FDA Approves ColoSense™ – Geneoscopy's Noninvasive Multi-target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test
- In average-risk individuals, ColoSense demonstrated 93% sensitivity for detecting colorectal cancer (CRC) and 45% sensitivity for detecting advanced adenomas (AA).
- The CRC-PREVENT study evaluated more than 1,800 average-risk individuals aged 45-49, representing over 20% of participants. Results in this subgroup showed 100% sensitivity in detecting CRC and 44% sensitivity for AA, offering a promising new tool to combat early-age onset CRC.
Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.1-2
“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said
Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.
Colorectal cancer is the second deadliest cancer in
“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It's essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said
FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with
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
A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the
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References:
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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
- Mehta SJ, Morris AM, Kupfer SS. Colorectal Cancer Screening Starting at Age 45 Years—Ensuring Benefits Are Realized by All. JAMA Netw Open. 2021;4(5):e2112593. doi:10.1001/jamanetworkopen.2021.12593
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American Cancer Society https://pressroom.cancer.org/acs-cff-2024 -
Hyams T, Mueller N, Curbow B, King-
Marshall E , Sultan S. Screening for colorectal cancer in people ages 45-49: research gaps, challenges and future directions for research and practice. Translational Behavioral Medicine. 2022;12(2):198–202. https://doi.org/10.1093/tbm/ibab079 - US Census data, Geneoscopy estimates (includes US markets only)
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