German-American cancer molecular diagnostics company Epigenomics’ blood-based colorectal cancer (CRC) detection test was found to be non-inferior in sensitivity to fecal immunochemical testing (FIT) in a comparative study.
The non-invasive Epi proColon detection test uses patients’ blood samples, instead of stool samples, for screening CRC.
Performed at 70 clinical trial sites across the US, the double-blind study has randomised patients in two arms.
The first arm included a total of 103 asymptomatic patients having average risk of CRC, without family history or previous incidences of CRC, who were diagnosed and confirmed as having CRC during a screening colonoscopy.
The blood and stool samples from the first arm patients were collected at least 10 days after colonoscopy but before surgical intervention, while in the second arm 198 individuals’ blood and stool samples were collected before the colonoscopy.
The study arm also included three cancer cases as well as advanced adenomas, polyps and individuals with no evidence of disease, according to the company.
The study found higher sensitivity of 71% in Epi proColon, compared to sensitivity of 67% in FIT, as well as lower specificity of 81% in comparison to FIT at 98%.
The company said it will use the positive study data in its final module of the premarket approval (PMA) application, which is expected to be filed with the FDA before the end of the December 2012.
Epigenomics chief operating officer Dr Uwe Staub said; "We look forward to an active dialogue with the agency upon completion of our PMA filing before the end of this year."