RNA-Powered Molecular Test to Help Combat Early-Age Onset Colorectal Cancer

By LabMedica International staff writers
Posted on 10 May 2024

Image: ColoSense is the first FDA-approved RNA-based molecular screening test for qualitative detection of colorectal cancer (Photo courtesy of Geneoscopy)

Colorectal cancer (CRC) ranks as the second most lethal cancer in the United States. Nevertheless, many Americans eligible for screening do not undergo testing due to limited access or reluctance towards invasive methods like colonoscopies. Additionally, rising CRC incidence rates among individuals under 50 have led the United States Preventive Services Task Force to lower the recommended screening age to 45. Highlighting the severity of this issue, the American Cancer Society has recently declared CRC as the leading cause of cancer-related deaths among men and the second-leading cause among women under 50. This issue is further exacerbated by the fact that about 40% of those who are unscreened and eligible are between the ages of 45 and 49. Now, the U.S. Food and Drug Administration (FDA) has approved a noninvasive CRC screening test for adults, 45 years of age or older, who are at typical average risk for developing the disease.

Geneoscopy, Inc.’s (St, Louis, MO, USA) ColoSense, designated as a Breakthrough Device by the FDA, is the first noninvasive CRC screening test to provide a dynamic view of disease activity by utilizing RNA biomarkers. RNA biomarkers are advantageous as they are not influenced by age-related methylation patterns, which can affect test performance across different age groups. In order to evaluate ColoSense, the CRC-PREVENT trial by Geneoscopy assessed individuals aged 45 and older from diverse racial, ethnic, and socioeconomic backgrounds, employing a decentralized enrollment strategy. Remarkably, 64% of participants had never been screened for CRC, and 68% had not planned a colonoscopy at enrollment, differing from traditional trials that usually involve participants already engaged in health screening programs.

ColoSense demonstrated a 93% sensitivity rate for detecting CRC and importantly, identified all stage I CRC cases, where the disease is most treatable. It also detected 45% of advanced adenomas, which are more preventable stages of the disease. The study also found that the test achieved 100% sensitivity for CRC and 44% sensitivity for advanced adenomas among participants aged 45-49, emphasizing the importance of this screening age group. The FDA’s approval of ColoSense marks a significant advancement in making this vital screening tool accessible to patients. Geneoscopy is planning a commercial launch later this year or early in 2025 to ensure timely access to ColoSense for supporting CRC screening efforts.

“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,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “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.”

Related Links:
Geneoscopy, Inc.