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Geneoscopy Files Counterclaims Against Exact Sciences

By: via Business Wire

The Company is confident that litigation will not delay the commercial launch of ColoSense™, its FDA-approved RNA biomarker screening test for colorectal cancer and advanced adenomas

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, filed a lawsuit asserting multiple claims for damages against Exact Sciences on June 28, 2024, in federal court in the District of Delaware.

The claims include breach of contract, misappropriation of trade secrets, unfair competition, and other violations of state and federal law that Exact Sciences has committed against Geneoscopy. The Company is seeking remedies including, but not limited to, compensatory and punitive damages, payment of Geneoscopy’s attorneys’ fees, and other legal and equitable remedies.

“We are taking action due to Exact Sciences’ continued wrongful and malicious conduct, including the misappropriation of our proprietary information and trade secrets,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “Attempting to block new products from the market limits screening options for the 44 million Americans at average risk for CRC. We believe our countersuit is an important next step to ensure fair competition and prevent Exact Sciences from impeding innovation and advancement in the field of cancer detection.”

Also on June 28, Exact Sciences filed a motion for a preliminary injunction against Geneoscopy. The motion, filed seven months after the initial suit, is based on two related patent infringement claims, which are limited to specific methods of collecting and processing stool samples. Geneoscopy believes that Exact Sciences’ patent suit and the belated preliminary injunction motion are baseless, and it will vigorously defend its position in court.

“This filing in no way affects our confidence in the strength of our intellectual property,” Barnell said. “We are on track with the commercial launch timeline for ColoSense and remain dedicated to expanding choice and access to safe, effective, and convenient screening options for everyone, potentially saving countless lives.”

Colorectal cancer is the second deadliest cancer in the U.S., with incidence rates rising among younger populations under 50. In response to this growing concern, the U.S. Preventive Services Task Force updated its guidelines to recommend CRC screening starts at age 45. Despite this, millions of eligible Americans avoid screening due to limited access or the invasive nature of options like colonoscopies. This issue is compounded by the fact that only 1 out of 5 people in the 45-49 age group receive screening. ColoSense is the first noninvasive colorectal cancer screening test to use RNA biomarkers to provide a dynamic view of disease activity, which are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.1,2

Related Proceeding

Geneoscopy has separately petitioned the U.S. Patent and Trademark Office (USPTO) to institute an inter partes review challenging the patentability of the U.S. Patent No. 11,634,781. As Geneoscopy’s petition explains, nothing in that patent (which Exact purchased from a third party) is inventive. Separating a fecal sample so it can be tested for both blood proteins and nucleic acids is reported throughout the prior art. Moreover, fecal tests for detecting blood protein and nucleic acids, as recited by the claims, are standard, and the patent purports to claim only routine methods for preparing a fecal sample for the performance of well-established complementary diagnostic assays. The claimed method of the ’781 patent is obvious, and the claims directed to the method are invalid.

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, 45 years of age or older, who are at 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. Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

References:

  1. Ahlquist DA, Taylor WR, Yab TC, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572-3572. https://doi.org/10.1158/1538-7445.am2012-3572
  2. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133

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