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
EAC is the most common form of esophageal cancer in the
“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
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
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
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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
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.
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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. Accessed26 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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