Colonic Polyps

Results of a Taiwan-based study are expected to be validated in a new collaboration with a major Japanese medical institution, assessing the higher sensitivity of 3D pathology over conventional sampling techniques across populations and medical systems. HSINCHU, March 27, 2025 /PRNewswire/ -- JelloX Biotech Inc., a Taiwan-based startup at the forefront of anatomic pathology, today announced the results of a recent clinical trial conducted in collaboration with Taipei Medical University Hospital (TMUH). Focusing on the diagnosis and treatment of colorectal cancer, the study applied JelloX's 3D pathology methods to colonoscopy specimens evaluated by conventional 2D methods and identified a significant difference in pathological diagnosis, mostly from reclassifying cases into higher risk categories. Continue Reading Traditional histopathology is limited to two-dimensional observations. Through 3D fluorescent pathology imaging, three-dimensional tubular structures can be clearly visualized, aiding in disease staging and diagnosis. According to the US National Cancer Institute, colorectal cancer is one of the most common types of cancers. However, diagnosis by biopsy, though widely regarded as the most accurate method over non-invasive techniques, continues to pose precision challenges, such as the potential for improper sampling and examination. Dr. Yen-Yin Lin, CEO of JelloX, remarked: "Backed by growing empirical data, the case ca for implementing 3D pathology in oncology is building. The 3D technology's greater sensitivity enables a higher level of precision that can help match the right patients to the right drugs at the right time—ultimately improving treatment and quality of life." New findings in collaboration with TMUH The clinical trial evaluated approximately 160 cases, comparing diagnoses made by traditional 2D pathology with those made using JelloX's 3D pathology on the same colon polyps samples. The findings demonstrated a high inconsistency rate between the two methods. Notably, many of these discrepancies involved cases initially classified as lower-risk by conventional methods but subsequently reclassified to higher-risk categories with 3D analysis. The results suggest that conventional methods may underestimate the malignancy transformation potential of colon polyps due to the limited information derived from the 2D images of a tissue sample. The precision of JelloX's 3D pathology technology shows promise for bringing patients improved treatment and better quality of care. This is particularly important for colorectal cancer, since its asymptomatic nature in the early stages often results in late-stage disease, and early detection greatly improves cure rate. JelloX, TMUH, and Taipei Li-jen Pathology Clinic are partnering to make this innovative technology available in major health check-up centers across Taiwan. Fostering international partnerships in Japan and the US In Japan, JelloX's 3D pathology technology is driving advancements in drug discovery, biomarker research, and precision medicine. The company is collaborating with the National Cancer Center Japan [Exploratory Oncology Research and Clinical Trial Center (EPOC) / National Cancer Center Hospital East] to conduct a study on Japanese colorectal and esophageal cancer patients. Once completed, this study may also show greater sensitivity of the 3D pathology method in a different population and medical system. This collaboration will focus on 3D analysis of the tumor microenvironment in esophageal cancer patients undergoing neoadjuvant chemotherapy (NAC), promising insights into drug development and predictive modeling of chemotherapy efficacy. As it ramps up plans to apply for regulatory approval in Japan, JelloX also plans to establish a central laboratory in Tokyo as a regional service hub for sample processing and diagnostics. In the US, JelloX launched a partnership in 2024 with a major research institution and is making arrangements to establish a central laboratory in Arizona, laying the groundwork for future commercial deployment. For more information or to explore partnerships, please contact JelloX at [email protected]. About JelloX Biotech Inc. Based in Hsinchu, Taiwan, JelloX Biotech Inc. is a startup that focuses on advancing cancer pathology through 3D digital imaging and AI technology. For more information, please visit: SOURCE JelloX Biotech Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CENTER VALLEY, Pa., May 16, 2024 /PRNewswire/ -- Olympus, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today that it will highlight its EVIS X1™ endoscopy system and colorectal cancer screening solutions during the Digestive Disease Week annual meeting May 19-21 in Washington, D.C. Continue Reading Olympus Corporation announced that it will highlight its EVIS X1™ endoscopy system and colorectal cancer screening solutions during the Digestive Disease Week annual meeting in Washington, D.C. The American Cancer Society reports that colorectal cancer deaths have been dropping in older adults for decades likely, in part, due to screenings such as colonoscopy that find polyps before they can develop into cancer or finding cancer earlier