FDA Approves ColoSense™ – Geneoscopy's Noninvasive Multi-target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test
Laboratory Corporation of America Holdings (LH)
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Source: Business Wire
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. ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive 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.Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a d
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