The US Food and Drug Administration (FDA) has approved an improved stool collection kit of Geneoscopy鈥檚 RNA-based colorectal cancer (CRC) screening test, ColoSense.
The new kit enhances user convenience by eliminating the need for patients to separate their stool sample into various containers, while maintaining the test’s clinical performance and streamlining the at-home testing process.
ColoSense is designed for people aged 45 years and above who are at average CRC risk. The test employs advanced RNA technology to identify biomarkers for CRC and advanced adenomas (AA), which are precancerous lesions with the potential to develop into cancer if not treated.
It claims to be the only RNA-based test approved by the FDA for CRC screening, showing a 93% sensitivity rate for CRC and 45% for AA in average-risk subjects.
For those between the ages of 45 and 49, a demographic experiencing an increase in CRC incidence, ColoSense claims to have shown a complete sensitivity rate for detecting CRC and 44% sensitivity for AA.
Geneoscopy chief medical and science officer Dr Erica Barnell said: 鈥淲e鈥檝e taken a critical step toward improving the at-home colorectal cancer screening experience by removing one of the most burdensome aspects for patients鈥攖he scraping of stool.
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By GlobalData鈥淭he new collection kit simplifies the process for collecting a patient鈥檚 stool sample. By eliminating the most confusing and undesirable step, we believe ColoSense will drive higher adherence and better outcomes.鈥�
The National Comprehensive Cancer Network (NCCN) has included ColoSense in its guidelines.
Through a strategic partnership with Labcorp, Geneoscopy aims to widen ColoSense’s availability, thereby increasing access for healthcare providers and patients across the US.
While ColoSense is a screening test for adults aged 45 years or older at typical average risk for CRC, it is not intended to replace diagnostic or surveillance colonoscopy in high-risk subjects.
