ColoSense Colorectal Cancer Screening Test Gets FDA Approval

The US Food and Drug Administration (FDA) has approved ColoSense, a noninvasive colorectal cancer screening test, for adults 45 years of age and older who are at average risk of developing colorectal cancer.

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. A positive result should be followed up with colonoscopy.

The approval was based on data from the blinded, prospective phase 3 CRC-PREVENT trial (ClinicalTrials.gov Identifier: NCT04739722). The trial was designed to compare ColoSense to colonoscopy in patients 45 years of age and older.

Of the 8920 trial participants, 64% had never been screened for colorectal cancer, and 68% had not scheduled a colonoscopy at the time of enrollment.

Colorectal cancer was detected in 36 (0.4%) patients, and advanced adenomas were identified in 606 (6.8%) patients.

The sensitivity of ColoSense was 94% for detecting colorectal cancer (34 of 36 patients) and 100% for identifying stage 1 colorectal cancer (n=14). The sensitivity of ColoSense for detecting advanced adenomas was 46% (278 of 606 patients).

In patients 45 to 49 years of age, the sensitivity of ColoSense was 100% for colorectal cancer and 45% for advanced adenomas. 

Findings also showed the specificity of ColoSense for no lesions on colonoscopy was 88%, similar to existing molecular diagnostic tests.

ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. The single-site test is performed at Geneoscopy, Inc. ColoSense is expected to launch in collaboration with Labcorp later this year or in early 2025.

This article originally appeared on MPR