FDA approves ColoSense stool RNA test to detect colorectal cancer in average-risk adults
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The FDA has approved Geneoscopy Inc.’s ColoSense multitarget stool RNA test for adults aged 45 years or older at average-risk for developing colorectal cancer, according to a company press release.
Previously granted FDA breakthrough device designation in January 2020, ColoSense is the “first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers,” Geneoscopy noted in the release.
“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,” Andrew Barnell, CEO and co-founder of Geneoscopy, said in the release. “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 agency based its decision on data from the CRC-PREVENT study, which assessed more than 1,800 average-risk patients aged 45 to 49 years from different racial, ethnic and socioeconomic backgrounds.
According to study results, among all average-risk patients, ColoSense demonstrated 93% sensitivity for CRC and 45% sensitivity for advanced adenomas; notably, 100% of identified CRC were stage I. In a subset of patients aged 45 to 49 years, ColoSense demonstrated an improved sensitivity of 100% for CRC and a consistent 44% sensitivity for advanced adenomas.
“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening,” Anjee Davis, president of Fight CRC, said in the release. “It’s essential to eliminate obstacles and broaden the availability of screening methods for health care providers and patients. We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”
Geneoscopy plans to launch ColoSense in collaboration with Labcorp either late in 2024 or early 2025, and noted that the company is currently working with payors, professional societies and advocacy partners “to ensure patients have timely access to ColoSense to support CRC screening.”
Perspective
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Brenda Jimenez, MD
CRC is the third most diagnosed cancer and the second most common cause of cancer death in the United States. It is an excellent candidate for screening as it is preventable if precancerous lesions are identified and removed. It is also treatable, with higher success rates if found early.
The population at risk includes adults aged 45 and older. However, among adults who qualify for screening, the prevalence of screening is approximately 59% and ranges from 53% to 70% nationwide. Screening is lowest — approximately 20% — among individuals aged 45 to 49 years.
CRC screening options include stool-based testing and visual examinations, including colonoscopy and CT colonography. Colonoscopy is the most common test in the U.S., with the lowest prevalence in those aged 45 to 49 years (18%). In this age group, incidence rates have been increasing by 2% per year since 2011. This increase has led to multiple societies lowering the recommended age to start CRC screening from 50 years to 45 years.
The availability of more than one screening test that is sensitive in the detection of precancerous lesions and early-stage lesions is paramount in increasing the prevalence of CRC screening.
This study presents data from a large, population-based trial in which individuals at average risk for CRC were screened with a novel RNA-based stool test. It is the first RNA-based stool test that will be available.
In addition, it included individuals aged 45 to 49 years, which had not been included in previous studies given the recent change in the guidelines to start screening at age 45. The test showed high sensitivity for CRC and sensitivity that was comparable to other stool-based tests for advanced precancerous lesions, and represents another helpful tool to offer to patients when discussing CRC screening options.
Reference:
Colorectal cancer facts & figures 2023-2025. https://www.cancer.org/research/cancer-facts-statistics/colorectal-cancer-facts-figures.html.
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