• Company asserts that Geneoscopy infringed patented technology central to its Cologuard colorectal cancer screening test

MADISON, Wis., Nov. 17, 2023 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that it has filed a lawsuit against Geneoscopy, Inc. in the United States District Court for the District of Delaware. The lawsuit seeks damages and a court order to stop Geneoscopy from making, using, selling, or offering for sale Geneoscopy's ColoSense product or otherwise infringing on Exact Sciences' U.S. Patent No. 11,634,781 ("the '781 Patent"). The filed complaint can be accessed on the Exact Sciences' website. 

Exact Sciences utilizes the patented '781 technology in its Cologuard® stool DNA-based colorectal cancer screening test. The patent covers clinically important methods for processing collection of fecal samples at home, in a manner that preserves the integrity of biomarkers contained in the sample to allow for subsequent analysis in a clinical laboratory.

After receiving a cease-and-desist letter from Exact Sciences regarding its patent infringement, Geneoscopy requested a reexamination of the '781 patent by the United States Patent and Trademark Office (USPTO) in May 2023. Upon completion of the reexamination in October 2023, the USPTO rejected Geneoscopy's challenge, confirming the patentability of all claims of the '781 patent for Exact Sciences.

"Exact Sciences pioneered a significant scientific breakthrough that has touched millions of patient lives. We worked tirelessly to develop Cologuard, a first-of-its-kind diagnostic that has been used to screen for colorectal cancer more than 13 million times," said Kevin Conroy, chairman and CEO of Exact Sciences. "As a company deeply rooted in innovation, we understand the vital role of intellectual property, and we will vigorously defend our patents."

Since 2009, Exact Sciences has invested hundreds of millions to study Cologuard and at-home cancer screening technology in 26 clinical trials that included 256,000 participants. The company holds more than 70 U.S. and over 140 internationally issued Cologuard patents, with more than 80 patent applications pending worldwide.

About Cologuard

Results from Exact Sciences' prospective, 90-site, point-in-time, 10,000-patient pivotal trial, DeeP-C, were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2023). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuard.com. Rx only.

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.

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. For example, there can be no assurance as to developments related to the litigation, the outcome of the litigation, or remedies that could be awarded in connection with the litigation; our ability to establish or maintain our intellectual property and other proprietary rights; our business, IP, or legal strategies; or our ability to successfully and profitably market our current products or services or bring new products or services to market. 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 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.

Investor Contact:                                                        
Erik Holznecht
Exact Sciences Corp.
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608-800-6605

Media Contact:
Morry Smulevitz
Exact Sciences Corp.
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608-345-8010