Geneoscopy’s Dr. Erica Barnell to Present at Women @ Work Summit and American Gastroenterological Association (AGA) Workshop
Presentations to inspire the next generation of woman scientists and highlight recent advancements in colorectal cancer screening
ST. LOUIS, Mo. – November 7, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that Erica Barnell, MD, PhD, Geneoscopy’s Chief Medical & Science Officer, will present two important topics in November, showcasing her work as a woman leader in the sciences, as well as an update on advancements in colorectal cancer (CRC) screening and early detection.
2nd Annual Women @ Work Summit at Washington University at St. Louis
- Topic: Influencing Across Generations
- Date & Time: Nov. 8, 2024, from 3:13-4:35 p.m. CT
- Location: Emerson Auditorium
- About: The panel discussion, hosted by the McKelvey Women & Engineering Center and the Olin Undergraduate Programs Office, will help prepare students for the workforce and unpack how spheres of influence affect women in a particular way. Dr. Barnell will focus on her experience as a woman leader in the sciences and co-founder of a successful biotech company.
American Gastroenterological Association (AGA) Workshop
- Topic: Optimizing Colorectal Cancer Screening
- Date & Time: 16, 2024, from 9 a.m.-3 p.m. ET
- Location: AGA Headquarters, Bethesda, MD
- About: In this discussion, Barnell joins Dr. David A. Lieberman, Oregon Health and Science University; Dr. Chyke Doubeni, The Ohio State University Wexner Medical Center; and Dr. Dominique E. Howard, Capital Digestive Care, to discuss the current landscape of CRC screening, the state of screening adherence, lessons learned from real-world screening models, and how to develop a clinical pathway for CRC screening.
“These events offer an incredible platform to highlight the impact of leadership as a female physician and scientist, emphasizing the essential role of innovative screening methods in healthcare,” Dr. Barnell said. “At the leadership summit, I look forward to sharing my journey in biotech, where diverse voices and perspectives have been instrumental in building Geneoscopy. At the AGA Workshop, I will have the opportunity to collaborate with esteemed colleagues to explore advancements in colorectal cancer screening, providing a unique opportunity to strengthen clinical pathways that can drive early detection and save lives.”
More than 44 million Americans at average risk for CRC remain unscreened despite screening’s vital role in early detection and prevention. Access to reliable options for screening enhances the ability to detect disease early and provides valuable information to guide personalized treatment options. Geneoscopy’s FDA-approved noninvasive CRC screening test, ColoSense™, is the first to use an RNA-based assay, offering a dynamic view of disease activity.
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 GI disease areas. 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
Geneoscopy Receives New York State Department of Health Permit, Expanding Ability to Provide Laboratory Services Nationwide
ST. LOUIS, Mo. – October 1, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, received its laboratory permit from the New York State Department of Health. Geneoscopy is now able to provide laboratory services in all 50 states and the District of Columbia. The company’s first commercially available laboratory test will be ColoSense™, an FDA-approved, noninvasive multi-target stool RNA (mt-sRNA) screening test for colorectal cancer (CRC) and advanced adenomas..
The New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) regulates and oversees laboratories that accept clinical specimens originating in New York State. The CLEP seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State.
“New York’s CLEP is known to have the most rigorous review process and standards for clinical laboratories, and we believe that this permit reflects the high standard of quality and precision of our laboratory,” said Julie LaRocca, Senior Vice President of Quality Assurance and Regulatory Affairs at Geneoscopy. “Our goal at Geneoscopy is to provide patients with a reliable, accessible, noninvasive option for early detection of CRC. Receiving this permit marks a key milestone in our efforts to offer ColoSense to patients nationwide.”
Colorectal cancer is the second deadliest cancer in the US; however, millions of eligible patients avoid screening due to unpleasant procedures or the perceived low risk of developing CRC. Expanding access to new screening tools will enhance the ability to detect disease early and provide valuable information to guide personalized treatment options. Geneoscopy’s CRC screening test, ColoSense, is the first noninvasive option to use an RNA-based assay, offering a dynamic view of disease activity without dependence on age-related methylation patterns.
Geneoscopy is a Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) accredited laboratory. In total, CLIA oversees approximately 320,000 laboratory entities, and the CAP Laboratory Accreditation Program is considered a benchmark for excellence in clinical laboratory accreditations, ensuring that laboratories adhere to strict guidelines for quality, safety, and accuracy. Additionally, Geneoscopy’s CLIA/CAP laboratory is the only facility approved by the US FDA to process 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. 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.
Geneoscopy’s pivotal CRC-PREVENT trial results 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 GI disease areas. 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
Geneoscopy to Present at Gastroenterology and Cancer Surveillance Conferences, Highlighting Advancements in Colorectal Cancer Screening and Early Detection
ST. LOUIS, Mo. – August 4, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that Erica Barnell, MD, PhD, Geneoscopy’s Chief Medical & Science Officer, will present at two important healthcare conferences, showcasing advancements in colorectal cancer (CRC) screening and early detection.
