Exact Sciences Advances Development of Non-Endoscopic Oncoguard® Esophagus Test to Screen for Esophageal Cancer and Pre-Cancer

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 Hepatologyjournal.

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:

1. 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.
2. 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.
3. 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/
4. 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/
5. 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
6. 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.
7. National Cancer Institute. Cancer Stat Facts: Esophageal Cancer. Accessed 26 March 2024.
   https://seer.cancer.gov/statfacts/html/esoph.html
8. 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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