Epi proColon 2 regulatory update

Epigenomics said it received a response letter from FDA for a PMA for its Epi proColon 2.0 blood-based colorectal cancer (CRC) screening test. The company said FDA requested additional data demonstrating the test would increase compliance for CRC screening in patients who do not undergo screening by recommended methods, such as colonoscopy or fecal immunochemical testing (FIT). The company expects it will need to conduct an additional trial to address the agency's requests because the originally conducted trials were performed in patients who had agreed to routine colonoscopy screening. Epigenomics has scheduled a meeting with FDA at the end of June to discuss next steps, including details around an additional trial.

In March, the Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted 5-4, with 1 abstention, that the benefits of Epi proColon 2.0 outweigh the product's risks (see BioCentury, March 31). Epi proColon 2.0 is a second-generation test that uses real-time PCR to detect methylated DNA of the Septin 9 gene in blood plasma. Epigenomics markets the test in Europe. ...