AMDL to Meet With FDA Concerning DR-70 Submission

AMDL said its consultant, Diagnostic Oncology Clinical Research Organization (DOCRO), received a nonsubstantial equivalence letter from the FDA.

AMDL has applied for approval of the DR-70 noninvasive cancer blood test as an adjunctive test to be used in conjunction with carcinoembryonic antigen (CEA) in monitoring colorectal cancer. The FDA had pointed out several areas of concern in the adjunctive submission, which showed that by using DR-70 in conjunction with the CEA test there is a significant gain in positive concordance of 24 percent for monitoring the progression of the clinical disease status in previously diagnosed colorectal cancer patients as compared to using the CEA test by itself.

DOCRO has sent a response and set up a meeting with the FDA and AMDL to discuss the FDA's specific concerns, which must be favorably resolved to advance the regulatory process.