Diagnostics
Application filed with FDA for colorectal cancer test
Published in Cancer Weekly, February 8th, 2005
AMDL, Inc., (ADL), 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), has submitted to the U.S. Food and Drug Administration, on behalf of AMDL, additional data and a new application for 510(k) clearance to market AMDL's DR-70 test as an aid in monitoring patients previously diagnosed with progressing colorectal cancer.
Specifically, DOCRO has submitted data showing that by using DR-70 in conjunction with the CEA test, which is the standard test for this disease, there is a 24% positive gain in positive concordance in monitoring the...
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Source: Cancer Weekly (2005-02-08)
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