Decision removes key patent hurdle as Geneoscopy advances ColoSense®, its RNA-based noninvasive colorectal cancer screening test

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 20 challenged claims of U.S. Patent No. 11,634,781 (the ’781 patent) unpatentable.

The PTAB’s ruling concluded that all claims of the ’781 patent are obvious considering prior art related to stool sample collection and processing. The decision to invalidate the ‘781 patent confirms Geneoscopy’s long-held position and clears the path for the continued commercialization of ColoSense.

“The PTAB’s final decision validates what we have believed all along—that the claims in the ’781 patent should never have been issued,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This outcome not only reinforces the strength of our position but helps ensure that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. It’s a critical step toward protecting patient choice and advancing high-quality, noninvasive screening solutions.”

Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit in the U.S. District Court for the District of Delaware. The PTAB’s ruling bolsters the company’s defenses in that case and follows the Board’s earlier decision in February to institute review of a second patent asserted by Exact Sciences (U.S. Patent No. 11,970,746) on largely the same grounds on which the ‘781 patent was just invalidated. In parallel to the pending litigation, Geneoscopy has filed a countersuit alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250710114351/en/