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.
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-
AMDL Contact: Kristine Szarkowitz Director-Investor Relations firstname.lastname@example.org (Tel :) 206.310.5323
|SOURCE AMDL, Inc.|
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