A Medical Device Daily

AMDL (Tustin, California) a U.S.-based pharmaceutical company with major operations in China, reported the launch of AMDL Diagnostics(ADI), a new wholly-owned subsidiary that will focus on the research, development, manufacture and international sales of Onko-Sure AMDL's proprietary, regulatory approved in vitro diagnostic (IVD) cancer test.

The establishment of a separate subsidiary allows AMDL to concentrate specific resources to the successful execution of that plan. ADI intends to achieve goals set forth in its 5-year plan by securing adequate financing, significantly broadening its distribution network, and continuing to research, develop, and commercialize current and future diagnostic products. ADI's management believes sales of Onko-Sure test kits are likely to exceed $100 million per year by the end of FY2014. Current projections for ADI indicate FY2009 sales of nearly $1 million and generating a small loss for the year, and sales of nearly $17 million with over $13 million in earnings in FY2010.

With the exception of heart disease, cancer causes more deaths than any other medical condition in the world. According to the World Health Organization (WHO), cancer is rapidly becoming the leading cause of death worldwide and expected to overtake heart disease by 2010. Onko-Sure has been approved by the FDA for the monitoring of colorectal cancer and by Health Canada as a lung cancer screen and cancer monitoring tool. Following the introduction of the DR-70 (FDP) cancer test in the U.S. and Canada, AMDL intends to expand product commercialization to select international markets based on other regulatory approvals and plans to file for marketing approvals in other areas of the globe.