Legal Win for Geneoscopy as Exact Sciences Withdraws Preliminary Injunction Against ColoSense®

ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that Exact Sciences has withdrawn its motion for a preliminary injunction regarding U.S. Patent No. 11,634,781 ("the '781 patent") and U.S. Patent No. 11,970,746 (“the ‘746 patent”).

Exact Sciences’ preliminary injunction motion, filed in July 2024, sought to prevent Geneoscopy’s commercialization of its stool-based colorectal cancer screening test, ColoSense. The withdrawal is consistent with Geneoscopy’s firmly held view that the preliminary injunction motion was baseless. This development allows Geneoscopy to continue expanding access to ColoSense for eligible patients and providers without restriction.

“By taking this step, Exact Sciences confirms what we have said all along—ColoSense is grounded in innovation, not infringement,” said Andrew Barnell, co-founder and CEO of Geneoscopy. “Competition fosters scientific progress and improves patient care. We are excited to continue moving ColoSense forward, bringing a new and patient-friendly cancer screening option to market that enhances early detection and saves lives.”

Withdrawal of the preliminary injunction motion follows other recent favorable developments for Geneoscopy. In July, the U.S. Patent Trial and Appeal Board (PTAB) found all 20 challenged claims of the ’781 patent unpatentable. This was preceded by PTAB’s decision to institute review of a second patent asserted by Exact Sciences (the ‘746 patent) on substantially the same grounds cited by the PTAB in invalidating the ‘781 patent.

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.