Epigenomics has announced results from a comparative study between its blood-based colorectal cancer(CRC)detection test Epi proColon and fecal immunochemical testing(FIT)to demonstrate the non-inferiority of Epi proColon in detection of CRC.
Epigenomics chief financial officer and acting chief executive officer Thomas Taapken said based on the achieved non-inferiority in CRC detection,the company believes that Epi proColon has demonstrated its value to be a convenient non-invasive test alternative for CRC detection.
''Bringing a blood-based non-invasive product like Epi proColon?to the market will significantly drive awareness for colorectal cancer screening among individuals that would otherwise be noncompliant,since current compliance to FIT testing remains at low levels,"Taapken added.
The comparative study demonstrated that Epi proColon detected 73 in a total of 103 evaluable samples from patients with colorectal cancer while the FIT comparator detected 66 out of 98 cancer cases for which stool samples were provided.
Epigenomics will use the study results for Epi proColon's final module of the Premarket Approval(PMA)submission,which is expected to be filed with the US Food and Drug Administration(FDA)before the end of 2012.
The double blind study was performed at 70 clinical trial sites across the US and comprised two arms,consisting of 301 patients totally.
Epigenomics chief operating officer Uwe Staub said,"These positive study results confirm the performance of our assay and indicate that Epi proColon?is non-inferior to FIT in the detection of CRC.''
