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.
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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
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
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Andrea Sampson
Sampson Public Relations Group
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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.
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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
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 Expands Leadership Team to Support ColoSense™ Rollout and Advance Precision IBD Solution
ST, LOUIS, MO – MAY 15, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, has appointed Matt Sargent as Chief Commercial Officer and Tyler Aldredge as Vice President of Operations to support commercialization of ColoSense, which recently received FDA approval for colorectal cancer screening (CRC) in average-risk individuals over 45 years of age. Sargent and Aldredge will also help expand the company’s RNA platform to inflammatory bowel disease (IBD) diagnostics, offering providers and patients a promising tool for predicting and monitoring therapeutic effectiveness.
“We are pleased to welcome Matt and Tyler to the Geneoscopy team at such a pivotal time for the company,” said Andrew Barnell, Geneoscopy’s co-founder and Chief Executive Officer. “Matt’s proven experience commercializing oncology diagnostic products and Tyler’s expertise in operational process and management will be critical as we accelerate toward bringing ColoSense to market and hit several key clinical and development milestones with IBD.”
“As I step into this new role, I look forward to collaborating with our talented team and partners to realize the full potential of our innovative RNA technology and bring valuable solutions to patients and providers,” said Sargent. “With our focus on advancing ColoSense and expanding precision diagnostics for IBD, we are poised to make a meaningful impact in improving outcomes for the 60-70 million Americans suffering from GI diseases.”
Sargent brings 20 years of experience leading high-performance commercial teams in the oncology space. Most recently, he served as Chief Business Officer at Harbinger Health, responsible for business development related to the company’s blood-based cancer early detection test. Before Harbinger Health, he was Vice President of Commercial Oncology at Hologic, responsible for sales, commercial strategy, and business development for the CLIA oncology diagnostics service business, following Hologic’s acquisition of Biotheranostics, where he served as Chief Commercial Officer.
Aldredge brings more than 30 years of leadership, operations management, and operational quality experience across a range of multi-site laboratories and facilities, along with extensive proficiency in process development and laboratory set-up, scale-up, and automation. Before joining Geneoscopy, Aldredge served as Vice President of Lab Operations, Facilities, and Real Estate with Bluerock Therapeutics. He is a member of the Society for Laboratory Automation and Screening and serves on the Lab-of-the-Future Committee.
Sargent and members of Geneoscopy’s leadership team will attend Digestive Disease Week 2024 in Washington, D.C., May 18-21 (booth #1407). Additionally, two posters will be presented at the meeting, demonstrating the capabilities of Geneoscopy’s stool-based RNA platform:
- Stool-derived eukaryotic RNA assay approximates disease activity index and predicts therapeutic response in patients with Crohn’s disease on advanced therapies
- Date & Time: May 18, 2024, from 12:30 PM to 1:30 PM
- Development of a second-generation multi-target stool RNA test (ColoSense 2.0) for colorectal cancer screening
- Date & Time: May 19, 2024, from 12:30 PM to 1:30 PM
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 Forms Scientific Advisory Board to Support Advancement of Precision Immunology Diagnostics for Inflammatory Bowel Disease (IBD)
ST. LOUIS, MO – January 17, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the formation of its Scientific Advisory Board (SAB), comprised of leading physicians in inflammatory bowel disease (IBD) who will provide strategic input based on their deep scientific knowledge and clinical expertise. Together, they will guide Geneoscopy through the development of their RNA-based technology to assess stool samples for epithelial and immunological markers that may predict individual response to IBD therapeutics and improve monitoring of disease activity.
“Establishing a Scientific Advisory Board focused on IBD is a significant step forward in our mission to transform GI health,” said Erica Barnell, MD, PhD, Chief Medical and Scientific Officer of Geneoscopy. “It is an honor to have such distinguished advisors to help us identify significant opportunities to advance methods for IBD diagnostics using our innovative RNA technology. Their valuable insights undoubtedly will enhance our endeavors to bring much-needed IBD management tools to patients and clinicians. ”
Matthew A. Ciorba, MD (Chair), Professor of Medicine, Washington University School of Medicine
- Director, Inflammatory Bowel Diseases Center
- Director, IBD Research
Ashwin N. Ananthakrishnan, MD, MPH, Associate Professor of Medicine, Harvard Medical School
- Director of the Crohn's and Colitis Center at Massachusetts General Hospital
Marla C. Dubinsky, MD, Professor of Pediatrics and Medicine (Gastroenterology), Mount Sinai Medical Center
- Chief, Division of Pediatric Gastroenterology at Mount Sinai Kravis Children’s Hospital
- Co-Director, Susan and Leonard Feinstein Clinical IBD Center
Parambir S. Dulai, MD, Associate Professor of Medicine, Director of GI Clinical Trials and Precision Medicine, Feinberg School of Medicine Northwestern University
- Division of Gastroenterology and Hepatology
Laura E. Raffals, MD, MS, Professor of Medicine, Mayo Clinic
- Department of Medicine Associate Chair of Faculty Development
- Vice Chair of the Division of Gastroenterology and Hepatology
“Geneoscopy’s research efforts could not come at a better time. Nearly 1 out of every 100 Americans are diagnosed with IBD, and that number continues to grow. With many IBD therapies now available or in development, there is an important need for novel tools to help guide clinicians in therapy selection and disease monitoring,” noted Board Chair Matthew A. Ciorba, MD. “I am pleased to serve as Chair of this esteemed group of thought leaders as we help Geneoscopy to identify areas of unmet clinical need and assess the feasibility of applying Geneoscopy’s technology towards an IBD diagnostic product.”
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.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its stool-based RNA biomarker platform and its potential application to IBD, 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.
Geneoscopy's Scientific Advisory Board members are compensated consultants. Their individual perspectives and opinions are based on personal experiences.
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Sampson Public Relations Group
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Gilmartin Group
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Geneoscopy Files Inter Partes Review Petition Challenging Exact Sciences’ Patent
Extensive prior art renders Exact Sciences’ patent relating to stool collection and processing invalid
ST. LOUIS, Mo. – (BUSINESS WIRE) – January 12, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that it has petitioned the United States Patent and Trademark Office (USPTO) for inter partes review challenging the patentability of United States Patent No. 11,634,781 (“the ’781 patent”) owned by Exact Sciences. The filed petition can be accessed on Geneoscopy’s website.
Nothing in the ’781 patent’s claims is inventive. The petition explains that the claims of the ’781 patent are directed to the separation of a fecal sample into two portions to permit two standard diagnostic tests – one detecting blood proteins and the other detecting nucleic acids – to be performed on the sample. The fecal tests for detecting blood protein and nucleic acids recited by the claims were known and routine. The method claimed by the ’781 patent amounts to no more than the routine use of standard methods to prepare 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.
“Geneoscopy stands deeply committed to advancing our patented RNA biomarker technology, which helps enable the early detection and prevention of pre-cancerous polyps and colorectal cancer (CRC), with the highest, consistent sensitivity levels for patients of all ages,” said Andrew Barnell, CEO and cofounder of Geneoscopy. “With the goal of expanding cancer screening options and improving outcomes for millions of patients, Geneoscopy seeks to ensure that Exact Sciences does not foreclose innovation and advancement in the field of cancer detection by claiming exclusive rights to diagnostic methods it did not invent. We strongly deny Exact Sciences’ allegations and will vigorously defend our ability to fulfill our mission to empower patients and providers to transform gastrointestinal health.”
Related Litigation
On December 22, 2023, Geneoscopy moved to dismiss the civil action pending in the United States District Court for the District of Delaware entitled Exact Sciences Corp. v. Geneoscopy, Inc., in which Exact Sciences has asserted baseless claims of infringement of the ’781 patent. Geneoscopy’s motion requests the dismissal of the complaint in its entirety.
CRC-PREVENT Study
Results from Geneoscopy’s 8,920 patient CRC-PREVENT clinical study to assess the clinical validity of Geneoscopy’s CRC screening test, ColoSenseTM, were recently published in the Journal of American Medical Association (JAMA). JAMA reported that ColoSense demonstrated the highest level of sensitivity for CRC (94%) and advanced adenomas (AA) (46%) reported by any other commercially available non-invasive screening test. For stage 1 cancers, ColoSense demonstrated 100% sensitivity. Additionally, CRC-PREVENT showed that ColoSense’s RNA-based platform offers consistent sensitivity performance for CRC and AA detection across eligible age groups. In contrast, prospective studies of an existing DNA-methylation-based test have yet to demonstrate its CRC sensitivity and reveal a material decline in its ability to detect AA in average-risk individuals ages 45-49, a group that consists of 19 million Americans.1 Given the rising CRC incidence in younger Americans, upon approval from the FDA, ColoSense will represent a promising new tool to help reduce incidence and mortality from this prevalent, yet preventable type of cancer
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, 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
References:
- 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
Geneoscopy and Adiso Therapeutics Announce Strategic Collaboration to Investigate New Therapeutic Options for Patients with Inflammatory Bowel Disease
Adiso to Utilize Noninvasive RNA Technology Developed by Geneoscopy as a Precision Immunology Measure in ADS051 Phase 2 IBD Trial
ST. LOUIS, Mo., and CONCORD, Mass. – Dec. 5, 2023 – Geneoscopy, Inc., a life sciences company focused on developing noninvasive diagnostic and precision medicine tools for gastrointestinal health, and Adiso Therapeutics, Inc., a clinical-stage biotechnology company advancing novel medicines to treat inflammatory diseases, today announced a strategic collaboration to further treatment options available for patients with inflammatory bowel disease (IBD). The agreement allows Geneoscopy’s patented RNA biomarker technology to be used in conjunction with ADS051, a first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation being developed by Adiso for the treatment of IBD.
