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.
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 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
Geneoscopy Signs Multi-Year Agreement with Labcorp to Distribute Noninvasive Multi-Target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test
Collaboration expected to increase provider and patient access to potentially life-saving colorectal cancer screening that enables earlier disease detection
ST LOUIS, MO – November 14, 2023 – Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced a strategic collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services. This multi-year agreement will increase access to Geneoscopy’s next-generation colorectal cancer screening test, which offers at-home collection and high sensitivity for early cancer detection. Geneoscopy’s test is under FDA review. Once approved by the FDA, Labcorp will offer the test, which will be performed by Geneoscopy, enabling health care customers to conveniently order it through Labcorp as part of their comprehensive screening programs.
“Colorectal cancer is one of the most preventable cancers, yet millions of eligible Americans do not get screened as directed by guidelines,” said Vince Wong, Chief Commercial Officer at Geneoscopy. “Working with Labcorp, an organization trusted daily by thousands of clinicians and millions of patients, is an incredible opportunity to expand patient and clinician access to our noninvasive screening test. Given Labcorp’s extensive access to communities across the country, we believe this collaboration will help reduce the barriers to screening and address health inequities.”
Although colorectal cancer ranks second in U.S. cancer-related deaths overall and is the leading cause of cancer death in men younger than 50, research indicates a large proportion of colorectal cancer incidence and mortality is preventable through regular screening, surveillance and high-quality treatment. Adding to this challenge, colorectal cancer incidence trends are rapidly shifting the patient population to younger individuals; 20% (1 in 5) of colorectal cancers in 2019 were in people 54 years or younger, up from 11% (1 in 10) in 1995, and over the past decade, incidence has increased for advanced disease, especially in people younger than 65 years of age. Geneoscopy’s technology offers this age group convenient at-home test collection with the highest sensitivity currently available for non-invasive CRC screening.
“This agreement builds on Labcorp’s commitment to bring the latest advancements in cancer screening and diagnostic testing to healthcare providers and patients,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “Geneoscopy’s highly sensitive colorectal cancer screening test, once approved, will be another innovative, accessible and reliable option available to providers and patients nationwide for the detection of colorectal cancer.”
Geneoscopy’s multi-target stool RNA (mt-sRNA) biomarker panel is designed to detect precancerous lesions and colorectal cancer. The company has submitted a Premarket Approval Application (PMA) to the FDA based on the favorable results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated high sensitivity for CRC and advanced adenomas. Notably, for younger participants (ages 45 to 49), sensitivity for CRC was 100%. These results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date.
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.
Geneoscopy Contact
Judy Pretto, Director-Communications
judy.pretto@geneoscopy.com
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
GI Oncology Today: Multitarget Stool RNA Test Proves Sensitive for Colorectal Cancer, Advanced Adenomas
Erica Barnell, MD, PhD, of Washington University School of Medicine, and founder of Geneoscopy Inc, describes the multitarget stool RNA “ColoSense” test and the CRC-PREVENT study that demonstrated its superior sensitivity and specificity in comparison to traditional colonoscopy.
Originally published in GI Oncology Now | November 7, 2023
Why did you found Geneoscopy and develop the multitarget stool RNA “ColoSense” test?
Dr. Barnell: In 2014, when I entered the MD-PhD program, I was deeply involved in developing technology in the microbiome labs at Wash University. During my clinical rotations, I had a pivotal encounter with an individual who was diagnosed with stage 4 colorectal cancer. This encounter made me realize that in a time when we can sequence the human genome in just 24 hours, we should be able to offer alternative solutions for individuals who either cannot undergo a colonoscopy or for whom it does not align with their lifestyle. This realization inspired me to establish Geneoscopy with the goal of leveraging the microbiome research I had been involved in to improve healthcare solutions for individuals, providing them with options that align with their lifestyles and preferences.
Please detail the CRC-PREVENT study. What kind of patients did you enroll, from where were they sampled, and what were ColoSense test samples compared against?
Dr. Barnell: The ColoSense pivotal study, known as CRC-PREVENT, was a cross-sectional prospective pivotal trial designed to support a pre-market approval application to the FDA. This study was unique in how we recruited patients. We utilized social media advertising to reach patients where they are. Once a patient expressed interest and enrolled in the clinical trial, we would send them a stool sample collection kit, which they would use to provide a stool sample. They would then send the sample back to our laboratory. Afterward, we would facilitate their access to a follow-up colonoscopy. We compared the results of the ColoSense test, whether it was positive or negative, with the results of the colonoscopy to assess the test’s sensitivity for colorectal cancer, sensitivity for advanced adenomas, and specificity for detecting no findings on a colonoscopy.
