Geneoscopy secured FDA approval in May 2024 for ColoSense in adults aged 45 years and older. Credit: mentalmind via Shutterstock.

Data has been published demonstrating the analytical validation of Geneoscopy’s ColoSense, a non-invasive multi-target stool RNA (mt-sRNA) test for colorectal cancer (CRC) screening. 

In the study, published in The Journal of Molecular Diagnostics, researchers evaluated 12 validation studies. Looking at different parameters such as analytical sensitivity, linearity, precision, and robustness, the study indicated that the test detects low levels of specific RNA markers and maintains accuracy across a wide range of testing conditions.

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The analytical validation studies were part of the pre-market approval application to the US Food and Drug Administration (FDA). Geneoscopy secured FDA approval in May 2024 for ColoSense in adults aged 45 and older.

Distributed alongside LabCorp, the ColoSense test is designed to detect colorectal neoplasia-associated RNA markers and occult haemoglobin in human stool. The prescription-only test gets shipped to the patient’s home. Once the patient deposits a stool sample, they ship the test back to Geneoscopy.

Geneoscopy previously shared results from the CRC-PREVENT trial (NCT04739722), showing that ColoSense had a 93% sensitivity for CRC detection and a 45% sensitivity for advanced adenomas (AA) detection in average-risk individuals. The Phase III trial evaluated 8,920 participants aged 45 and older. The US-based company secured $105m in Series B funding in November 2021 to support the trial.

CRC is one of the most common cancers worldwide and is increasing in prevalence in adults under 50. Data from the CRC-PREVENT trial highlighted that ColoSense’s sensitivity for CRC was found to be 100% in younger participants aged between 45 and 49 years. If more countries follow in the footsteps of the US and drop screening ages to 45 years or younger, the CRC test market will expand to accommodate a larger test population, according to GlobalData analyst Selena Yu.  

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 GlobalData analysis estimates that the CRC screening market will generate $129.4m by 2030. 

Erica Barnell, chief science and medical officer at Geneoscopy said: “These study results position us to continue advancing diagnostic technologies that will help meet the growing demand for reliable and accessible cancer screening solutions for the 44 million Americans at average risk for CRC.”

In March 2024, US-based Exact Sciences Corp reported that a study had been published in The New England Journal of Medicine, detailing how the use of its Cologuard Plus device saw a 94% sensitivity for CRC at 91% specificity.