AMDL Receives Food and Drug Administration Response to Recent Submission
June 08 2005 - 11:28AM
PR Newswire (US)
AMDL Receives Food and Drug Administration Response to Recent
Submission TUSTIN, Calif., June 8 /PRNewswire-FirstCall/ -- AMDL,
Inc. (AMEX:ADL), a 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) received a non-substantial equivalence letter
from the U.S. 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(R) 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 using
DR-70(R) in conjunction with the CEA (carcinoembryonic antigen)
test, which is the standard test for this disease, there is a
significant positive gain in sensitivity of 24% for 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 test has sensitivity that varies from 40 to 70
percent, according to published literature. DOCRO is setting up a
meeting with the FDA and AMDL to discuss the FDA's specific
concerns which are necessary to grant marketing approval. 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.amdl.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. Contact: AMDL, Inc. Gary L. Dreher President & CEO
(714) 505-4460 DATASOURCE: AMDL, Inc. CONTACT: Gary L. Dreher,
President & CEO of AMDL, Inc., +1-714-505-4460 Web site:
http://www.amdl.com/
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