How did you go about identifying your target participants for the ColoSense test on social media?
Dr. Barnell: Our approach to identifying target participants for the ColoSense test on social media was to target a representative cohort of the approximately 150 million average-risk Americans recommended for colorectal cancer screening. We aimed to include typical individuals over the age of 45 in our study. By employing a decentralized recruitment model, we aimed to obtain a more accurate representation of the population in need of colorectal cancer screening. Instead of relying on site-based recruitment, we were able to reach individuals who had no colonoscopy scheduled at the time of enrollment and who had never previously undergone a colonoscopy or noninvasive screening. Our study targeted individuals who may not have been aware of colorectal cancer screening options or who could not undergo invasive procedures like colonoscopies. These are the individuals for whom ColoSense testing is designed, those who may not be familiar with or cannot tolerate traditional screening methods.
What was the success rate among patients enrolled for undergoing the ColoSense test and getting the colonoscopy?
Dr. Barnell: Through our online enrollment process, we engaged with over 275,000 individuals. Out of that large pool, we identified approximately 14,000 individuals who met our criteria as average-risk, asymptomatic individuals over the age of 45. Among these, around 85% successfully provided a viable ColoSense test to our laboratory. Afterward, about 85% of these patients were successfully guided to undergo a colonoscopy.
What did you find in terms of the sensitivity and specificity of ColoSense testing versus colonoscopy?
Dr. Barnell: In terms of sensitivity and specificity, the ColoSense test showed impressive results when compared to colonoscopy. We achieved the highest sensitivity for colorectal cancer at 94.4%, which is a remarkable outcome. Our test also demonstrated the highest reported sensitivity for advanced adenomas, standing at 46%. Furthermore, the specificity of the ColoSense test for identifying no findings during a colonoscopy was 88%. These results indicate that ColoSense is a highly effective noninvasive screening option for colorectal cancer.
How scalable is the ColoSense test to be commonly used as a noninvasive colorectal cancer screening option?
Dr. Barnell: The ColoSense test has been developed with scalability in mind. We have submitted the data from the pivotal study to the FDA as part of a pre-market approval application. Currently, the FDA is reviewing the data, and we anticipate receiving their decision within the next 3 months. Once we receive FDA approval, we plan to launch the ColoSense test commercially, making it available to healthcare providers and patients. We have established a partnership with a large decentralized laboratory, which will allow us to successfully commercialize this test and reach the 150 million Americans who require colorectal cancer screening. The scalability of the ColoSense test makes it feasible to become a widely used noninvasive colorectal cancer screening option.
Do you believe other “decentralized recruitment efforts” based on regulatory guidance should be used for future trials involving population health screening?
Dr. Barnell: I believe that our decentralized recruitment model has the potential to be a game-changer for future population health screening trials. Our approach offers significant advantages in terms of reaching a diverse and representative cohort, addressing disparities, and ensuring that individuals who traditionally have been underrepresented in clinical trials have the opportunity to participate. The success of our model has even prompted the FDA to produce guidance on the use of decentralized recruitment for clinical trials, which highlights its significance. I hope that our experience will serve as an example for other companies and clinical trials to conduct studies with inclusivity and diversity in mind.
Are there any other takeaways from the ColoSense test or CRC-PREVENT that you would like to add?
Dr. Barnell: Another noteworthy takeaway from the ColoSense test and the CRC-PREVENT study is the high sensitivity and specificity observed in the younger age population (ages 45 to 50). This is particularly significant because colorectal cancer screening recommendations now include individuals aged 45 and above. In our study, approximately 22% of the cohort fell within this age group. We observed 100% sensitivity for colorectal cancer and 45% sensitivity for advanced adenomas in this age bracket. This provides robust evidence that ColoSense testing can effectively screen patients in the 45 to 50 age range noninvasively, offering a valuable option for early detection in this population.
JAMA Publishes Geneoscopy’s Pivotal CRC-PREVENT Trial Results, Reporting Highest Sensitivity for Detecting Colorectal Cancer and Advanced Adenomas Among Available Noninvasive Screening Tests
- Geneoscopy’s noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test showed extraordinary sensitivity for detecting early-stage (Stage 1) colorectal cancer at 100% and advanced adenomas at 46%
- Sensitivity for CRC was 100% among individuals ages 45 to 49, an age group now recommended for screening given the rapid rise of early onset CRC
- Study will be presented at the American College of Gastroenterology 2023 Annual Meeting
ST LOUIS, MO. – Oct. 23, 2023 – Geneoscopy Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, announced a publication in The Journal of the American Medical Association (JAMA), highlighting the company’s pivotal CRC-PREVENT trial results. The novel study will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, Canada, October 20-25, showcasing its highly sensitive screening test for colorectal cancer (CRC) and advanced adenomas (AA). The company will also present findings from its inflammatory bowel disease research at the meeting.
