CA: a cancer journal for clinicians,
74(1), 12–48. https://doi.org/10.3322/caac.21820
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Exact Sciences Media
Contact: Steph Spanos, sspanos@exactsciences.com, 608-556-4380
Investor Contact: Erik Holznecht,
investorrelations@exactsciences.com, 608-800-6605
Baylor Scott & White Media Contact: Julie Smith,
Julie.Smith@BSWHealth.org, 940-765-7560 Endeavor Health Media
Contact: Keith Hartenberger, keith.hartenberger@eehealth.org,
(630) 527-3929
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