Exact Sciences and West German Study Group Announce New Study to Validate Detection of Minimal Residual Disease in Early-Stage Breast Cancer Patients

ADAPT Triad minimal residual disease analysis study intended to evaluate the association between circulating tumor DNA (ctDNA) positivity and recurrence intervals

MADISON, Wis., Aug. 2, 2022 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, announced today that it has entered a collaboration agreement with the West German Study Group (WSG), an international research institution that focuses on practice-changing clinical studies in breast cancer. Together, Exact Sciences and WSG plan to conduct a prospective, multicenter validation study in hormone receptor (HR)-positive, HER2-negative early breast cancer patients. The study is intended to demonstrate the ability of Exact Sciences' tumor-informed ctDNA liquid biopsy test to detect minimal residual disease (MRD) and to collect important long-term follow-up and outcome data.

The combined analysis, called ADAPT Triad, is expected to include data from approximately 3,000 German patients enrolled in two ongoing WSG ADAPT trials and one WSG registry study. All patients included in the analysis are stratified using the Oncotype DX Breast Recurrence Score® test. The study is part of Exact Sciences' global initiative to generate clinical validation data for its tumor-informed ctDNA MRD liquid biopsy test, currently in development. 

"This ADAPT Triad project with WSG offers a tremendous opportunity to help inform treatment decisions and recurrence monitoring, and ultimately improve future outcomes for breast cancer patients," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "In addition to helping validate our MRD assay, we're also eager to better understand the potential synergies involving the predictive and prognostic information provided by our Oncotype DX Breast Recurrence Score® test. WSG's expertise in breast cancer research makes them ideal collaborators to conduct these important MRD studies in HR positive, HER2-negative early breast cancer."

The ADAPT Triad MRD analysis study in breast cancer builds on Exact Sciences and the National Surgical Adjuvant Breast and Bowel Project's (NSABP) CORRECT-MRD II clinical validation study to detect MRD in colorectal cancer patients. These studies will help create a solid evidence foundation for Exact Sciences' MRD program in two core cancer types where the company has established leadership.

"The WSG's ADAPT study program examines ways to achieve patient-specific decision-making for the treatment of early breast cancer based on biological markers," said Professor Nadia Harbeck, Scientific Director of the WSG and Head of the Breast Centre at LMU Klinikum Munich, Germany. "Partnering with our long-time collaborators at Exact Sciences to evaluate the association of post-initial therapy, pre-recurrence ctDNA with distant recurrence-free interval is a worthy addition to our program and will help change the treatment and monitoring program for solid tumors."

About Minimal Residual Disease
Minimal residual disease (MRD) refers to the presence of tumor-specific DNA in the body after cancer treatment. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the blood by solid tumors as part of the tumor growth cycle. Their presence may indicate that a tumor is likely to return. Solid tumors are typically undetected until they are advanced enough to be picked up by a radiologic image or physician examination. The detection of ctDNA at extremely low levels has the potential to provide crucial insights that may help discover cancer recurrence earlier and inform treatment decisions.

About Exact Sciences' MRD Program
The Exact Sciences' MRD program is powered by our in-house capabilities to advance a tumor-informed or a tumor-naïve solution, with an initial focus on tumor-informed (bespoke) with whole exome or whole genome sequencing. This approach identifies somatic genomic alterations in DNA extracted from the patient's tumor tissue and detects a subset of these mutations in ctDNA present in the patient's blood. The MRD test that Exact Sciences is developing is intended for patients diagnosed with solid tumor malignancies to detect ctDNA before, during, and after cancer treatment. Such information may be used for guidance of adjuvant therapy decisions and/or for monitoring of cancer recurrence, in conjunction with other clinicopathological findings, providing more than 12 million testing opportunities in the United States alone.¹

About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its product pipeline to support patients before and throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

About the West German Study Group and ADAPT
The West German Study Group (WSG) is a collaborative academic research group that focuses on the design, organization, and implementation of clinical studies in the field of breast cancer. Its ADAPT studies aim to develop new therapeutic strategies that significantly improve efficacy and tolerability in comparison with existing standard therapies. Its scientific work focusses on the individualization of breast cancer treatment and the development of de-escalated therapeutic strategies with the aim of finding the best possible treatment for each patient. More than 12,000 patients have already participated in WSG studies.

NOTE: Oncotype, Oncotype DX, and Oncotype DX Breast Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements
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. There can be no assurance as that the WSG ADAPT MRD analysis study will successfully validate Exact Sciences' MRD test or that Exact Sciences will be able to successfully develop or market any MRD or recurrence monitoring tests. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of Exact Sciences' most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in Exact Sciences' other reports filed with the Securities and Exchange Commission. Exact Sciences undertakes 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.

Exact Sciences 
U.S. Media Contact: Steph Spanos, sspanos@exactsciences.com, 608-556-4380
Int'l Media Contact: Federico Maiardi, fmaiardi@exactsciences.com, +41 79-138-1326
Investor Contact: Megan Jones, meganjones@exactsciences.com, 608-535-8815

WSG Media Contact: Michael Städele, Michael.Staedele@wsg-online.com, +49 216156623 10

¹ Source: U.S. Census data, Exact Sciences estimates; includes U.S. markets only

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