FDA Approval Sought for Colorectal Cancer Monitoring Test

AMDL, Inc. has filed with the U.S. Food & Drug Administration for clearance to market its unique DR-70® tumor marker test for use as an aid in monitoring patients previously diagnosed with colorectal cancer.

DR-70, an in vitro diagnostic test for the DR-70 antigen in human serum, has shown promising results in clinical trials. "We have forwarded to the FDA the data that we believe will show the efficacy and safety of our test," said Gary L. Dreher, President..

AMDL said it believes the test will be useful as an aid in monitoring colorectal cancer cancer patients throughout the course of the disease, including after primary surgery, and in determining the response to therapy.

"FDA clearance to market will be a major step for AMDL in the acceptance of DR-70 not only in the U.S. but worldwide," Dreher said.

Other sources: AMDL