Cambridge Healthtech Institute’s Early Cancer Surveillance Dx Roundtable Breakout Discussions
- Topic: “Blood-based Colorectal Cancer Screening Tests – Ready for Prime-Time as a First Line Screening Test?”
- Date & Time: Aug. 21, 2024, at 9:30 a.m. EDT
- About: The presentation will shed light on the latest data and perspectives on blood-based CRC screening tests and examine recent clinical trial results. The discussion will review the benefits of blood tests, including higher patient compliance and broader demographic reach, while also addressing the challenges posed by lower sensitivity in detecting stage 1 cancer and pre-cancers compared to standard tests like colonoscopy and at-home, stool-based screening tests.
American College of Gastroenterology Virtual Grand Rounds
- Topic: “What the Practicing GI Clinician Needs to Know About Stool-Based Testing”
- Date & Time: Aug. 22, 2024, at 12:00 p.m. and 8:00 p.m. EDT (a pre-recorded session will also be available on ACG Education Universe on Aug. 30, 2024)
- About: In this discussion, Dr. Barnell and Dr. Thomas F. Imperiale, Indiana University School of Medicine and the Regenstrief Institute, will delve into the significance of stool-based testing, covering its use and implications, and role for practicing gastroenterologists. The session will explore the comparative advantages of stool-based tests over blood tests and colonoscopies, examine how sensitivity and specificity rates affect test selection, and discuss key factors influencing the recommendation of stool-based testing to patients.
“I am honored to participate in these important discussions alongside leading researchers to help advance the field of gastroenterology and early CRC detection,” Dr. Barnell said. “By exploring the latest in stool-based and blood-based testing, we are paving the way for more accurate, accessible, and patient-friendly screening methods. Our goal is to ensure that patients benefit from these innovations, leading to earlier cancer detection, better treatment outcomes, and ultimately, improved survival rates.”
More than 44 million Americans at average risk for CRC remain unscreened despite screening’s vital role in early detection and prevention. Access to reliable options for screening enhances the ability to detect disease early and provides valuable information to guide personalized treatment options. Geneoscopy’s FDA-approved noninvasive CRC screening test, ColoSense™, is the first to use an RNA-based assay, offering a dynamic view of disease activity.
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 GI disease areas. 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
Geneoscopy’s CEO Andrew Barnell to Present at Upcoming Investor Conferences
ST. LOUIS, Mo. – August 8, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that Chief Executive Officer and Co-founder Andrew Barnell, MBA, will attend the following investor conferences:
- Canaccord Genuity 44th Annual Growth Conference in Boston
- Fireside Chat on Tuesday, August 13, at 2:00 p.m. ET
- Morgan Stanley 22nd Annual Global Healthcare Conference in New York City
- Presentation on Thursday, September 5, at 3:20 p.m. ET
- Bank of America Healthcare Trailblazers Private Company Conference in Boston on Thursday, September 26
“It’s an honor to present the promising market opportunity of Geneoscopy’s proprietary RNA-based platform,” said Andrew Barnell, CEO and Co-founder of Geneoscopy. “We are proud of our technology’s ability to provide a reliable, scalable, and cost-effective evaluation of RNA biomarkers from stool samples, delivering the ideal platform for developing diagnostic tests to evaluate and improve gastrointestinal health.”
Geneoscopy recently received FDA approval for ColoSense™, a noninvasive colorectal cancer (CRC) screening test. Despite the critical importance of early detection and prevention, more than 44 million average-risk Americans remain unscreened. ColoSense stands out as the only CRC screening test that utilizes RNA biomarkers, which are not subject to age-related patterns that can lead to variability in test performance across different age groups – a challenge for methylation-based assays.1,2
Additionally, Geneoscopy is expanding the use of its proprietary RNA technology to develop diagnostic tests for treatment selection and therapy monitoring for patients with inflammatory bowel disease (IBD). Collaborating with leading pharmaceutical companies and academic institutions, Geneoscopy is striving to deliver promising tools for healthcare providers to aid in predicting and monitoring therapeutic effectiveness for the approximately 3 million Americans who live with IBD.
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 GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
References:
- 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
- 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
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
Geneoscopy’s Novel Stool-Based RNA Platform Shows High Accuracy in Monitoring Crohn’s Disease
ST. LOUIS, Mo. – August 1, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced the publication of a peer-reviewed study in Gastro Hep Advances, highlighting the effectiveness of Geneoscopy’s noninvasive, stool-based RNA technology platform in managing Crohn’s disease (CD). The data demonstrates the feasibility to leverage stool-based RNA biomarkers to improve disease monitoring within inflammatory bowel disease (IBD).
