Decision removes last patent hurdle as Geneoscopy advances ColoSense®, its RNA-based noninvasive colorectal cancer screening test
ST. LOUIS–(BUSINESS WIRE)–Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 10 challenged claims of Exact Sciences’ U.S. Patent No. 11,970,746 (the ’746 patent) unpatentable. This decision follows the PTAB’s July 2025 Final Written Decision invalidating all 20 claims of Exact Sciences’ U.S. Patent No. 11,634,781 (the ‘781 patent). As a result, all patent claims asserted by Exact Sciences against the company in the parties’ ongoing litigation have now been invalidated by the PTAB.
The PTAB’s ruling concluded that all claims of the ’746 patent challenged by the company before the PTAB are unpatentable in view of prior art describing stool sample collection and processing. The PTAB’s decision to invalidate all challenged claims of the ‘746 patent, following its final decision invalidating all claims of the ‘781 patent, further confirms Geneoscopy’s long-held position and clears the path for the continued commercialization of ColoSense.
“The PTAB’s final decisions on these two patents validate what we have believed all along—that the claims in both the ’781 patent and the ‘746 patent being asserted by Exact Sciences against the company should never have been issued,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This outcome underscores that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. These final decisions are also a critical step toward protecting patient choice and advancing high-quality, innovative, noninvasive screening solutions.”
Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit against the company in the U.S. District Court for the District of Delaware. The PTAB’s ruling on the ‘746 patent removes all of Exact Sciences’ patent challenges against ColoSense in that case, as all patent claims asserted against the company in the litigation have now been invalidated by the PTAB.
As part of the litigation, Geneoscopy has filed counterclaims against Exact Sciences alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition (Exact Sciences Corporation v. Geneoscopy, Inc., C.A. No. 23-1319-MN (D. Del.)).
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.
About Geneoscopy, Inc.
Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Contacts
Investor Contact:
Amit Bhalla
Chief Financial Officer
314 887 7777
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