Colorectal Cancer Screening
Colorectal cancer (CRC) is the second deadliest cancer in the US, causing over 50,000 deaths annually.¹
Colorectal Cancer Screening
Colorectal cancer (CRC) is the second deadliest cancer in the US, causing over 50,000 deaths annually.¹ Leading organizations like the United States Preventive Service Task Force (USPSTF) and the American Cancer Society (ACS) recommend screening for average-risk individuals starting at age 45. However, millions of eligible patients often avoid screening due to unpleasant procedures or the perceived low risk of developing CRC compared to other cancers.
At Geneoscopy, our goal is to improve colorectal cancer screening with our multi-target stool RNA (mt-sRNA) biomarker panel, designed to detect precancerous lesions and cancer.
Based on the pivotal CRC-PREVENT trial results, Geneoscopy has received FDA approval for its innovative stool-based test (ColoSense®), reporting 93% sensitivity for CRC and 45% sensitivity for advanced adenomas.²
The results of Genesocopy’s CRC-PREVENT trial have been published in JAMA – The Journal of the American Medical Association.
The Power of RNA
Why choose RNA-based diagnostics? RNA is a dynamic and versatile molecule that shows real-time changes in the body. It is essential for protein synthesis, adjusts to disease conditions, and manages many genes in cellular processes. These changes in RNA pathways are associated with the start and progression of different cancers.
Our advanced RNA-centered approach uses the seRNA signal from epithelial cells shed in the GI tract, offering a thorough, uniform tissue sampling near a lesion. RNA-based biomarkers provide a concentrated, amplified signal across multiple transcripts in a pathway, potentially having the edge over DNA-based biomarkers. In addition, by evaluating the downstream effects of various precancerous mutations, RNA transcriptome analysis allows for accurate detection across all cancer development pathways.
CRC-PREVENT
The ColoRectal Cancer and PREcancerous adenoma noninvasive detectioN Test (CRC-PREVENT) trial demonstrated the efficacy of ColoSense®, Geneoscopy’s noninvasive, stool-based, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals.²
| Category | Efficacy Results |
|---|---|
| Sensitivity for CRC, Stage I-IV | 93% |
| Sensitivity for CRC, Stage I* | 100% |
| Sensitivity for AA | 45% |
| Specificity, defined as no lesions on a colonoscopy | 88% |
*12 of 12 cancers detected, 95% CI 77-100%
Based on the pivotal CRC-PREVENT trial results, Geneoscopy has received FDA approval for its innovative stool-based test ColoSense. The CRC-PREVENT study reported high levels of sensitivity for colorectal cancer and advanced adenoma detection for a noninvasive test in a pivotal trial. Notably, it was also the first study to report on CRC sensitivity for individuals aged 45-49, the most recent age range added to CRC screening guidelines.
The participants in the CRC-PREVENT study represent a more diverse range of socioeconomic and racial backgrounds than typically seen in clinical trials, better reflecting the country’s demographics. This diversity helps to confirm the test’s effectiveness across various groups and promotes the crucial aim of expanding access to CRC screening for populations that have been historically underserved.
With FDA approval, Geneoscopy looks forward to providing millions of eligible adults with ColoSense, an effective and simple option for detecting colorectal cancer and advanced adenomas.
References
- Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin 2022;72(1):7–33.
- Performance was assessed in a clinical study of 7,763 average risk patients. Additional information can be found on the FDA website:https://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230001
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