AMDL Inc. (NYSE Alternext US: ADL), a US-based pharmaceutical company with major operations in China, announced the inauguration of AMDL Diagnostics Inc. (ADI), a new wholly-owned subsidiary that will focus on the research, development, manufacture and international sales of Onko-Sure(TM)-- AMDL's proprietary, regulatory approved in vitro diagnostic (IVD) cancer test.
Since the start of FY2009, AMDL has made significant progress in commercializing Onko-Sure(TM) for both the domestic and international markets, achieving planned milestones that include:
- Increased market awareness both domestically and internationally;
- Expanded product availability through signed distribution agreements with partners in the US, Canada, Asia and India;
- Preparation for the future through a signed collaboration agreement with Mayo Clinic for development of the next-generation version of Onko-Sure test; and,
- Engagement with industry experts, scientists, physicians and business development consultants in the scientific and medical communities to assist in furthering ADI's commercializing efforts.
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(TM) test kits are likely to exceed US$100 million per year by the end of FY2014. Current projections for ADI indicate FY2009 sales of approximately $1 million and generating a small loss for the year, and sales of approximately $17 million with over $13 million in earnings in FY2010.
"Today's announcement underscores our commitment and focus on building AMDL for the future," stated Mr. Douglas MacLellan, Chairman and CEO of AMDL Inc. "To date, our China operations have overshadowed the consequential revenue opportunity of Onko-Sure(TM) -- 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."
ADI will be run by Mr. Douglas MacLellan who continued, "Many exciting opportunities exist for ADI and its investors. Onko-Sure(TM) can detect and/or monitor for 14 different types of cancer, including lung, stomach, colorectal, liver, and breast cancer which according to the World Health Organization, causes the most cancer deaths every year. Our intention is to take Onko-Sure(TM) and ADI to a level our shareholders have never experienced before."
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(TM) has been approved by the US 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 US 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.
ADI's 5-year business strategy and plan outlines the Company's mission and vision, executive management team, 5-year financial growth targets, international distribution strategy, and future product development plans. Highlights include: