ColoTest®, an over-the-counter (OTC) at-home immunochemical fecal occult blood test, has been available by Reese Pharmaceutical.
ColoTest is designed to detect blood in the stool, which may be an early indication of colorectal cancer, diverticulitis, gastrointestinal disorders, colitis or polyps. Each test includes a guide, an insert, a test cassette, a sample collection tube, and a collection paper.
After collecting a stool sample, the test specimen is dispensed into the sample well of the test cassette. If the sample contains a concentration of human hemoglobin antibodies at or above 50ng/mL, the test line becomes visible indicating that the sample contains a detectable level of blood; the assay reading time is between 1 and 10 minutes.
If blood is detected, the patient should follow-up with a colonoscopy. The sensitivity (true positive) and specificity (true negative) of fecal immunochemical tests for detecting cancer were reported to be 73.8% and 96.4%, respectively.
ColoTest is available in 1- and 2-count test kits. The retail price for a 1 test is $19.99.
References:
Reese Pharmaceutical launches new at-home colon cancer screening test. News release. Reese Pharmaceutical. February 27, 2024. https://www.prnewswire.com/news-releases/reese-pharmaceutical-launches-new-at-home-colon-cancer-screening-test-302070648.html.