Results from prospective molecular residual
disease (MRD) study show a positive Oncodetect test result is
strongly associated with recurrence in stage III colon cancer
patients
Oncodetect test achieved the primary endpoint
in a second clinical validation study, extending its prognostic
value into stages II and IV colon cancer and rectal cancer
Exact Sciences plans to launch the Oncodetect
test in Q2 2025 with Medicare coverage
Key collaborations support clinical evidence
generation across multiple solid tumor types
Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of
cancer screening and diagnostic tests, shared clinical validation
data for its OncodetectTM MRD test at the 2025 American Society of
Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI.)
Results from Alpha-CORRECT, a study with one of the longest MRD
surveillance monitoring periods to date, showed the Oncodetect test
achieved 78% sensitivity at the post-surgical timepoint and 91%
sensitivity during the surveillance monitoring period, with
specificities of 80% and 94%, respectively1. The complete findings
of the study, which primarily included patients with stage III
colon cancer, will be published in a peer-reviewed scientific
journal on January 25.
“We’re thrilled to bring our MRD solution to the rapidly growing
molecular residual disease market, helping more patients get access
to critical, high-quality testing,” said Brian Baranick, general
manager of Precision Oncology at Exact Sciences. “These data
demonstrate the strong performance of Oncodetect. Building on the
foundation of Oncotype DX® and two decades of trust from physicians
and patients, Exact Sciences is well positioned to lead the way
with its robust commercial and operational infrastructure, to
ensure patients across the U.S. have access to MRD testing.”
In addition to the data shared at ASCO GI, Oncodetect achieved
its primary endpoint in the Beta-CORRECT study. Results confirm a
significant association between MRD positivity and recurrence in
patients with stage III colon cancer. The data extend Oncodetect’s
prognostic value to patients with stage II and IV colon cancer and
rectal cancer. Findings from the independent Beta-CORRECT clinical
validation study, which was a subset analysis from the GALAXY
study, also demonstrated promising performance of Oncodetect as an
MRD test. Results will be presented at an upcoming scientific
conference.
“There is a critical need to better understand and monitor for
residual cancer following surgery,” said Takayuki Yoshino, MD,
deputy director at the National Cancer Center Hospital East in
Japan. “The Oncodetect test represents an exciting development in
the field. I am pleased to partner with Exact Sciences, encouraged
by the emerging data from the Beta-CORRECT study, and look forward
to sharing further insights in the coming months.”
The company plans to provide the Oncodetect test to patients
across the United States through its Precision Oncology platform,
combining 20 years of deep relationships with healthcare
professionals through Oncotype DX, a broad portfolio of oncology
solutions, and the advanced ExactNexusTM technology platform.
Strategic Partnerships Support Multi-Cancer Evidence
Generation
Exact Sciences has partnered with the National Surgical Adjuvant
Breast and Bowel Project (NSABP) and Flatiron Health to generate
additional clinical evidence across multiple solid tumor types.
- Exact Sciences is conducting multiple studies to strengthen
evidence in colorectal cancer. The international-based CORRECT-I
study and the pivotal, US-based CORRECT-II study with the NSABP
will assess the association between ctDNA and recurrence at
specific post-surgical timepoints in patients with stage II and III
colorectal cancer. These studies will further validate ctDNA’s role
in colorectal cancer recurrence monitoring.
- An additional study with the NSABP, EXActDNA-003, is one of the
largest prospective MRD studies across all subtypes of early-stage
breast cancer. Additional research in breast cancer was previously
announced with the West German Study Group.
- The company has also partnered with Flatiron Health on a
multi-year, prospective real-world study that will be integrated
into routine clinical care, with the goal of accelerated enrollment
across a broad range of solid tumors.
“The NSABP is committed to advancing colorectal and breast
cancer care through innovative clinical studies that redefine
diagnostics and treatments,” said Dr. Norman Wolmark, MD, chairman
of the NSABP Foundation and contact principal investigator and
co-chair at NRG Oncology. “Both the CORRECT-II and EXActDNA-003
studies are designed to utilize ctDNA in addressing critical gaps
left by previous MRD trials. Through our collaboration with Exact
Sciences, we aim to integrate ctDNA analysis to deliver a more
precise and comprehensive approach to recurrence detection.”
About the Oncodetect test
Molecular residual disease (MRD) refers to the presence of
tumor-specific DNA in the body. These fragments of genetic
information, known as circulating tumor DNA (ctDNA), are shed into
the bloodstream by tumors, and their presence may indicate that
cancer is present. Exact Sciences’ MRD offering leverages our
in-house capabilities in whole exome sequencing to offer a
tumor-informed MRD test for a personalized approach to detecting
and monitoring residual cancer in patients with solid tumors. By
identifying somatic genomic alterations in tumor DNA and detecting
a subset in ctDNA from blood, the Oncodetect test may enable the
detection of ctDNA before, during, and after treatment. This
critical information can guide therapy decisions and monitor for
cancer recurrence.
About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable
genomic insights to inform prognosis and cancer treatment after a
diagnosis. In breast cancer, the Oncotype DX Breast Recurrence
Score® test is the only test shown to predict the likelihood of
chemotherapy benefit as well as recurrence in invasive breast
cancer. The Oncotype DX test is recognized as the standard of care
and is included in all major breast cancer treatment guidelines.
The OncoExTra® test applies comprehensive tumor profiling,
utilizing whole exome and whole transcriptome sequencing, to aid in
therapy selection for patients with advanced, metastatic,
refractory, relapsed, or recurrent cancer. With an extensive panel
of approximately 20,000 genes and 169 introns, the OncoExTra test
is one of the most comprehensive genomic (DNA) and transcriptomic
(RNA) panels available today. Exact Sciences enables patients to
take a more active role in their cancer care and makes it easy for
providers to order tests, interpret results, and personalize
medicine by applying real-world evidence and guideline
recommendations. To learn more, visit
precisiononcology.exactsciences.com.
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 regarding our expectations for
the commercialization of the Oncodetect test and the performance of
the Oncodetect test in a commercial setting. 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:
- Schoen RE, Diergaarde B, Young G, et al. Circulating tumor DNA
as a marker of recurrence risk in stage III colorectal cancer: The
α-CORRECT study. Presented at ASCO GI on January 21, 2025.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250121399220/en/
Media (US) Lisa Warshaw lwarshaw@exactsciences.com
Investors Erik Holznecht +1 608-800-6605
investors@exactsciences.com
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