AMDL Inc 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 brand name Onko-Sure™.

Coinciding with the adoption of the new Onko-Sure 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 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 identity represents a key milestone in AMDL’s strategy for building and harmonizing an international business for this invaluable asset. We want Onko-Sure to become the undisputed #1 global brand for in vitro diagnostic cancer testing."

In the Company’s view, the Onko-Sure 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.

Source: AMDL Inc