The study, titled “Noninvasive stool RNA test approximates disease activity in patients with Crohn’s disease,” assessed 102 stool samples from 68 individuals, collected over multiple time points before and after the initiation of advanced therapy. The test demonstrated 83% sensitivity and 80% specificity in distinguishing between active disease and remission. Additionally, a secondary classifier successfully differentiated between mild and moderate disease severity among those with active disease, achieving 89% sensitivity and 95% specificity.
“Patients with Crohn’s disease are plagued by unpredictable periods of remission and relapse, necessitating frequent monitoring to assess disease activity and response to therapy,” said Erica Barnell, Chief Medical & Science Officer at Geneoscopy. “Using RNA biomarkers in stool samples to approximate disease activity in CD offers a noninvasive and patient-friendly approach that mitigates the need for physician appointments and uncomfortable procedures like repeated endoscopies. This study demonstrates that Geneoscopy’s technology has the potential to change how we manage and treat CD, enhancing patient outcomes and quality of life.”
CD affects more than 1 million individuals in the U.S.,1 often leading to serious complications and requiring surgery for up to 80% of patients.2 Maintaining long-term remission is crucial to effectively avoid complications, surgery, malignancy, and other side effects.3-5 Despite advancements in treatment options, accurately evaluating disease severity and predicting therapeutic outcomes remain challenging. Geneoscopy’s platform has the potential to deliver more accurate tracking of disease progression, and provide a cost-effective, convenient way to monitor the disease, reducing healthcare expenses and overall burden.
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 GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
References:
- Lewis JD, Parlet LE, Funk MLJ, et al. Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterol. 2023;165:1197-1205.e2.
- Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterol. 2011;140(6):1785-1794.
- Ashton JJ, Green Z, Kolimarala V, Beattie RM. Inflammatory bowel disease: long-term therapeutic challenges. Expert Rev Gastroenterol Hepatol. 2019;13(11):1049-1063.
- Gupta N, Bostrom AG, Kirschner BS, et al. Incidence of stricturing and penetrating complications of Crohn’s disease diagnosed in pediatric patients. Inflamm Bowel Dis. 2010;16(4):638-644.
- Dubinsky MC, Lin YC, Dutridge D, et al. Serum immune responses predict rapid disease progression among children with Crohn’s disease: immune responses predict disease progression. Am J Gastroenterol. 2006;101(2):360-367.
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
U.S. Patent Trial and Appeal Board Institutes Inter Partes Review Based on Geneoscopy’s Petition Challenging Validity of ‘781 Patent Owned by Exact Sciences
ST. LOUIS, Mo. – July 29, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) to review the patentability of U.S. Patent No. 11,634,781 (“the ‘781 patent”) owned by Exact Sciences.
Upon considering the petition and accompanying evidence, as well as Exact Sciences’ response, the PTAB determined that Geneoscopy established a reasonable likelihood that it would prevail in showing that all 20 challenged claims of the ‘781 patent are unpatentable. The decision can be found on the PTAB website.
“The PTAB’s decision to institute an IPR against the ‘781 patent is a positive step for Geneoscopy,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This ruling highlights our long-held belief that the ‘781 patent claims are invalid and that the patent infringement suit brought by Exact Sciences is meritless. At Geneoscopy, we remain dedicated to expanding choice and access to safe, effective, and convenient screening options, potentially saving countless lives.”
Geneoscopy filed the IPR petition after Exact Sciences brought suit in the U.S. District Court for the District of Delaware alleging infringement of the ‘781 patent. As the petition explained, nothing in the ‘781 patent is inventive. The claimed method of the patent is obvious, and the claims directed to the method are invalid. The PTAB’s decision strengthens Geneoscopy's defenses to the allegations in the patent lawsuit. Geneoscopy has also filed a countersuit against Exact Sciences, alleging breach of contract, misappropriation of trade secrets, unfair competition, and various state and federal law violations.
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.
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
Peer-Reviewed Study Confirms Reliability of ColoSense, Geneoscopy’s Noninvasive Multi-target Stool RNA Colorectal Cancer Screening Test
ST. LOUIS, Mo. – July 10, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced the publication of a study in The Journal of Molecular Diagnostics, highlighting the analytical validation of ColoSense™, a noninvasive, multi-target stool RNA (mt-sRNA) screening test for colorectal cancer (CRC) and advanced adenomas (AAs) in average-risk individuals aged 45 and older.
