Summary: Geneoscopy received FDA approval for ColoSense, a noninvasive colorectal cancer screening test using RNA biomarkers designed for adults at risk for colorectal cancer (CRC).

Takeaways:

  1. ColoSense is a noninvasive test that utilizes RNA biomarkers to dynamically monitor colorectal cancer, avoiding age-related methylation issues that can affect test accuracy across different age groups.
  2. In clinical trials, ColoSense demonstrated a high sensitivity for detecting CRC, including a 100% detection rate for Stage I CRC, making it a potent tool for early diagnosis and potentially increasing the accessibility of CRC screening.
  3. Geneoscopy says it will launch the ColoSense test in collaboration with Labcorp.

Geneoscopy, a company focused on developing diagnostic tests for gastrointestinal health, announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.

Noninvasive Colorectal Cancer Test 

Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups. (1-2)

“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,” says 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.”

ColoSense Clinical Trial

Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. 

This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.

Colorectal Cancer in the U.S.

Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force’s guidelines to recommend initiation of CRC screening at age 45.(3) 

Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.4 Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.(5,6)

Further reading: Researchers Identify the Critical Gap in Colorectal Cancer Screening

“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It’s essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” says Anjee Davis, president of Fight CRC. “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.”
FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp.