TUSTIN, Calif., July 8 /PRNewswire-FirstCall/ -- AMDL Inc. (NYSE Alternext US: ADL), a US-based pharmaceutical company with major operations in China, announced today the launch of a new brand name for its DR-70 (FDP) in vitro diagnostic cancer test. With today's announcement, AMDL will manufacture, market, and sell DR-70 under the more consumer-friendly, trademarked brand name Onko-Sure(TM).
Coinciding with the adoption of the new Onko-Sure(TM) brand name, AMDL also announces the successful completion of its annual ISO inspection of its Tustin, CA-based manufacturing facilities and receivership of its International Regulatory Compliance Re-certification IS0 13485:2003 for the international production of its Onko-Sure(TM) IVD cancer test.
Mr. Douglas MacLellan, Chairman and CEO of AMDL stated, "Over the past six months AMDL has been executing a very aggressive commercialization strategy for DR-70, which is progressing at a faster pace than originally expected. With several key distribution and collaboration partnerships under our belt, and more in the pipeline, we feel timing is optimal to establish a uniform and more consumer-friendly brand name for DR-70. The Onko-Sure(TM) identity represents a key milestone in AMDL's strategy for building and harmonizing an international business for this invaluable asset. We want Onko-Sure(TM) to become the undisputed #1 global brand for in vitro diagnostic cancer testing."
In the Company's view, the Onko-Sure(TM) brand offers a clearer and more concise descriptor of AMDL's IVD test, communicating it as a high quality, innovative consumer cancer test. The Company is also instilling a new tag line -- "The Power of Knowing" -- which communicates to cancer patients and their physicians the test is effective in assessing the importance of knowing whether a patient's cancer is progressing during treatment or is in remission.
AMDL's Onko-Sure(TM) in vitro diagnostic test enables physicians and their patients to effectively monitor and/or detect solid tumor cancers by measuring the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP). The product is researched, developed and manufactured in AMDL's Tustin, California-based facilities and sold to 3rd party distributors, which then sell directly to CLIA-certified reference laboratories in the US as well as clinical reference labs, hospital labs and physician-operated labs in the international market.
The test is approved by the US Food and Drug Administration (US FDA) for the monitoring of colorectal cancer and by Health and Canada as a lung cancer detection and monitoring tool. In addition the test is approved in Australia, Taiwan and Europe, where it has obtained the CE mark approval, as a general cancer screen. Throughout FY2009 AMDL continues to expand product commercialization into international markets based on other pending regulatory approvals. AMDL also plans to file for marketing approvals in other areas of the globe.
Commercialization of Onko-Sure(TM)
In 2009 the Company initiated an aggressive international commercialization plan for the Onko-Sure(TM) cancer test and has long-term plans to grow its IVD division into a multi-million dollar operation that complements its strong China-based pharmaceuticals division.
Mr. MacLellan continued, "We have achieved multiple key milestones this year that have never before been set in our IVD division. The adoption of the new Onko-Sure(TM) brand, combined with on-going program investments such that include collaboration with Mayo Clinic and the signing of various marketing, distribution and sales partnerships, reinforces the Company's commitment to growing our Tustin operations and ultimately achieving profitability."
AMDL continues its financing efforts with the goal of raising R&D expenditures on key business divisions. For additional information on AMDL, its latest business developments and portfolio of products, visit the Company's corporate website at www.amdl.com or contact Kristine Szarkowitz at firstname.lastname@example.org or 1.206.310.5323.
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 510 people in the U.S. and China.
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 email@example.com (Tel:) 206.310.5323
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