AMDL Announces ISO 13485 Audit Complete; Important Certification to Facilitate International Marketing of DR-70(R) Expected Soon
December 10 2003 - 7:08PM
PR Newswire (US)
AMDL Announces ISO 13485 Audit Complete; Important Certification to
Facilitate International Marketing of DR-70(R) Expected Soon
TUSTIN, Calif., Dec. 10 /PRNewswire-FirstCall/ -- AMDL, Inc. (Amex:
ADL; Berlin, Frankfurt), developer and marketer of tests for the
early detection of cancer and other serious diseases, today said
that it has successfully undergone an extensive audit to receive
certification for EN ISO 13485 and Canadian Medical Device
Regulations (CMDR). The Company expects to receive the certificate
in approximately two weeks. "This is significant for AMDL since ISO
13485 certification is becoming the global standard for quality
systems in the Medical Device and Diagnostic Industry," said Gary
L. Dreher, AMDL President. "Canada requires CMDR certification and
the European Union requires EN 13485 certification, while other
nations are moving to require the same certification before
allowing products to be marketed in their countries." The audit was
conducted by TUV Rhineland of North America, which performs
registration audits for ISO 13485 certification and the Canadian
Medical Device Conformity System certification. "This is an
important step forward for AMDL to ensure international sales of
our test kit and is another critical milestone in our goal to
globalize the marketing of DR-70(R)," Mr. Dreher said. 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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