Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
ST. LOUIS--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation. 1,2
The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care.
'The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,' said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. 'As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.'
ColoSense's inclusion in the NCCN Guidelines is based on data from Geneoscopy's CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA). 3 Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense's ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable.
'The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,' said Matt Sargent, Chief Commercial Officer of Geneoscopy. 'Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.'
About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.
About Geneoscopy, Inc.
Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. 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.
References
Ahlquist, D. A., Taylor, W. R., Yab, T. C., Devens, M. E., Mahoney, D. W., Boardman, L. A., Thibodeau, S. N., Zou, H., Michael, D., Berger, B. M., & Lidgard, G. P. (2012). Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research, 72(8_Supplement), 3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572
Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. (2012) Aberrantly Methylated Gene Marker Levels in Stool: Effects of Demographic, Exposure, Body Mass, and Other Patient Characteristics. J Mol Biomark Diagn 3:133. doi:10.4172/2155-9929.1000133
Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760–1768. doi:10.1001/jama.2023.22231
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Newsweek
34 minutes ago
- Newsweek
Egg Recall Map Shows Warnings Issued to Customers in 9 States
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. August Egg Company has issued a recall on Friday for 1,700,000 brown cage-free and certified organic brown eggs due to potential fears of salmonella. Newsweek reached out to the company after hours via phone Friday night for comment. Why It Matters Numerous recalls have been initiated this year due to the potential for the following: damaged products, foodborne illness, contamination and undeclared food allergens. Millions of Americans experience food sensitivities or food allergies every year. According to the Food and Drug Administration (FDA), the nine "major" food allergens in the U.S. are eggs, milk, fish, wheat, soybeans, Crustacean shellfish, sesame, tree nuts and peanuts. The FDA warns that salmonella is an organism that could cause serious and sometimes fatal infections in frail or older people, young children and those with weakened immune systems. What To Know The FDA says in its alert that some of the eggs were distributed to grocery stores including Save Mart, FoodMaxx, Lucky, Smart & Final, Safeway, Raleys, Food 4 Less and Ralphs. Those eggs were distributed from February 3, 2025, to May 15, 2025, with sell by dates of March 4, 2025, and June 4, 2025, in both California and Nevada. The FDA says additional eggs were distributed from February 3, 2025, to May 6, 2025, with sell by dates of March 4, 2025, and June 19, 2025, in Walmart stores in Illinois, Indiana, Nebraska, New Mexico, California, Washington, Nevada, Arizona and Wyoming. The plant code numbers for the recalled eggs can be found printed on the package and are P-6562 or CA5330 with Julian Dates from 32 to 126, the FDA says. The Julian Dates are codes of three to seven digits and represent the date that the food was packaged or manufactured. "This recall is associated with an ongoing outbreak investigation of Salmonella Enteritidis illnesses" the alert says, adding the investigation is related to products distributed in the nine states. The FDA alert also has a chart of the Julian Dates with corresponding item names. What People Are Saying The FDA alert, in part: "August Egg Company is not selling fresh shell eggs at this time. Our firm has voluntarily been diverting eggs to an egg-breaking plant for over 30 days, which pasteurizes the eggs and kills any potential foodborne pathogens." August Egg Company in the FDA alert: "August Egg Company of Hilmar, CA is voluntarily recalling 1,700,000 dozen shell eggs processed at our California plant and sold to various grocery customers. This recall has been initiated due to possible Salmonella enteritidis contamination, which poses a health risk. With that in mind, we believe it is appropriate out of an abundance of caution to conduct this voluntary recall, as consumers may still have these eggs in their homes. "It is important to know that when our processing plant identified this concern, we immediately began diverting all eggs from the plant to an egg-breaking facility, which pasteurizes the eggs and kills any pathogens. "August Egg Company's internal food safety team also is conducting its own stringent review to identify what measures can be established to prevent this situation from recurring. We are committed to addressing this matter fully and to implementing all necessary corrective actions to ensure this does not happen again." What Happens Next Customers with additional questions can call August Egg Company at 1-800-710-2554 from 9 a.m. and 5 p.m. PT and can also return the eggs to the original place of purchase for a refund.
Yahoo
an hour ago
- Yahoo
H.C. Wainwright Reiterates Buy Rating on Immix Biopharma (IMMX) Following Promising Interim Results from NXC-201 Trial
On June 4, analyst Robert Burns of H.C. Wainwright reiterated a Buy rating on Immix Biopharma, Inc. (NASDAQ:IMMX) with a price target of $7.00. The analyst based the rating on the promising interim results from the NEXICART-2 Phase 1/2 clinical trial of NXC-201, presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois. The trial assessed the efficacy of NXC-201 in patients with relapsed/refractory AL amyloidosis and delivered a 100% response rate, with a considerable portion attaining a complete hematologic response. The analyst reasoned that the absence of hematologic relapse or progression and the rapid mean time to response further highlight NXC-201's potential as a viable treatment. A doctor in a white coat discussing clinical trial results with a patient in an oncology practice. Burns also reasoned that NXC-201 appears to have a favorable safety profile, as no patients experienced severe cytokine release syndrome or neurotoxicity. While he highlighted the need for longer-term follow-up and the small sample size, the analyst stated that the interim results are promising when compared to existing treatments. This condition does not have FDA-approved agents, and there exists a fragmented treatment landscape post-frontline therapy, factors that suggest the notable market opportunity for NXC-201 and support the buy rating for Immix Biopharma, Inc. (NASDAQ:IMMX). Immix Biopharma, Inc. (NASDAQ:IMMX) is a biopharmaceutical company that develops therapies for inflammatory diseases and cancer. While we acknowledge the potential of IMMX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. Sign in to access your portfolio
Yahoo
an hour ago
- Yahoo
Jefferies Maintains Buy Rating on Rhythm Pharmaceuticals (RYTM), Sets $80 Price Target
In a report released on June 4, Dennis Ding from Jefferies maintained a Buy rating on Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) with a price target of $80.00. The analyst based the rating on the company's strategic developments and promising pipeline. One of the primary reasons behind the rating was the anticipated Phase II data for the oral treatment for hypothalamic obesity (HO). It is expected to deliver notable BMI reduction and has been de-risked, thereby extending the potential of the franchise beyond the current expiration dates. A scientist conducting research in a laboratory, studying a Petri dish with advanced biopharmaceuticals. The analyst stated that management is confident in the weekly subcutaneous (subQ) treatment, which closely aligns with the previously approved setmelanotide, and thus further adds to the positive outlook for Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM). According to Ding, the setmelanotide Phase II open-label trial for Prader-Willi Syndrome can also pave the way for a significant opportunity if successful, even after its previous challenges. Management is focusing on patient starts instead of the immediate revenue post-launch, and this strategy supports the long-term growth prospects, according to the analyst. Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) is a commercial-stage biopharmaceutical company that develops and commercializes therapeutics for the treatment of rare diseases. Its product pipeline includes IMCIVREE (setmelanotide), a precision medicine that treats hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) diseases. The company also has other programs, including a preclinical suite of investigational candidates to treat congenital hyperinsulinism and a clinical development program for setmelanotide in other rare MC4R pathway diseases. While we acknowledge the potential of RYTM as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None.
