FDA approves Geneoscopy's ColoSense test for CRC screening [Yahoo! Finance]
Laboratory Corporation of America Holdings (LH)
Last laboratory corporation of america holdings earnings: 4/29 06:53 am
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Source: Yahoo! Finance
The ColoSense test is designed to detect colorectal neoplasia-associated RNA markers and occult haemoglobin in human stool. The test, which is to be used with the ColoSense Collection Kit, Test Kit and Software, as well as specific instruments, is performed at a single site at Geneoscopy. ColoSense has been designated as a breakthrough device by the FDA and is said to be the first to utilise RNA biomarkers for a dynamic view of disease activity. The CRC-PREVENT trial, which included participants from diverse backgrounds, showed that ColoSense had a 93% sensitivity for CRC detection and a 45% sensitivity for advanced adenomas (AA) detection in average-risk individuals. Furthermore, the trial highlighted a 100% sensitivity rate for CRC in the age group of 45-49 years, which is significant for early-age onset CRC prevention. Geneoscopy CEO and co-founder Andrew Barnell said: “Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that
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