Exact Sciences and National Surgical Adjuvant Breast and Bowel Project Announce Clinical Validation Study to Detect Minimal Residual Disease in Colorectal Cancer Patients

MADISON, Wis., Sept. 14, 2021 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, announced today that it has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences' ctDNA test to detect MRD. The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences' global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test. 

"Our longstanding relationship with the NSABP, through our work to develop and validate the Oncotype DX Breast Recurrence Score^® and Colon Recurrence Score^® tests, represents a remarkable collaboration between academic and industry partners. This relationship has fueled major advancements in understanding the role of molecular profiling in breast and colon cancer," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "NSABP's expertise in colon research makes them ideal collaborators to conduct this important MRD study in colorectal cancer. We look forward to working together on this tremendous opportunity to help shape the future of precision medicine."

Exact Sciences is well-positioned to bring a highly sensitive MRD solution to patients in need. Its recent exclusive license of the Targeted Digital Sequencing (TARDIS) blood biopsy technology and acquisition of Ashion Analytics help prepare Exact Sciences to develop a differentiated patient-specific solution in MRD testing. With proven evidence-generation abilities and deep commercial relationships, Exact Sciences has the capability to bring its solution to patients and providers in the U.S. quickly and efficiently. In addition, the patient specific MRD test may have the potential to be synergistic with the predictive and prognostic insights provided by the Exact Sciences' Oncotype^® portfolio to further inform treatment decisions to help improve patient outcomes. The company aims to explore the full potential of its MRD technology across all solid tumor types.

"The NSABP is committed to designing and conducting clinical trials that improve the treatment of colorectal cancer by evaluating promising new diagnostics and treatments," said Norman

Wolmark, MD, chairman of the NSABP Foundation and of the NCTN group NRG Oncology. "Highly sensitive MRD tests have the potential to fundamentally change the solid tumor treatment and monitoring paradigm. Exact Sciences' unique approach to MRD and its commitment to improving patient outcomes make them ideal collaborators for advancing this promising new technology."

Exact Sciences and the NSABP are also working with patient advocacy organization Fight Colorectal Cancer (Fight CRC) to help inform MRD study designs and identify potential barriers to study participation, particularly in underserved populations. This joint effort will help ensure patient recruitment and patient-facing study materials are clear and sensitive to diverse cultures and socioeconomic backgrounds.

"Participating in a clinical study or trial is a personal journey and decision that includes many different factors and considerations for each patient," said Anjee Davis, president of Fight CRC. "Collaboration between patients, patient advocates, and clinical study professionals is vital. We're proud to work with Exact Sciences and the NSABP on this important research, ensuring colorectal cancer patients from all backgrounds are represented and their voices are kept at the forefront."

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 medical 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 solution is being designed to utilize a tumor-informed (bespoke) approach with whole genome sequencing. This approach identifies somatic genetic 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 or neoadjuvant therapy decisions and/or for monitoring of recurrence after completion of adjuvant or neoadjuvant therapy, in conjunction with other clinicopathological findings. The company estimates that more than 1.5 million patients¹ in the United States alone could benefit from this type of MRD testing.

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 take on some of the deadliest cancers and improve patient care. 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 National Surgical Adjuvant Breast and Bowel Project (NSABP)
The NSABP is a not-for-profit, clinical trials cooperative group, which includes a network of well over a thousand clinicians located in over 700 institutions throughout the U.S., Canada, Europe and Asia. Research conducted by the NSABP is supported by funding from the NCI and industry sponsors. For more than 60 years, the NSABP has successfully conducted large-scale, randomized clinical trials in colorectal and breast cancer that have altered and improved the standard of care for men and women with these diseases. To learn more about the NSABP, please visit www.nsabp.org. 

About Fight Colorectal Cancer
Fight Colorectal Cancer (Fight CRC) is a leading patient-empowerment and advocacy organization in the United States, providing balanced and objective information on colon and rectal cancer research, treatment, and policy. We are relentless champions of hope, focused on funding promising, high-impact research endeavors while equipping advocates to influence legislation and policy for the collective good. Learn more at FightCRC.org.

NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, and Oncotype DX Colon 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 CORRECT MRD-II 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, [email protected], 608-556-4380
Int'l Media Contact: Federico Maiardi, [email protected], +41 79-138-1326
Investor Contact: Megan Jones, [email protected], 608-535-8815

NSABP Media Contact:  Michelle Shepard, [email protected], 412-339-5347
Fight CRC Media Contact: Nancy Levesque, 703-548-1225, [email protected]

¹ Exact Sciences estimates

SOURCE EXACT SCIENCES CORP

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