Skip to main content
Premium Trial:

Request an Annual Quote

Epigenomics Completes Submission of CRC Test to FDA

NEW YORK (GenomeWeb News) – Epigenomics said today that it has completed the submission of its blood-based test for the detection of colorectal cancer for premarket approval by the US Food and Drug Administration.

The submission of the fourth and final module of its Epi proColon test last month included the results of a comparative, head-to-head study between this test and fecal immunochemical test screening, clinical validation study data, and other clinical study results that were generated during the test's development.

An Epigenomics test, based on the Septin9 protein, has been available as a CE-marked test kit in Europe and the Middle East since 2009, and, in 2011, it launched an improved version, the Epi proColon 2.0 CE.

"The non-inferiority of Septin9 to FIT demonstrated by the results of the head-to-head comparative study that were announced in Dec. 2012 was a very important milestone for us," Epigenomics' Acting CEO and CFO Thomas Taapken said in a statement.

"We continue to believe that our test is as effective as other non-invasive tests currently used with the added convenience of being a blood test, which will help drive screening compliance and therefore save more lives," Taapken added.

The Scan

Cell Atlas of Human Lung Development Gives View of Developing Airway

Researchers have generated a cell atlas of human lung development, which they report in Cell.

Study Finds Costs of Genome Sequencing May Limit Utility in Routine Care

Researchers report in the European Journal of Human Genetics that genome sequencing for rare disease diagnoses currently has similar benefits as less expensive exome analysis.

Study Suggests Nursing Mother's Diet Can Impact Offspring's Gut Microbiome

A new Cell Host and Microbe paper finds that mice whose mothers were fed a low-fiber diet during nursing experience lasting microbiota dysbiosis and increased obesity.

Study Links Genetic Risk for ADHD With Alzheimer's Disease

A higher polygenic risk score for attention-deficit/hyperactivity disorder is also linked to cognitive decline and Alzheimer's disease, a new study in Molecular Psychiatry finds.