NEW YORK (GenomeWeb News) – Epigenomics today announced it has submitted the third of four modules to US regulators for possible approval of its Epi proColon blood-based colorectal cancer screening test.
The German molecular diagnostics company said it expects to submit the fourth and final module to the US Food and Drug Administration in the second half of this year.
The third module describes the analytical performance of Epi proColon in terms of accuracy, precision, and stability. Testing was performed at three external laboratories to assess reproducibility and validation of the analytical performance.
The first two modules of the premarket approval submission to FDA described design control, manufacturing, quality management, and software validation for the test. The first module was submitted in January and the second module was submitted in March.
The fourth module will include results of a head-to-head comparison to indicate that Epi proColon performs equally as well as fecal immunochemical testing. The clinical trial is required for regulatory submission. Epigenomics said the study is underway and patients are being enrolled.
The last module will also include previously announced data from a clinical validation study in a cohort of prospectively collected samples and other clinical study results.