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

Rhea-AI Summary

Exact Sciences Corp. collaborates with Mayo Clinic to develop a non-endoscopic screening tool for esophageal adenocarcinoma and its precursors, showing high sensitivity and specificity in detecting early stages of the cancer. The test aims to address the critical need for screening in high-risk populations, with potential to revolutionize esophageal cancer detection.

Positive

• The collaboration between Exact Sciences Corp. and Mayo Clinic aims to develop a non-endoscopic screening tool for esophageal adenocarcinoma and its precursors.
• The Oncoguard Esophagus test demonstrates high sensitivity and specificity in detecting early stages of esophageal cancer.
• Esophageal adenocarcinoma (EAC) is rapidly becoming one of the deadliest cancers, with over 80% of patients dying within five years of diagnosis.
• The test uses an encapsulated sponge collection device to collect esophageal specimens and assay for methylated DNA markers (MDMs).
• The study showed an overall sensitivity of 82% for Barrett's esophagus detection at 90% specificity in the training set and 88% sensitivity at 84% specificity in the test set.
• The test aims to provide a minimally invasive, accurate, and cost-effective solution for earlier detection of EAC and its precursors.
• The Oncoguard Esophagus test is currently under development and has not been cleared or approved by the FDA.
• Mayo Clinic and Dr. Iyer have a financial interest in the technology referenced in the press release.

Negative

• None.

Insights

Oncology Doctor

The emergence of a non-endoscopic screening tool like Oncoguard Esophagus test represents a significant step forward in the early detection of esophageal adenocarcinoma (EAC). The high sensitivity and specificity rates reported in the study, particularly the 100% sensitivity for detecting EAC and Barrett's esophagus (BE) with high grade dysplasia, suggest that this tool could effectively identify individuals at an earlier stage when the disease is more treatable. As an oncologist, the potential to shift the diagnosis of EAC from late to early stages could dramatically improve patient outcomes, given that the 5-year survival rate plummets when diagnosed at an advanced stage.

From a clinical perspective, the reported tolerability and office-based implementation of the collection method indicate that this could lead to increased screening rates among high-risk populations. This is important because current screening rates are low due to the invasiveness and cost of traditional methods. By providing a less invasive option, we may see an increase in patient compliance with screening recommendations, which in turn could lead to a reduction in mortality rates associated with EAC.

Medical Research Analyst

As a medical research analyst, the data from Exact Sciences and Mayo Clinic Comprehensive Cancer Center is compelling, particularly the use of methylated DNA markers (MDMs) for the detection of BE/EAC. The use of a three-MDM panel for cross-validation in the study is a noteworthy approach, as MDMs have been increasingly recognized for their role in the early detection of various cancers. The reported specificity and sensitivity rates in both training and test sets are impressive and align with the need for accurate diagnostic tools in oncology.

However, it's important to note that the Oncoguard Esophagus test is still under development and has not received FDA approval. The regulatory path and commercialization strategy will be critical factors in determining the test's impact on the market. Furthermore, the financial interest of Mayo Clinic and Dr. Iyer in the technology could raise questions about potential conflicts of interest, although it's common for academic institutions to have financial stakes in innovations stemming from their research.

Healthcare Market Analyst

From a market perspective, the development of the Oncoguard Esophagus test by Exact Sciences could address a significant unmet need in the market for non-invasive cancer screening tools. The potential market size, considering there are approximately 30 million high-risk individuals in the U.S. alone, indicates a substantial opportunity for Exact Sciences if the test is commercialized. Moreover, the shift towards less invasive screening options aligns with broader healthcare trends aiming to reduce patient burden and healthcare costs.

Investors should monitor the progress of the test's development and look for signals of FDA approval, which would be a major catalyst for Exact Sciences' stock. Additionally, the collaboration with Mayo Clinic not only lends credibility but could also streamline the clinical development process. Ultimately, the adoption rate of the Oncoguard Esophagus test upon approval will depend on factors such as insurance coverage, cost-effectiveness compared to current screening methods and integration into clinical guidelines.

Results indicate potential of a minimally invasive screening tool to detect most common form of Esophageal Cancer, a highly treatable cancer if caught early

MADISON, Wis.--(BUSINESS WIRE)-- 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 Hepatology journal.

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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Investor Contact:

Nathan Harrill

Exact Sciences Corp.

investorrelations@exactsciences.com

608-535-8659

For Immediate Release

Media Contact:

Morry Smulevitz

Exact Sciences Corp.

msmulevitz@exactsciences.com

608-345-8010

Source: Exact Sciences Corp.

FAQ

What is the purpose of the collaboration between Exact Sciences Corp. and Mayo Clinic?

The collaboration aims to develop a non-endoscopic screening tool for esophageal adenocarcinoma and its precursors.

What are the key findings of the study regarding the Oncoguard Esophagus test?

The study showed high sensitivity and specificity for the test in detecting early stages of esophageal cancer.

What is the significance of detecting esophageal adenocarcinoma (EAC) early?

Detecting EAC early is crucial as over 80% of patients with EAC die within five years of diagnosis.

How does the test collect esophageal specimens for analysis?

The test uses an encapsulated sponge collection device to collect esophageal specimens and assay for methylated DNA markers (MDMs).

What sensitivity and specificity levels were observed in the training and test sets for Barrett's esophagus detection?

The study showed an overall sensitivity of 82% for BE detection at 90% specificity in the training set and 88% sensitivity at 84% specificity in the test set.

Is the Oncoguard Esophagus test currently approved by the FDA?

No, the test is currently under development and has not been cleared or approved by the FDA.