AMDL, Inc. Enters Into Collaboration Agreement to Advance Development of Its AMDL DR-70 (FDP) Cancer Test
12 March 2009 - 12:30AM
PR Newswire (US)
Partnership to validate enhanced version of DR-70 cancer test
TUSTIN, Calif., March 11 /PRNewswire-FirstCall/ -- AMDL, Inc. (NYSE
Alternext US: ADL), a US-based pharmaceutical company with major
operations in China, announced today it has entered into a
collaborative agreement with Mayo Clinic to conduct a clinical
study for the validation of AMDL's next generation version of its
US FDA-approved DR-70 (FDP) cancer test. Through this validation
study, AMDL and Mayo Clinic will perform clinical diagnostic
testing to compare AMDL's DR-70 (FDP) cancer test with a newly
developed, next generation test. The primary goal of the study is
to determine whether AMDL's next generation DR-70 (FDP) test serves
as a higher-performing test to its existing predicate test and can
lead to improved accuracy in the detection of early-stage cancers.
For US FDA regulatory approval on the new test, AMDL intends to
perform an additional study to demonstrate the safety and
effectiveness of the next generation test for monitoring colorectal
cancer ("CRC"). The validation study will run for three months and
final results are expected in the second or third quarter of 2009.
"These efforts will be a significant step in validating the
efficacy of our next generation DR-70 test as a valuable tool for
the monitoring of early stage cancers," commented Dr. Andrea
Small-Howard, Vice President of Scientific Oversight, AMDL, Inc.
"Working through this critical and necessary phase in our product
development process brings us one step closer to defining a
leadership position in the cancer testing arena." Although one of
the most commonly diagnosed cancers, CRC is the third most common
cancer worldwide and the second leading cause of cancer deaths
(irrespective of gender) in the United States. There were
approximately 151,000 new cases diagnosed in the US in 2008,
roughly 51,000 deaths due to the disease*, and almost half of all
patients thought to be "cured" are expected to develop a recurrence
of CRC within 5 years -- usually due to undetected metastases.**
Frequent surveillance of diagnosed patients is recommended, but
current procedures have shortcomings. This includes the
Carcinoembryonic Antigen blood test currently used for surveillance
of CRC, which suffers from poor sensitivity and specificity (i.e.
the ability to determine if someone actually has, or does not have,
CRC). Through its study with Mayo Clinic, AMDL looks to improve
upon negatives found in existing tests. *National Cancer Institute:
Cancer Facts and Figures 2008. **Bull World Health Organ: Shike M,
Winawer SJ, Greenwald PH, et al. About AMDL: Headquartered in
Tustin, CA with operations in China, AMDL, Inc., along with its
subsidiary Jade Pharmaceutical Inc. (JPI), is a pharmaceutical
company devoted to the research, development, manufacturing, and
marketing of diagnostic, pharmaceutical, nutritional supplement,
and cosmetic products. The Company employs over 490 people in the
U.S. and China. About Mayo Clinic Mayo Validation Support Services,
an affiliate of Mayo Clinic, based in Rochester, Minnesota assists
pharmaceutical, biotechnology and diagnostic companies in
validating the clinical significance of emerging biomarkers and
technologies. Mayo's contribution of well-annotated biospecimens
and clinical follow-up data support the development of
individualized medicine, one of Mayo's strategic initiatives.
Forward Looking Statements: Safe Harbor Statement under the Private
Securities Litigation Reform Act of 1995: The statements contained
in this document include certain predictions and projections that
may be considered forward-looking statements under securities law.
These statements involve a number of important risks and
uncertainties that could cause actual results to differ materially
including, but not limited to, the performance of joint venture
partners, as well as other economic, competitive and technological
factors involving the Company's operations, markets, services,
products, and prices. With respect to AMDL Inc., except for the
historical information contained herein, the matters discussed in
this document are forward-looking statements involving risks and
uncertainties that could cause actual results to differ materially
from those in such forward- looking statements. AMDL Contact:
Kristine Szarkowitz Director-Investor Relations (Tel :)
206.310.5323 DATASOURCE: AMDL, Inc. CONTACT: Kristine Szarkowitz,
Director-Investor Relations, AMDL, Inc., +1-206-310-5323,
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