when it's more treatable.1 The EVIS X1 endoscopy system features imaging technologies designed to help physicians diagnose, treat and observe diseases and disorders of the upper and lower GI tract, including colorectal cancer. More than 20 years ago, colorectal cancer (CRC) was known to be the fourth-leading cause of cancer death in men and women under the age of 50, according to the American Cancer Society. Now, CRC is the leading cause of cancer death for men under the age of 50 and the second leading cause for women under 50. Since 2015, incidence rates of CRC in adults younger than 55 have increased by 1% to 2% annually.2 The EVIS X1 endoscopy system imaging technologies include Texture and Color Enhancement Imaging (TXI™) technology, which can improve the visibility of potential lesions and may help physicians reduce miss rates for early mucosal changes that can lead to cancer.3 A study evaluating the use of TXI technology on polyp detection during screening colonoscopies found that TXI technology significantly increased physicians' adenoma detection rate (ADR) and increased the number of adenomas measuring 5mm or larger detected, as compared to those found during a procedure using high-definition white-light endoscopy. ADR was also higher with TXI technology (as compared to white light) in patients who were being screened as a result of a positive non-invasive test or due to a history of polyps or bowel cancer.4 TXI technology is not intended to replace histopathological sampling as a means of diagnosis. Other assistive technologies that may increase ADR and help advance colorectal cancer detection include mechanical devices such as the Olympus® Endocuff Vision™ device, which help increase ADR during a colonoscopy by manipulating colonic folds and maximizing the viewable mucosa.5 A rare but potential complication when using Endocuff Vision™ device is the detachment of the device during the procedure. The physician should be prepared to retrieve the device if this were to occur. The physician should ensure Endocuff Vision™ device is used only with compatible colonoscopes, that the colonoscope distal tip is in good condition, and that the device is fully seated on the distal tip prior to the application of lubricant to minimize the chance of detachment. Standard risks of colonoscopy including injury, bleeding and perforation still apply when using the Endocuff Vision™ device. During DDW, Olympus will demonstrate the capabilities of the EVIS X1 system and Endocuff Vision device, as well as offer hands-on demonstrations of ERCP and ESD procedures, live demonstrations of EUS-guided liver biopsy and presentations about the EndoClot® Polysaccharide Hemostatic System (PHS) and Submucosal Injection Solution (SIS) and automation in endoscope reprocessing. For more information, visit the Olympus booth, #3329, during DDW or visit the EVIS X1 endoscopy system product page or the gastroenterology page for the entire Olympus® GI portfolio. About Olympus At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services that will help them with early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 4,500 employees throughout locations in North and South America. For more information, visit olympusamerica.com. 1 American Cancer Society, "Key Statistics for Colorectal Cancer." Rev. Jan. 17, 2024 2 "Cancer statistics, 2024," CA: A Cancer Journal for Clinicians." Pub. Jan. 17, 2024 3 Data on file with Olympus (DC00489968) 4 Young, E; et al, "Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial." Gastroenterology AGA Journal, pub. October 2023 5 Data on file with Olympus as of 12/2016 SOURCE Olympus Corporation of the Americas

Capital Digestive Care will help enable widespread patient access to this groundbreaking predictive tool to help identify lower GI disorders earlier and improve outcomes Available through the Roche navify® Algorithm Suite, LGI-Flag uses demographic information and historical CBC test results to flag individuals at risk for lower GI disorders that warrant further investigation U.S. launch timed to Colorectal Cancer Awareness Month, underscoring significant need to increase screening rates for this deadly disease SILVER SPRING, Md., March 12, 2024 /PRNewswire/ -- Capital Digestive Care, the largest private gastroenterology (GI) practice in the Mid-Atlantic region, today announced that it is launching LGI-Flag in the United States. Available through the Roche navify Algorithm Suite, LGI-Flag is a groundbreaking AI-driven algorithm used to flag individuals at risk for lower GI disorders that warrant further evaluation. With this launch, the Capital Digestive Care Laboratory – the first GI specialty practice recognized as a Roche Diagnostics Center of Excellence – will now use LGI-Flag to screen eligible patients using electronic health record (EHR) and clinical data repositories, contact those identified as being at risk for colorectal cancer and/or other lower GI disorders, and schedule appropriate follow up (e.g., a colonoscopy). "Capital Digestive Care is committed to enabling the digital transformation of healthcare, in order to provide a more personalized, convenient and predictive continuum-of-care for patients," said