Geneoscopy, a gastrointestinal health-focused life sciences company, has received the US Food and Drug Administration (FDA) approval for its ColoSense, a colorectal cancer (CRC) screening test.
ColoSense is a non-invasive multi-target stool RNA (mt-sRNA) test for colorectal cancer screening.
It is designed to detect colorectal neoplasia-associated RNA markers and occult haemoglobin in human stool.
The single-site test is indicated for individuals aged 45 years or older, who are at typical average risk for developing CRC.
ColoSense, recognised as a Breakthrough Device by the FDA, is said to be the first such test to offer a dynamic view of disease activity using RNA biomarkers.
Additionally, the CRC test is not affected by age-related methylation patterns, ensuring consistent performance across diverse age demographics, Geneoscopy claimed.
Geneoscopy CEO and co-founder Andrew Barnell said: “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.
“This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”
The life sciences company assessed the test on individuals aged 45 and above in the CRC-PREVENT trial.
It enrolled participants who had never undergone colorectal cancer screening and adults who had not scheduled a colonoscopy upon enrolment.
Among average-risk individuals, ColoSense achieved 93% sensitivity for detecting CRC and notably identified all Stage 1 CRC cases, the most treatable stage of the disease.
In addition, the screening test detected 45% of advanced adenomas, the stage at which the disease is most preventable.
Furthermore, the study highlighted ColoSense’s effectiveness in patients aged 45-49, reporting a 100% sensitivity for CRC and 44% sensitivity for advanced adenomas.
The test is expected to be commercially available later this year or early in 2025.
Geneoscopy signed a multi-year agreement with Labcorp in November last year to distribute ColoSense in the US.
