Court Ruling Enables Exact Sciences to Proceed with Lawsuit against Geneoscopy

Company asserts that Geneoscopy will infringe patented technology central to its Cologuard colorectal cancer screening test

MADISON, Wis., May 21, 2024--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that a District Court judge denied in part Geneoscopy’s (defendant) motion to dismiss a patent infringement lawsuit filed by Exact Sciences (plaintiff) in the United States District Court for the District of Delaware. This ruling paves the way for Exact Sciences to seek relief for Geneoscopy’s future infringement and false advertising.

Exact Sciences filed the lawsuit in November 2023 to prevent Geneoscopy from infringing upon Exact Sciences’ intellectual property central to its Cologuard® colorectal cancer screening test and to put an end to Geneoscopy’s false and misleading advertising and promotion about the alleged clinical performance and superiority of ColoSense. Rather than answer for its misconduct, Geneoscopy filed a motion to dismiss the case.

"Exact Sciences applauds the Court’s decision to permit our infringement and false advertising claims to proceed," said Kevin Conroy, chairman and CEO of Exact Sciences. "We will continue to vigorously protect and defend our extensive portfolio of patents from unlawful infringement, and we look forward to proceeding with our case against Geneoscopy."

On May 15, 2024, Exact Sciences filed a second complaint against Geneoscopy to defend its intellectual property against infringement in the United States District Court for the District of Delaware. The case asserts a new patent, the ’746 patent, that was issued to Exact Sciences on April 30, 2024. Like the previously asserted ’781 patent, this patent relates to the novel sample collection technologies that have made Exact Sciences’ flagship Cologuard test so successful. When used according to Geneoscopy’s instructions, its ColoSense test infringes upon these same collection techniques. Exact Sciences expects its new case to proceed on a similar schedule as the existing case, given the overlapping issues.

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. NOTE: Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation.

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. 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.

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Contacts

Investor Contact:
Erik Holznecht
Exact Sciences Corp.
investorrelations@exactsciences.com
608-800-6605

Media Contact:
Morry Smulevitz
Exact Sciences Corp.
msmulevitz@exactsciences.com
608-345-8010