AMDL To Meet With U.S. Food and Drug Administration in Response to the Recent Adjunctive Submission
June 15 2005 - 6:00AM
PR Newswire (US)
AMDL To Meet With U.S. Food and Drug Administration in Response to
the Recent Adjunctive Submission TUSTIN, Calif., June 15
/PRNewswire-FirstCall/ -- AMDL, Inc. (AMEX:ADL), a developer and
marketer of tests for the early detection of cancer and other
serious diseases, recently 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 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. DOCRO
has sent a response and set up a meeting on Thursday, June 16, 2005
with the FDA and AMDL to discuss the FDA's specific concerns, which
must be favorably resolved to advance the regulatory process. The
adjunctive submission showed that by using DR-70(R) in conjunction
with the CEA test, which is the standard test for this disease,
there is a significant gain in positive concordance 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 by itself has
sensitivity that varies from 40 to 70 percent, according to
published literature. 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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