“Although colorectal cancer is the second deadliest cancer in the U.S., millions of eligible Americans do not get screened due to a lack of access or avoidance of invasive options like colonoscopies,” said Erica Barnell, MD, PhD, Chief Science and Medical Officer at Geneoscopy. “Geneoscopy is dedicated to addressing this challenge and improving access to a reliable, noninvasive CRC screening test, especially as incidence is rising among younger populations. Providing reliable tools for early detection allows providers to intervene and start treatment earlier, potentially saving patients’ lives.”
The CRC-PREVENT trial evaluated 8,920 participants (ages 45 and older) using Geneoscopy’s novel mt-sRNA test. CRC was detected with 94% sensitivity, including 100% sensitivity for early-stage (Stage I) CRC. The test also detected AAs with a 46% sensitivity, rising to 50% for AAs over two centimeters in size. Notably, for younger participants (ages 45 to 49), CRC sensitivity was 100% and AA sensitivity was 45%. The study published in JAMA, “CRC-PREVENT: Multi-target Stool RNA Test for Colorectal Cancer Screening,” will be presented at ACG by study co-author David Lieberman, MD, Oregon Health & Science University.
“CRC rates are climbing among younger populations less than 50 years old, prompting a recent shift in screening guidelines from the USPSTF to initiate screening at age 45 years. There is a notable gap in data regarding the efficacy of noninvasive screening tests for this age group, including the sensitivity for colorectal cancer (CRC) and advanced adenomas,” said Dr. Lieberman. “This prospective pivotal study of a new stool-derived RNA test demonstrates excellent sensitivity for CRC and advanced adenomas across the entire age spectrum of adults eligible for CRC screening, including ages 45 to 49. Geneoscopy’s technology can potentially provide millions of people with a convenient and reliable option for detecting and preventing CRC.”
Geneoscopy will also present results at ACG from a recent study predicting therapeutic response and monitoring for mucosal healing for patients with Inflammatory Bowel Disease (IBD) using the company’s RNA technology.
“Geneoscopy’s research and development efforts come at a critical time when 60-70 million Americans suffer from GI diseases, including CRC and IBD,” said Vince Wong, JD, MBA, Chief Commercial Officer at Geneoscopy. “These studies are an example of our commitment to drive research and product development leveraging our proprietary RNA technology to help prevent, detect, monitor, and improve treatment for gastrointestinal diseases.”
Geneoscopy has submitted a Premarket Approval Application (PMA) to the FDA for its noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test.
Geneoscopy’s Presentations at ACG 2023
Oral Presentation: CRC-PREVENT: Multi-target Stool RNA Test for Colorectal Cancer Screening
Session: Plenary Session 3B – General Endoscopy / Practice Management / Colorectal Cancer Prevention
Date & Time: Tuesday, October 24, 2023, from 2:25–2:35 p.m. PT (UTC -7)
Location: Ballroom B
Scientific Poster Presentation: Stool-derived Eukaryotic RNA Biomarkers for Predicting Therapeutic Response and Monitoring Mucosal Healing for Patients with Inflammatory Bowel Disease
Session: Scientific Poster Session – Open & Authors Present
Date & Time: Sunday, October 22, 2023, from 3:30–7 p.m. PT (UTC -7)
Location: Exhibit Hall
About CRC-PREVENT Trial
CRC-PREVENT was a pivotal prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.
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.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com
Geneoscopy to Present and Exhibit at American College of Gastroenterology 2023 Annual Meeting
Company to Showcase Its Noninvasive RNA-based Technology Platform Designed to Improve Diagnostic Tools for Gastrointestinal Health
ST LOUIS, MO – Oct. 5, 2023 – Geneoscopy Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, will present at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, Canada, Oct. 20-25, highlighting how its novel platform technology is being used to develop noninvasive diagnostic and precision medicine tools for gastrointestinal (GI) diseases, such as colorectal cancer (CRC) and inflammatory bowel disease (IBD). The company will also feature its technology at booth #908.