“ColoSense is the first FDA-approved CRC screening test to leverage stool-based RNA biomarkers, providing a consistent sensitivity profile for all average-risk patients from the youngest to the older population – a challenge for methylation-based assays,” said Dr. Erica Barnell, Chief Science and Medical Officer at Geneoscopy. “These study results position us to continue advancing diagnostic technologies that will help meet the growing demand for reliable and accessible cancer screening solutions for the 44 million Americans at average risk for CRC.”
The study, "Analytical Validation of the Multitarget Stool RNA Test for Colorectal Cancer Screening,” demonstrated ColoSense's high stability, precision, and reproducibility. Researchers evaluated 12 analytical validation studies as part of the pre-market approval application to the FDA to determine analytical sensitivity, linearity, precision, and robustness, among other parameters. Key findings indicated that the test detects low levels of specific RNA markers and maintains accuracy across a wide range of testing conditions. The study's data further validates ColoSense’s assay robustness, which obtained 93% sensitivity for CRC and 45% sensitivity for AAs in average-risk individuals.
CRC is the second most common cause of cancer death in the United States. However, millions of Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. While traditional colonoscopy is the gold standard for detecting CRC and AAs, noninvasive tests like ColoSense offer an essential alternative for patients who are noncompliant with colonoscopy recommendations. The recent lowering of the recommended screening age from 50 to 45 years by the United States Preventive Services Task Force and the American Cancer Society has expanded the need for effective CRC screening methods.
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 GI disease areas. 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
Geneoscopy Files Counterclaims Against Exact Sciences
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
ST, LOUIS, MO – JULY 1, 2024 – 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:
- 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
- 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
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
Geneoscopy Advances Mission to Transform Gastrointestinal Health at Digestive Disease Week 2024
Company highlights capabilities of noninvasive stool-based RNA technology platform for improving patient outcomes in IBD and CRC
ST, LOUIS, MO – MAY 24, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, presented key research findings that showcased the capabilities of its stool-based RNA platform at the Digestive Disease Week (DDW) 2024 meeting. Results showed that Geneoscopy’s novel RNA technology can assess therapeutic response for patients with inflammatory bowel disease (IBD) and transform colorectal cancer (CRC) screening, potentially impacting millions of patients in need. Geneoscopy also participated in three invite-only panel presentations hosted by Colorectal Cancer Alliance, Fight CRC, and Johnson & Johnson.
“Participating and presenting at DDW offered an incredible opportunity to highlight the potential of Geneoscopy’s noninvasive RNA technology in transforming gastrointestinal health,” said Dr. Erica Barnell, Chief Science and Medical Officer at Geneoscopy. “Our company is at the leading edge of a new frontier where healthcare providers are empowered with actionable insights from innovative tests that help prevent, detect, and monitor disease, ultimately improving patient outcomes.”
A poster, titled Stool-derived eukaryotic RNA assay approximates disease activity index and predicts therapeutic response in patients with Crohn’s disease on advanced therapies, found that the RNA signatures showed high accuracy in distinguishing subjects with active disease from those in remission with further subcategorization of active inflammation based on disease severity. This method demonstrated consistent detection of RNA biomarkers in stool samples and effective prediction of therapeutic response across different targeted therapies.
A second poster presentation, titled Development of a second-generation multi-target stool RNA test (ColoSense 2.0) for colorectal cancer screening, demonstrated a preliminary ability to leverage bio-banked stool samples to improve the accuracy of Geneoscopy’s RNA-based ColoSense test, which recently received FDA approval for CRC screening of average-risk individuals over the age of 45. Novel stool-based RNA biomarkers improved sensitivity for detecting CRC and advanced adenomas while maintaining high specificity for no lesions on colonoscopy. Ongoing efforts aim to enhance the ColoSense performance by identifying novel biomarkers to further refine its diagnostic accuracy utilizing next-generation sequencing technology.
“In addition to presenting these impactful study results at the DDW meeting in Washington D.C., our team engaged with advocacy partners, policymakers, professional societies, and legislative bodies to address the pressing issues in gastrointestinal health,” said Matt Sargent, Chief Commercial Officer at Geneoscopy. “As the number of Americans suffering from gastrointestinal diseases increases, it’s crucial that we come together and take the needed steps to educate and offer both physicians and their patients better, more convenient, and personalized treatment options.”
Studies have shown that approximately 30% of IBD patients do not respond to initial treatment, highlighting a critical need for tools to inform therapy selection. Additionally, compliance rates for preventative measures like CRC screening remain low. More than 44 million Americans at average risk for CRC remain unscreened despite screening’s vital role in early detection and prevention. Geneoscopy’s technology provides reliable, scalable, and cost-effective evaluation of RNA biomarkers from stool samples, delivering the ideal platform for developing diagnostic tests for gastrointestinal health.
About DDW
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an annual in-person and online meeting. This year’s meeting was held from May 18-21, 2024 in Washington, D.C. and showcased more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
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 GI disease areas. 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