“Utilizing our RNA biomarker platform to assess stool samples from IBD patients and categorize response to treatment with ADS051 is an exciting opportunity,” said Andrew Barnell, CEO of Geneoscopy. “Our technology shows significant promise to enhance IBD clinical trials by identifying patients likely to respond to a particular therapeutic and, through noninvasive methods, determining therapeutic effectiveness through the measurement of RNA expression profiles which signal mucosal healing in the colon.”
“The addition of noninvasive stool-based RNA technology from Geneoscopy within our Phase 2 trial of ADS051 is a perfect complement to our neutrophil-targeted, gut-restricted, non-systemic therapy,” said Scott Megaffin, CEO of Adiso. “Employing precision immunology within our trial holds the potential to significantly advance our ability to provide IBD patients with a novel and highly differentiated treatment option that targets their specific needs.”
As part of the Adiso ADS051 Phase 2 trial in patients with ulcerative colitis, Geneoscopy will prospectively assess stool-based transcriptome changes in patients treated with ADS051 to identify immunological markers that may predict individual response. Beyond its utility in identifying likely responders to therapy, preliminary research has also indicated that Geneoscopy’s RNA biomarker technology could provide a noninvasive method of determining clinical remission that is more accurate than traditional diagnostics such as fecal calprotectin. In subsequent clinical trials, Adiso will leverage the Geneoscopy biomarker panel to employ a precision immunology approach that uses stool-derived eukaryotic RNA (seRNA) to assess mucosal healing and predict patient response to therapy.
This collaboration comes at a critical time for the estimated 3 million Americans living with IBD. Despite an increased focus on improving treatment and patient care, effective tools are lacking to inform therapy selection, and significant opportunities exist to advance and refine methods for disease monitoring.
The Adiso ADS051 Phase 2 clinical study will be conducted globally and begin recruiting in 2024.
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.
About Adiso
Adiso is a clinical-stage biopharmaceutical company dedicated to improving the health of patients suffering from debilitating inflammatory diseases. This dedication is epitomized by our lead clinical candidates, which exemplify 'healthruption' (disruption in healthcare and drug development) with novel mechanisms of action and a distinct approach to the treatment of inflammatory diseases. ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation via inhibition of MRP2 and FPR1 for the treatment of ulcerative colitis; and ADS032, a dual NLRP1/NLRP3 inflammasome inhibitor initially being developed for inflammatory diseases of the lung. Adiso has built development programs upon a rich history of institutional and academic collaboration, including, the University of Massachusetts Chan Medical School, the Hudson Institute of Medical Sciences Centre for Innate Immunity and Infectious Diseases in Australia, the University of Edinburgh Centre for Inflammation Research and the University College Cork, Ireland, the APC Microbiome Institute. For more information, please visit www.adisotx.com or our LinkedIn page.
About ADS051
ADS051 is a novel first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation via MRP2 and FPR1 receptor inhibition. ADS051 is a locally acting targeted therapy that addresses the underlying pathophysiology of disease while sparing the peripheral role of neutrophil function. Unlike currently available therapies, ADS051 addresses neutrophil-mediated tissue damage, a hallmark of UC. UC is a form of IBD that causes inflammation and ulcers in the colon. Neutrophils are a type of white blood cell that plays a key role in the body's immune response. In UC, neutrophils are recruited to the colon in large numbers, where they release a variety of inflammatory mediators that cause tissue damage. ADS051 gut restriction, safety and tolerability after oral dosing has been demonstrated in a healthy subject Phase 1a clinical study. In a healthy volunteer Single Ascending Dose study and in a moderate to severe UC patient Phase 1b Multiple Ascending Dose study, oral doses of ADS051 were safe and well-tolerated and largely restricted to the gut with limited systemic exposure while demonstrating encouraging signals of pharmacologic activity and clinical benefit.
Geneoscopy Media and IR Contacts
Geneoscopy Corporate Contact:
Judy Pretto, Director-Communications
Judy.pretto@geneoscopy.com
Media:
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
562-304-0301
Investor Relations
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
Adiso Media and IR Contacts
Argot Partners
Media: Sarah Sutton/Liza Sullivan
IR: Collin Beloin
Adiso@argotpartners.com
212.600.1902
