A Medical Device Daily

AMDL (Tustin, California), a pharmaceutical company with major operations in China, reported the formation 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 in vitro diagnostic (IVD) cancer test.

Since the start of FY2009, AMDL said it has made significant progress in commercializing Onko-Sure for both the domestic and international markets.

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 about $1 million and generating a small loss for the year, and sales of about $17 million with more than $13 million in earnings in FY2010.

"To date, our China operations have overshadowed the consequential revenue opportunity of Onko-Sure a potentially life-saving IVD test for literally millions of cancer patients worldwide. By establishing a separate subsidiary with specific resources dedicated to the division we believe we are in a tremendously stronger position to capitalize on the cancer IVD market," said Douglas MacLellan, chairman/CEO of AMDL. ADI will be run by MacLellan.

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.