ColoSense™ Multi-Target Stool RNA (mt-sRNA) Non-Invasive Colorectal Cancer Screening Test Approved By FDA

ColoSense™ Multi-Target Stool RNA (mt-sRNA) Non-Invasive Colorectal Cancer Screening Test Approved By FDA

Colorectal Cancer

In a press release (dated 6 May 24), Geneoscopy, Inc., a life sciences company based in the US, announced that the U.S. Food and Drug Administration had (FDA) approved its (stool-based) non-invasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC. Colorectal cancer is one of the most deadly forms of cancer in Singapore.

Non-Invasive Colorectal Cancer Screening Test Using RNA Biomarkers

Geneoscopy describes ColoSense as “the first non-invasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers”. The advantage of RNA biomarkers is that they are not subject to age-related influences that may lead to variability in test performance across different age groups.

Geneoscopy’s clinical trial involving participants aged 45 and older from different racial, ethnic, and socioeconomic backgrounds. It was found that in average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for colorectal cancer (i.e. less likely to miss the cancer if it is present) and “importantly identified 100% of colorectal cancer in Stage I, when the disease is most curable”. ColoSense was also able to detect 45% of advanced adenomas. These are a type of colorectal polyps that may lead to colorectal cancer.

Future Option For Non-Invasive Colorectal Cancer Screening In Singapore

Colorectal cancer is one of the most deadly cancers in Singapore. Furthermore, globally, there is a trend of increasing incidence in younger populations. While a colonoscopy remains the gold standard for colorectal cancer screening, the cost and invasive nature of the procedure may be factors deterring people from this potentially life-saving screening. This may cause patients to miss out on timely treatment while the cancer is in the early stages and easiest to treat.

The common non-invasive screening for colorectal cancer currently is the FIT test. ColoSense has a higher degree of sensitivity based on trial results and if it becomes available for use in Singapore in time, it may be an important additional tool in the fight against colorectal cancer.

Colorectal Cancer Screening In Singapore

Learn more about colorectal screening in Singapore in our article. Schedule a colonoscopy if you are aged 50 and above, or if you have an increased risk for colorectal cancer (e.g. family history).

Additional Information From Geneoscopy Press Release

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, 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 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. 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.

Protect against cancer, cardiovascular disease, and other chronic diseases with regular health screening. Compare and shop for health screenings from Singapore and regional healthcare providers at a single convenient platform - shop.health365.sg

This article is informative only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment, and should never be relied upon for specific medical advice.

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