Court Dismisses Exact Sciences’ ‘781 Patent Infringement Claim Against Geneoscopy
Geneoscopy Continues Path Toward Commercialization of ColoSense, Bringing New Innovations in Gastrointestinal Health to Patients in Need
ST, LOUIS, MO – MAY 22, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the United States District Court for the District of Delaware dismissed Exact Sciences’ claim of infringement regarding United States Patent No. 11,634,781 (“the ‘781 patent”) this week. The Court’s ruling concluded that the allegations did not support a claim that Geneoscopy has infringed, or currently is infringing, the ‘781 patent.
The Court’s order directed Exact Sciences to file an amended complaint. It also denied certain technical objections Geneoscopy raised related to other claims. At this stage of the litigation, the Court did not address, nor was it asked to determine, whether the ‘781 patent is valid or enforceable.
“At Geneoscopy, our goal is to advance RNA biomarker technology to provide accurate, reliable screening solutions for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “Geneoscopy is pleased with the Court’s recent dismissal ruling, as we seek to ensure that Exact Sciences cannot impede innovation and advancement in the field of cancer detection by claiming exclusive rights to diagnostic methods it did not invent. We are highly confident in the strength of our intellectual property. We will continue our efforts to bring ColoSense to market, offering a new screening option for the millions of Americans in need.”
Recently FDA-approved, ColoSense is indicated as a screening test for adults 45 years of age or older who are at a typical average risk for developing CRC. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch of ColoSense later this year or early in 2025 to ensure physicians and their patients have timely access to reliable CRC screening options for all eligible age groups.
Related Proceeding
Geneoscopy has separately petitioned the United States Patent and Trademark Office (USPTO) to institute an inter partes review challenging the patentability of the ‘781 patent. As Geneoscopy’s petition explains, nothing in that patent is inventive. Fecal tests for detecting blood protein and nucleic acids recited by the claims are standard, routine methods for preparing a fecal sample for the performance of well-established complementary diagnostic assays. Separating a fecal sample so it can be tested for both blood proteins and nucleic acids is reported throughout the prior art. The claimed method of the ’781 patent is obvious, and the claims directed to the method are invalid.
Exact Sciences recently filed a second complaint in the District of Delaware seeking a declaration that Geneoscopy’s test will infringe U.S. Patent No. 11,970,746, a related patent to the ’781 patent. Geneoscopy believes that this new complaint is likewise baseless and will not disrupt Geneoscopy’s commercialization of ColoSense.
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.
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Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
FDA Approves ColoSense™ - Geneoscopy's Noninvasive Multi-target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test
- In average-risk individuals, ColoSense demonstrated 93% sensitivity for detecting colorectal cancer (CRC) and 45% sensitivity for detecting advanced adenomas (AA).
- The CRC-PREVENT study evaluated more than 1,800 average-risk individuals aged 45-49, representing over 20% of participants. Results in this subgroup showed 100% sensitivity in detecting CRC and 44% sensitivity for AA, offering a promising new tool to combat early-age onset CRC.
ST, LOUIS, MO – MAY 6, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.
Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.1,2
“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”
Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.
Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force's guidelines to recommend initiation of CRC screening at age 45.3 Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.4 Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.5,6
“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It's essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said Anjee Davis, president of Fight CRC. “We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”
FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services.
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:
- Ahlquist, D. A., Taylor, W. R., Yab, T. C., Devens, M. E., Mahoney, D. W., Boardman, L. A., Thibodeau, S. N., Zou, H., Michael, D., Berger, B. M., & Lidgard, G. P. (2012). Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research, 72(8_Supplement), 3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572
- Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. (2012) Aberrantly Methylated Gene Marker Levels in Stool: Effects of Demographic, Exposure, Body Mass, and Other Patient Characteristics. J Mol Biomark Diagn 3:133. doi:10.4172/2155-9929.1000133
- Mehta SJ, Morris AM, Kupfer SS. Colorectal Cancer Screening Starting at Age 45 Years—Ensuring Benefits Are Realized by All. JAMA Netw Open. 2021;4(5):e2112593. doi:10.1001/jamanetworkopen.2021.12593
- American Cancer Society https://pressroom.cancer.org/acs-cff-2024
- Hyams, T., Mueller, N., Curbow, B., King-Marshall, E., & Sultan, S. (2022). Screening for colorectal cancer in people ages 45-49: research gaps, challenges and future directions for research and practice. Translational behavioral medicine, 12(2), 198–202. https://doi.org/10.1093/tbm/ibab079
- US Census data, Geneoscopy estimates (includes US markets only)
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Andrea Sampson
Sampson Public Relations Group
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Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
Geneoscopy to Present Research on Inflammatory Bowel Disease at Crohn’s & Colitis Foundation’s IBD Innovate 2024 Conference
Data shows noninvasive stool RNA technology may help providers assess therapeutic response and monitor disease activity for patients with inflammatory bowel disease
ST. LOUIS, MO – April 3, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, will present research at the Crohn’s & Colitis Foundation’s IBD Innovate 2024 Conference in Cambridge, Mass., April 9-10. The data showcases the potential predictive capabilities of Geneoscopy’s noninvasive stool RNA biomarker technology in informing therapeutic response for patients with inflammatory bowel disease (IBD).
