Previous studies have shown that a first generation fDNA test (PV1) was effective in the detection of colon cancer but partial degradation of DNA was a limitation. Using a second-generation test, the research team, led by Dr. Steven Itzkowitz, primary goal was to determine the sensitivity (SENS) and specificity (SPEC) of the new test in patients with known CRC and those with normal colonoscopies (NL). Compared to PV1 data, the addition of buffer and gel-capture technology, as well as new markers of colon cancer, increased test sensitivity for cancer detection to 88%.
"This is an exciting achievement for this technology. Fecal DNA testing has already shown promise for non-invasive tool for colon cancer detection. But, we can now say this test is more sensitive which ultimately means better results for the clinician and the patient. Better tests mean greater detection and less loss of life," said Steven Itzkowitz, M.D., Professor and Associate Director of Gastroenterology at The Mount Sinai Medical Center. "The fact that the new version of the test includes fewer markers makes the new test even easier to perform."
Patients in this prospective multi-center study were enrolled and consented after colonoscopic findings of either a normal colon (n=122) or CRC (n=40). Patients had no personal or family history of CRC or polyps. Approximately 6-14 days after colonoscopy (prior to surgery for the CRC group), patients submitted a single stool sample to which they had immediately added buffer and then shipped the specimen by express courier to the clinical lab. Stools were homogenized and DNA was extracted using sequence-specific gel-capture.