Exact Sciences Advances Development of Non-Endoscopic Oncoguard® Esophagus Test to Screen for Esophageal Cancer and Pre-Cancer
March 28 2024 - 6:00AM
Business Wire
Results indicate potential of a minimally
invasive screening tool to detect most common form of Esophageal
Cancer, a highly treatable cancer if caught early
Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of
cancer screening and diagnostic tests, in collaboration with Mayo
Clinic Comprehensive Cancer Center, reported on data showing high
sensitivity and specificity for the non-endoscopic Oncoguard®
Esophagus test that is currently in development for the detection
of esophageal adenocarcinoma (EAC) and its precursors, including
Barrett’s esophagus (BE).1,2 Findings from the test’s algorithm
training and testing were recently published in the Clinical
Gastroenterology and Hepatology journal.
EAC is the most common form of esophageal cancer in the U.S.
with incidence having increased significantly over the past few
decades compared to other, more common types of cancer where rates
have either declined or remained flat due to advanced technologies
in screening.3,4 The majority of EAC cases are diagnosed in
advanced stages, with early EAC typically having no signs or
symptoms, making screening in high-risk populations a critical
need.5 There are approximately 30 million people in the U.S. who
are at high-risk for EAC and should be screened.6
“Esophageal adenocarcinoma (EAC) is quickly becoming one of the
deadliest cancers, with over 80% of patients dying within five
years of diagnosis.7 Barrett’s esophagus (BE) is the only known
precursor to EAC and patients with BE have an increased risk of
progressing to EAC if not caught early. Standard methods of
screening can be invasive and costly for patients, which is why
there has been a recent push to change the screening guidelines to
include non-endoscopic tests,” said Prasad G. Iyer, MD, Professor
of Medicine, Division of Gastroenterology and Hepatology, Mayo
Clinic Comprehensive Cancer Center. “In collaborating with Exact
Sciences, we are able to study the potential of a minimally
invasive, non-endoscopic screening tool currently in development in
patients at higher risk for EAC. Our algorithm training and testing
study accomplishes the next critical step for the accurate,
non-endoscopic detection of BE/EAC.”
The study used an encapsulated sponge collection device to
collect esophageal specimens from 352 participants in the training
set and 125 participants in the test set. These were then blindly
assayed for methylated DNA markers (MDMs). Cross-validation of the
three-MDM panel demonstrated an overall sensitivity of 82% (CI, 68%
to 94%) for BE detection at 90% specificity (CI, 79% to 98%) in the
training set and 88% sensitivity (CI, 78% to 94%) at 84%
specificity (CI, 70% to 93%) in the test set. In both training and
test sets, sensitivity was 100% for EAC and BE with high grade
dysplasia (HGD) – both treatment-eligible subsets. The collection
method was generally well tolerated by study participants and was
conducive to office-based implementation.
“In esophageal cancer, earlier screening and detection will
provide an important advance, as we have seen in other cancers.
While many experts recommend that people with chronic reflux
disease and at least one other risk factor be screened for
Barrett’s esophagus, only a small number of eligible patients
undergo screening currently,”8 said Paul Limburg, Chief Medical
Officer of Screening, Exact Sciences. “At Exact Sciences, our work
has always focused on the latest innovations in screening and
testing to help patients and clinicians have accurate, less
invasive, and cost-effective options. We are collaborating with
Mayo Clinic to continue the development of the Oncoguard Esophagus
test as a minimally invasive solution for earlier detection of EAC
and its precursors.”
The Oncoguard Esophagus test is currently under development and
features of the test described above are outlining current
development goals. This test has not been cleared or approved by
the U.S. Food and Drug Administration (FDA) or any other national
regulatory authority.
Mayo Clinic and Dr. Iyer have a financial interest in the
technology referenced in this press release. Mayo Clinic will use
any revenue it receives to support its not-for-profit mission in
patient care, education and research.
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.
NOTE: Exact Sciences, Cologuard and Oncoguard are trademarks or
registered trademarks of Exact Sciences Corporation. Oncotype is a
registered trademark of Genomic Health, Inc., a wholly-owned
subsidiary of Exact Sciences Corporation. 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
development and commercialization of the Oncoguard Esophagus test;
the performance characteristics and healthcare benefits of the
Oncoguard Esophagus 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. 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
Oncoguard Esophagus test; the performance characteristics and
healthcare benefits of the Oncoguard Esophagus 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.
References:
- Iyer, P. G., Taylor, W. R., et al. Highly Discriminant
Methylated DNA Markers for the Non-endoscopic Detection of
Barrett's Esophagus. Am J Gastroenterol 2018, 113 (8),
1156-1166.
- Iyer, P. G.,Taylor, W. R., et al. Accurate Nonendoscopic
Detection of Barrett’s Esophagus by Methylated DNA Markers: A
Multisite Case Control Study. Am J Gastroenterol 2020, 115 (8),
1201-1209.
- Cook D, et al. Gastrointest Endosc Clin N Am. 2021 Jan; 31(1):
1–26. Accessed 26 March 2024.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887893/
- He H, et al. Thorac Cancer. 2020 May; 11(5): 1121–1128.
Accessed 26 March 2024.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7180574/
- Then T E, et al. World J Oncol. 2020 Apr; 11(2): 55–64.
Accessed 26 March 2024.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141161/#:~:text=Background,rate%20of%20less%20than%2025%25
- Chandar, A.K., Low, E.E., et al. Estimated Burden of Screening
for Barrett’s Esophagus in the United States. Gastroenterology.
Volume 165, Issue 1, p283-285.E2, July 2023.
- National Cancer Institute. Cancer Stat Facts: Esophageal
Cancer. Accessed 26 March 2024.
https://seer.cancer.gov/statfacts/html/esoph.html
- Eluri S, et al Am J Gastroenterol. 2022 Nov 1; 117(11):
1764–1771.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9633338/
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version on businesswire.com: https://www.businesswire.com/news/home/20240328804544/en/
Investor Contact: Nathan Harrill Exact Sciences Corp.
investorrelations@exactsciences.com 608-535-8659 For Immediate
Release
Media Contact: Morry Smulevitz Exact Sciences Corp.
msmulevitz@exactsciences.com 608-345-8010
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