New evidence shows multi-biomarker class
approach improved cancer detection, including in earlier stages
when treatment may be more effective
Modeling data estimate adding MCED testing to
standard-of-care screening could reduce cancer mortality by 17%
New analysis from DETECT-A study supports MCED
testing as a complement to current guideline-recommended
screening
Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of
cancer screening and diagnostic tests, will present three abstracts
highlighting significant advancements in the development of a
multi-cancer early detection (MCED) test. The results of a study
evaluating a new multi-biomarker class approach showed improved
sensitivity for early-stage and overall cancer detection. In
addition, new modeling data estimate that adding MCED testing to
recommended screening may reduce the incidence of stage IV cancer
and, subsequently, cancer mortality over 10 years. Another new
analysis from the DETECT-A study suggests that adding MCED testing
complements guideline-recommended lung cancer screening without
affecting adherence to current standard of care. These findings
will be presented at the American Association for Cancer Research
(AACR) Special Conference in Cancer Research: Liquid Biopsy from
November 13-16, 2024, in San Diego, Calif.
“Cancer is on pace to be the leading cause of death in the U.S.
by 20301. Currently, only an estimated 14% of all cancers in the
U.S. are diagnosed through screening,2 revealing a glaring gap in
patient care,” said Tom Beer, M.D., chief medical officer and vice
president, multi-cancer early detection, Exact Sciences. “We
believe MCED testing is our single biggest opportunity to combat
these stark statistics, and the Exact Sciences team is committed to
taking a rigorous, comprehensive approach to multi-cancer
screening. The new data answer key questions about the impact we
can anticipate with MCED testing if integrated into clinical
practice.”
A new study demonstrates the ability of a multi-biomarker class
MCED test to improve early-stage sensitivity by incorporating a DNA
mutation reflex approach to methylation and protein (MP) test
results. When excluding breast and prostate cancer and at a 98.5%
specificity, sensitivity increased by 28% for stage I cancers and
12.5% for early-stage cancers (stages I and II) in a case-control
study, underscoring the potential of a three-biomarker class (DNA
methylation, protein, DNA mutation reflex, or MP-r) test to improve
the detection of cancer in earlier stages.
Cancer stage
MP-r sensitivity
MP sensitivity
% improvement
Stage I
22.1%
17.2%
28.0%
Stage II
54.7%
51.9%
5.5%
Stage I/II
35.9%
31.9%
12.5%
Overall
62.3%
59.3%
5.0%
This new research will help inform the final design of Exact
Sciences’ Cancerguard™ test, which is currently in development and
intends to harness the additive sensitivity of multiple biomarker
classes to detect more cancers in earlier stages.
The abstracts featured at the AACR Special Conference: Liquid
Biopsy 2024 are as follows:
Title: Performance of multi-biomarker class reflex
testing in a prospectively-collected cohort Poster session:
Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A) Poster
number: A056 Key findings: A new analysis from a
case-control study demonstrated the ability of a three-biomarker
class (DNA methylation, protein, DNA mutation reflex, or MP-r) MCED
test approach to increase sensitivity for early-stage detection.
When excluding breast and prostate cancer, stage I sensitivity
increased by 28%, and stage I/II increased by 12.5%.
Title: The potential of multi-cancer early detection
screening for reducing cancer mortality Oral presentation:
Friday, November 15, 9:35 a.m. PT (Plenary Session 4: Early
Detection of Primary Cancer and Relapse) Presenter: Tyson, C
Poster number: PR006, A073 Key findings: New modeling
points to the potential to reduce the burden of cancer by
demonstrating an estimated 42% reduction in stage IV cancer
incidence and a 17% estimated 10-year reduction in cancer mortality
with the addition of MCED testing to usual care.
Title: Lung cancer screening adherence among participants
in DETECT-A, the first prospective interventional trial of a
multi-cancer early detection (MCED) blood test Poster
session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A064 Key findings: Analysis from the
prospective, interventional DETECT-A study showed lung cancer
screening adherence was not reduced in participants who received an
MCED test compared to controls.
About the DETECT-A study
The DETECT-A (Detecting cancers Early Through Elective
mutation-based blood Collection and Testing) study was the
first-ever large, prospective, interventional study to use a blood
test to detect multiple types of cancer in a real-world setting.
The DETECT-A study enrolled more than 10,000 women with no history
of cancer to determine if a blood test in combination with
standard-of-care screenings could detect cancers before signs and
symptoms appeared. The CancerSEEK test, the MCED test studied in
DETECT-A, was the forerunner to the Cancerguard test, the MCED test
currently in development at Exact Sciences.
About the Cancerguard™ test
The Cancerguard test, currently in development, is designed to
detect multiple cancers in their earliest stages from a single
blood draw. Building upon decades of research, Exact Sciences
intends to harness the additive sensitivity of multiple biomarker
classes to detect more cancers in earlier stages. The Cancerguard
test will utilize a streamlined and standardized imaging-based
diagnostic pathway, which may result in fewer follow-up procedures.
The test is being developed to provide high specificity to help
minimize false positives while detecting multiple cancers,
including those with the biggest toll on human health. These
features describe current development goals. The Cancerguard test
has not been cleared or approved by the U.S. Food and Drug
Administration or any other national regulatory authority. To learn
more, visit http://www.exactsciences.com/cancerguard.
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.
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
development and commercialization of the Cancerguard test, and the
performance characteristics and healthcare benefits of the
Cancerguard test. 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.
References:
- CDC Archive. Future Health of our Nation Infographic. Accessed
July 12, 2024.
- NORC at the University of Chicago. New Research Highlights Just
One In Seven Diagnosed Cancers Found By A Recommended Screening
Test. Accessed October 31, 2024. Limitations: Based on modeling
data derived from numerous sources including self-reported surveys.
Includes assumptions on detectability of certain cancer types. Does
not include all cancer types or screening methods.
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version on businesswire.com: https://www.businesswire.com/news/home/20241113756824/en/
Exact Sciences Media
Contact: Allison Barry, abarry@exactsciences.com, 980.297.1957
Investor Contact: Erik Holznecht,
investorrelations@exactsciences.com, 608.800.6605
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