FDA Grants Clearance for Colorectal Cancer Blood Test

The FDA gave AMDL clearance to market its AMDL-ELISA DR-70 as a blood test for patients who have been previously diagnosed with colorectal cancer.

The clearance was based on data confirming that the assay can monitor progression of the disease in patients who have had surgery.

The test is cleared in Canada for lung cancer detection. As a general cancer screen, it has received CE Marking from the EU and has been cleared for import to Korea and Taiwan, the company said.