"At Geneoscopy, we are dedicated to pushing the boundaries of innovation in gut health diagnostics and therapeutics," said Erica Barnell, Chief Science and Medical Officer at Geneoscopy. "Through rigorous research and development efforts, we have leveraged RNA-based technology to reveal crucial insights into the effectiveness of therapeutic interventions for individuals suffering from IBD. Our participation at IBD Innovate reaffirms our commitment to advancing precision immunology for patients with IBD."
Dr. Barnell will deliver a platform presentation titled “Noninvasive stool RNA test approximates disease activity and predicts therapeutic response in patients with inflammatory bowel disease” on April 9 at 10:30 a.m. The research examined stool-derived eukaryotic RNA (seRNA) to predict therapeutic response and disease activity in Crohn’s Disease (CD) and Ulcerative Colitis (UC). Stool samples were longitudinally collected from subjects with IBD before and after therapy. seRNA signatures were correlated with CD activity index scores and endoscopies. Random forest models accurately classified disease severity, distinguishing active disease from remission with 81% accuracy and mild from moderate disease with 92% accuracy. Longitudinal data showed that seRNA expression correlated with therapeutic target and lymphocyte burden, indicating response.
Approximately 1 in 100 Americans live with IBD, highlighting a critical need for tools to inform therapy selection. Through noninvasive methods, the company’s technology measures RNA expression profiles, which signal mucosal healing in the colon. The resulting information can empower healthcare providers with actionable insights, enabling tailored treatment options that target their specific needs.
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.
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
Don Hardison Appointed Chairman of the Board at Geneoscopy
ST. LOUIS. MO – November 9, 2023 – Geneoscopy, a life sciences company focused on developing diagnostic tests for gastrointestinal health, has appointed Don Hardison to Chairman of its Board of Directors. With a career spanning over 40 years in executive leadership roles in emerging and Fortune 500 diagnostics, biotechnology, and life sciences companies, Hardison brings a wealth of experience and expertise to Geneoscopy as the company moves toward commercialization of its noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test.
"As an accomplished and respected executive in our industry, Don's expertise and insights will be invaluable in helping steer our efforts to bring innovative, noninvasive diagnostics for gastrointestinal health to the providers and individuals who will benefit the most," said Andrew Barnell, Chief Executive Officer and co-founder of Geneoscopy.
Having previously served as a strategic advisor to Geneoscopy before joining the board in February 2023, Hardison is well-acquainted with the company's vision and strategy. In his expanded role as Chairman of the Board, he will provide insight and guidance as Geneoscopy prepares to commercialize its flagship product—ColoSenseTM, a noninvasive, stool-based, at-home screening test designed to detect colorectal cancer and advanced adenomas in average-risk individuals. Geneoscopy submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for this test based on the favorable results from the pivotal CRC-PREVENT trial recently published in JAMA.
"As an advisor and board member, I have been impressed by what Geneoscopy has accomplished, and I'm honored to assume the role of Chairman of the Board at Geneoscopy during this exciting inflection point for the company," said Hardison. "As we move forward, my primary focus will be supporting Geneoscopy’s talented leadership team by helping to guide its commercialization strategies, advance the company's development, and drive its growth in gastrointestinal diagnostics."
Hardison's notable career includes serving as the President and CEO of Biotheranostics until its acquisition by Hologic in February 2021, where he played a significant role in the company's success. Before that, he held the positions of President, CEO, and Director at Good Start Genetics. Hardison's experience extends to his tenure as President and CEO of Exact Sciences from 2000 to 2007, where he was instrumental in taking the company public. He also held multiple senior leadership positions at Labcorp, Quest Diagnostics, and SmithKline Beecham.
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 tests for diagnosis, 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.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which constitute forward-looking statements. These forward-looking statements are based on the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
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