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AMDL, Inc.
U.S. FDA responds to submission for cancer test
July 6th, 2005
AMDL, Inc., (ADL), a developer and marketer of tests for the early detection of cancer and other serious diseases, announced that its consultant, Diagnostic Oncology Clinical Research Organization, (DOCRO) received a non-substantial equivalence letter from the U.S. Food & Drug Administration (FDA). The FDA pointed out several areas of concern in the recent adjunctive submission. AMDL believes that because AMDL has applied for approval of DR-70 as an adjunctive test to be used in conjunction with CEA (carcinoembryonic antigen) in monitoring colorectal cancer, substantial equivalence does not apply. The adjunctive submission from DOCRO showed that by...
Source: Biotech Week (2005-07-06)
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