AMDL Files New Application With FDA
January 06 2005 - 2:47PM
PR Newswire (US)
AMDL Files New Application With FDA TUSTIN, Calif., Jan. 6
/PRNewswire-FirstCall/ -- AMDL, Inc. (AMEX:ADL), developer and
marketer of tests for the early detection of cancer and other
serious diseases, today 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(R) test as an aid in monitoring patients
previously diagnosed with progressing colorectal cancer.
Specifically, DOCRO has submitted data showing that by using
DR-70(R) in conjunction with the CEA test, which is the standard
test for this disease, there is a 24 percent positive gain in
positive concordance in monitoring the progression of the clinical
disease status in previously diagnosed colorectal cancer patients
as compared to using the CEA test by itself. The CEA
(carcinoembryonic antigen) test has sensitivity that varies from 40
to 70 percent, according to published literature. The additional
data supports the new 510(k) adjunctive claim that AMDL's DR-70(R),
when used in tandem with the CEA test, provides more accurate
information in monitoring colorectal cancer patients. About AMDL
AMDL, Inc. (AMEX:ADL), headquartered in Tustin, California, is a
theranostics company, involved in the detection and treatment of
the same disease, cancer. AMDL is the inventor, developer and
worldwide marketer through exclusive distribution agreements of the
DR-70(R) non-invasive cancer blood test, which has demonstrated its
ability to detect the presence in humans of up to 13 cancers 84
percent of the time overall. In a study published in the Journal of
Immunoassay (1998, vol. 19, pp 63-72) DR-70(R) was shown to detect
at least 13 different types of cancer (lung, breast, stomach,
liver, colon, rectal, ovarian, esophageal, cervical, trophoblastic,
thyroid, malignant lymphoma, pancreatic) although the sample size
for 9 of the cancers was not statistically significant. Clinical
trials of DR-70(R) have been conducted in Canada, China, Germany,
Taiwan and Turkey. DR-70(R) can detect many kinds of cancer using a
single tube of blood, eliminating the need for costly, multiple
tests. AMDL also owns a combination immunogene therapy technology
that is a possible treatment for those already diagnosed with
cancer and could eventually be used as a vaccine to protect
patients known to be at risk because of a family history for
certain types of cancer. The combination therapy both builds the
body's immune system and destroys cancer cells. More information
about AMDL and its additional products can be obtained at
http://www.amdlcorporate.com/. Forward-Looking Statements
Statements in this press release may constitute forward-looking
statements and are subject to numerous risks and uncertainties,
including the failure to complete successfully the development of
new or enhanced products, the Company's future capital needs, the
lack of market demand for any new or enhanced products the Company
may develop, any actions by the Company's partners that may be
adverse to the Company, the success of competitive products, other
economic factors affecting the Company and its markets, and other
risks detailed from time to time in the Company's filings with the
Securities and Exchange Commission. The actual results may differ
materially from those contained in this press release. The Company
disclaims any obligation to update any statements in this press
release. DATASOURCE: AMDL, Inc. CONTACT: Gary L. Dreher, President
& CEO of AMDL, Inc., +1-714-505-4460 Web site:
http://www.amdlcorporate.com/
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