Michael Weinstein, M.D., CEO of Capital Digestive Care. "Our innovative laboratory, along with our end-to-end continuum-of-care model, makes us an ideal organization to bring this highly sensitive and well-validated tool to provide more precise and predictive care to patients. Now, we have a means to more precisely identify those at high risk of lower GI disorders, including colorectal cancer so they may avoid the devastating effects of the disease through increased screening and earlier detection and treatment." LGI-Flag uses demographic information and historical CBC (complete blood count) test results to flag individuals with CBC patterns that may be associated with an increased risk for lower GI disorders, including but not limited to irritable bowel syndrome (IBS), inflammatory bowel diseases (IBD), and colorectal cancer – the third leading cause of cancer-related deaths in both men and women in the United States.1 Increasing colorectal cancer screening rates has been a priority in the United States for some time, as outcomes improve significantly when asymptomatic polyps and other early-stage cancers are detected and treated early. The U.S. Preventive Services Task Force (USPSTF) colorectal screening guidelines recommend a colonoscopy every 10 years for adults between the ages of 45 and 75 who are considered to be at low to average risk. In addition, the guidelines recommend a non-invasive stool-based screening test, such as the guaiac-based fecal occult blood test (HSgFOBT) or fecal immunochemical test (FIT) (which are recommended annually) and Stool DNA-FIT (which is recommended every 1-3 years).2 However, approximately 32% of age-eligible U.S. adults do not follow the current colorectal cancer screening guidelines3 and only approximately 37% of cases are diagnosed at an early stage.4 LGI-Flag can be used on its own to identify patients at increased risk, or with a non-invasive stool-based screening test to provide additional information about an individual's risk and whether they require further evaluation versus a stool-based screening test alone. "We're excited that through Capital Digestive Care, LGI-Flag will now be offered to a large number of patients in the U.S. to help improve care for people with wide-ranging lower GI disorders and support the critical mission to increase colorectal cancer screening rates," said Moritz Hartmann, Global Head of Roche Information Solutions. "This helps advance that mission by offering a highly effective and clinically validated machine-learning-based algorithm to identify those at increased risk of a wide array of lower GI disorders, including colorectal cancer." About LGI-Flag LGI-Flag, developed by Medial EarlySign and available via the navify Algorithm Suite from Roche, is an evidence-based way to identify patients who are at risk for colorectal cancer and other lower GI disorders. The tool requires only a patient's existing CBC results, along with the individual's birth year and gender, to calculate a risk score and flag those in need of follow-up screening. A prospective real-world study published in the New England Journal of Medicine in 2022 identified patients overdue for colorectal cancer screening and used LGI-Flag to flag those at highest risk for abnormal results.5 Patients were then informed of their risk and offered to schedule a colonoscopy to complete their screening. Of those flagged patients, approximately 70% had a significant finding. Overall, colorectal cancer was found in 8% of flagged patients who underwent a colonoscopy and had their results documented, 22% were found to have advanced adenomas (a classification of colon polyps that have a higher likelihood of developing into malignant polyps), and 29% were found to have adenomas/polyps. "We're proud to now offer LGI-Flag to our large and diverse body of patients to help improve health outcomes without increasing patient burden," said Laura Vivian, Executive Director of Capital Digestive Care Laboratory. "This launch builds upon our existing relationship with Roche Diagnostics and will further advance our ability to seamlessly deliver more personalized and actionable insights to revolutionize care for the patients we serve." About Capital Digestive Care Founded in 2009, Capital Digestive Care is the largest private gastroenterology practice in the Mid-Atlantic. Recent partnerships with Gastrointestinal & Liver Specialists of Tidewater and Gastroenterology, Ltd. in Southeastern Virginia have expanded its network to more than 160 physicians and advanced care practitioners who treat a wide range of conditions—from the common complaint of heartburn to the complex management of Crohn's Disease—and offer critical services for the prevention of colon cancer for more than 200,000 patients annually. With business operations located in Silver Spring, MD, Capital Digestive Care's integrated care model connects its doctors to more than 25 office locations and outpatient surgery centers as well as specialized laboratory services and the largest clinical research program of its kind in the region. For more information, please visit . Contact: Heather Shea +1 617-286-2013 [email protected] SOURCE Capital Digestive Care