Epigenomics has reported positive results from a clinical study, which showed that its blood-based colorectal cancer (CRC) detection test is non-inferior in sensitivity when compared to fecal immunochemical testing (FIT).
Using patients blood samples, instead of stool samples, non-invasive Epi proColon test screens CRC patients.
Randomized in two arms, the double blind study’s 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 the second arm including198 individuals’ blood and stool samples were collected before the colonoscopy.
In addition, the study arm 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."