Geneoscopy has enrolled the first subjects in the CRC-PREVENT clinical trial of its non-invasive, at-home diagnostic screening test to prevent colorectal cancers (CRC).
The RNA-FIT assay can potentially identify colorectal neoplasms, which includes advanced adenomas, in people at average risk.
No identified co-morbidities linked to cancer risk are seen in this group of individuals and such cancers are difficult to detect, Geneoscopy noted.
In January last year, the US Food and Drug Administration awarded breakthrough device status to the test.
The prospective, single-arm clinical trial will assess the safety and efficacy of Geneoscopy’s test in more than 12,000 subjects in the US.
For the trial, patients will provide samples through the mail and receive an optical colonoscopy examination.
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All substantial lesions detected during colonoscopy will be sent for biopsy or removed and undergo histopathological analysis.
To evaluate sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps and colonoscopies without findings, a comparative analysis will be conducted by the company.
Geneoscopy co-founder and chief scientific officer Dr Erica Barnell said: “We are pleased to initiate this important study and validate the use of Geneoscopy’s RNA-FIT assay as a valuable non-invasive tool to help prevent cancer through routine colorectal cancer screening.
“The ultimate goal of colorectal screening is cancer prevention, but this requires diagnostic screening options with the sensitivity to identify clinically relevant pre-cancerous lesions, including advanced adenomas.”
In a preliminary clinical trial, the multifactor RNA-FIT assay showed a high sensitivity when compared to colonoscopy findings. It had a sensitivity of 95%, 62% and 25% for colorectal cancer, advanced adenomas and other non-advanced adenomas, respectively.
Furthermore, the test demonstrated a specificity of 85% as against no findings on a colonoscopy.
CRC is the second main cause of cancer death in the US, with colonoscopy being the gold standard for CRC screening.