AMDL Retains Well Known Regulatory Affairs Firm to Assist in Seeking DR-70(R) Clearance to Market
September 13 2006 - 6:00AM
PR Newswire (US)
TUSTIN, Calif., Sept. 13 /PRNewswire-FirstCall/ -- AMDL, Inc.
(AMEX:ADL), developer and marketer of tests for the early detection
of cancer and other serious diseases, announced today that it has
retained the statistical and regulatory consulting firm R. P.
Chiacchierini & Associates, LLC, Rockville, Maryland,
(http://www.rpcaconsulting.com/) to provide additional statistical
analysis for the U.S. Food and Drug Administration (FDA) to support
the Company's request for clearance to market its DR-70(R) cancer
test kit in the U.S. R.P. Chiacchierini & Associates are
experienced in all aspects of statistical consulting and regulatory
affairs for device and biologic products. The Company, which has
assisted more than 700 firms with their filings, employs former FDA
senior management, policy makers, reviewers and other industry
personnel. Dr. Chiacchierini, President and CEO, served in various
management positions with the FDA and is co-author of a number of
agency guidance documents. He served as Chief Scientific Officer in
the U.S. Public Health Service under Surgeon General C. Everett
Koop. "We are confident that R.P. Chiacchierini will provide the
additional statistical analysis necessary for gaining clearance to
market DR-70(R) from the FDA," said Gary Dreher, AMDL CEO. "The
Company's primary objective remains receiving approval to market
its DR-70(R) cancer test kit in the U.S., which will assist the
Company's effort to market internationally." 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 14 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 This news release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements
are subject to certain risks and uncertainties, and actual
circumstances, events or results may differ materially from those
projected in such forward-looking statements. The Company cautions
readers not to place undue reliance on any forward-looking
statements. The Company does not undertake, and specifically
disclaims any obligation, to update or revise such statements to
reflect new circumstances or unanticipated events as they occur.
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.rpcaconsulting.com/ Web site: http://www.amdl.com/
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