NEW YORK – Oncology diagnostics firm Geneoscopy said Tuesday that the US Food and Drug Administration has approved its noninvasive, stool-based colorectal cancer screening test, ColoSense.
The assay is indicated for screening of individuals at least 45 years old who have an average risk for developing colorectal cancer.
ColoSense looks for fecal hemoglobin and for RNA biomarkers, which the company said are not affected by age-related methylation that can lead to varying test performance in different age groups.
The firm's CRC-PREVENT trial evaluated a diverse cohort of participants aged 45 and older. In these average-risk individuals, the test demonstrated 93 percent sensitivity for CRC with 100 percent detection of stage I tumors. The assay also detected 45 percent of advanced adenomas, a risky cancer precursor lesion that clinical screening aims to identify and remove to improve patient outcomes.
The same study also reported 100 percent CRC sensitivity and 44 percent advanced adenoma sensitivity in patients aged 45 to 49 years, a relatively new arm of screening-eligible patients, who some have suggested may be particularly attracted to alternatives to colonoscopy, which remains the gold standard.
"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," Geneoscopy CEO Andrew Barnell said in a statement.
The St. Louis-based company aims to launch the PCR test commercially later this year or in early 2025 in partnership with the Laboratory Corporation of America.
It is likely going to compete with Exact Sciences' Cologuard, also a stool-based CRC screening test that looks for DNA point mutations, DNA methylation markers, and fecal hemoglobin.