The US Food and Drug Administration (FDA) has granted approval to Epigenomics’ blood-based colorectal cancer screening test, Epi proColon, making it the first and only FDA-approved colorectal cancer screening test.
Under a joint commercialisation agreement with the company’s strategic partner Polymedco, the screening test will be introduced in the US.
Epigenomics CEO and CFO Dr Thomas Taapken said: "While colorectal cancer remains the second-leading cause of cancer death in the US, one out of three eligible Americans still does not undergo colorectal cancer screening.
"Given the significant benefits for patients, healthcare professionals and payors, Epi proColon could help to meet the objective of 80% screening compliance of the eligible US population as pursued by US guideline bodies such as the American Cancer Society."
Epi proColon is an in-vitro polymerase chain reaction (PCR) assay to detect the septin9 gene methylation in DNA isolated from the patient’s plasma.
This can serve as an alternative for average-risk patients who do not choose to be administered with guideline-recommended methods such as a colonoscopy and stool-based fecal immunochemical tests (FIT).
The test is done only on a blood sample to be drawn from the patient during routine healthcare provider visits with no added dietary restrictions or alterations in medication required for the test.
The sample will be analysed at a local or regional diagnostic laboratory.
After securing the FDA approval, the company will begin a post-approval study to exhibit the long-term benefit of blood-based colorectal cancer screening using Epi proColon.