Oral Presentation | Session Details
Session: Plenary Session 3B – General Endoscopy / Practice Management / Colorectal Cancer Prevention
Date & Time: Tuesday, October 24, 2023 from 2:25–2:35 p.m. PT (UTC -7)
Location: Ballroom B
Click here for full details
Scientific Poster Presentation | Session Details
Session: Scientific Poster Session – Open & Authors Present
Date & Time: Sunday, October 22, 2023 from 3:30–6:30 p.m. PT (UTC -7)
Location: Exhibit Hall
Click here for full details
“We are excited about this year’s ACG Scientific Meeting and look forward to sharing the results of our studies with the gastrointestinal (GI) community,” said Erica Barnell, Geneoscopy’s Chief Science and Medical Officer. “We firmly believe that our technology addresses the pressing need for expanded access to more convenient and accurate screening options for CRC and will enable a precision medicine approach to GI disease management and treatment.”
Geneoscopy’s research and development efforts come at a critical time when 60-70 million Americans suffer from GI diseases, including CRC and IBD. Despite declining incidence in the overall population, CRC is increasing amongst individuals under 55 and shifting to a more advanced disease. This trend should motivate everyone 45 and older to get screened. Additionally, despite a significant focus on improving care for the estimated 2.9M people diagnosed with IBD, clinicians and patients lack effective noninvasive tools for therapy selection and disease monitoring.
Geneoscopy is leveraging its novel RNA-based technology platform to address these challenges to develop noninvasive diagnostic and precision medicine tools for GI diseases. The company’s at-home colorectal cancer screening test is designed to detect high-risk precancerous lesions (advanced adenomas) and CRC in average-risk individuals. It received the U.S. Food and Drug Administration’s Breakthrough Device designation in 2020 and has been submitted to the FDA for Premarket Approval.
“Geneoscopy is focused on providing innovative screening and diagnostic tests to help empower patients and providers to transform gastrointestinal health,” said Andrew Barnell, CEO of Geneoscopy. “Given the promise of our technology, we are confident that our pipeline of tests can address gaps in care for patients who critically need noninvasive diagnostics solutions. We want to meet patients where they are with accessible, convenient, and highly accurate tools that fit into their busy lives.”
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.
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.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com
Geneoscopy CEO Andrew Barnell to Present at the Morgan Stanley 21st Annual Global Healthcare Conference
“…We believe that our pipeline of tests will enable a precision medicine approach to GI disease management and treatment, bringing value to healthcare stakeholders, most importantly, patients.”
Andrew Barnell, Geneoscopy CEO and co-founder
ST LOUIS – Sept. 6, 2023 – Geneoscopy Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, today announced that Chief Executive Officer and Co-founder Andrew Barnell, MBA, will be presenting at the Morgan Stanley Global Healthcare Conference in New York, NY, on Monday, Sept. 11, at 2:15 p.m. Eastern Time.
Geneoscopy’s research and development efforts come at a critical time when 60-70 million Americans suffer from gastrointestinal (GI) diseases, including colorectal cancer (CRC) and inflammatory bowel disease (IBD). Many Americans do not get screened for CRC—often due to a lack of access or avoidance of invasive options like colonoscopies, resulting in increased incidence and mortality rates.
In addition, a recent study found that nearly 1 in 100 Americans suffer from IBD, with an estimated 2.39 million diagnosed. Although many IBD therapies are available and in development, clinicians and patients lack effective tools for therapy selection and monitoring to help ensure patients benefit from prescribed therapies.
To address these challenges, Geneoscopy is leveraging its novel platform technology to develop noninvasive diagnostic and precision medicine tools for GI diseases.
“We are pleased to be presenting at Morgan Stanley’s Annual Global Healthcare Conference to share the promising market opportunities for our proprietary RNA biomarker platform and high-value diagnostic tests,” said Andrew Barnell, CEO and Co-founder of Geneoscopy. “Our mission to transform gastrointestinal health begins by addressing the pressing need to expand access to more convenient and accurate screening options for CRC. And we believe that our pipeline of tests will enable a precision medicine approach to GI disease management and treatment, bringing value to healthcare stakeholders, most importantly, patients.”
Geneoscopy’s noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test received U.S. Food and Drug Administration’s (FDA) Breakthrough Device designation in 2020 and has been submitted to the FDA for Premarket Approval (PMA). This at-home screening test is designed to detect high-risk precancerous lesions (advanced adenomas) and CRC in average-risk individuals. In its pivotal CRC-PREVENT clinical trial, the test demonstrated 94% sensitivity for CRC and 46% sensitivity for advanced adenomas. These results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date.
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.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com