Alere Inc (NYSE:ALR) and The U.S. Department of Health and Human Services has signed up a contract for the development of diagnostic countermeasures for pandemic influenza. BARDA will provide fund of up to $12.9 million for the development project, subject to completion of various terms defined in the agreement. It is a 3.5 year contract under which Alere will provide its contributions in preparing the advanced measures to tackle an influenza pandemic. The objective is to develop molecular, rapid and low-cost influenza diagnostic equipment. Alere will conduct clinical trials to get the FDA 510(K) clearance, as well as CLIA waiver. It will also manufacture and commercialize the diagnostic device.
For the research purpose, the most important thing required is funds, and Alere has it which will be utilized for the development of the next generation of its existing product Alere™ i Influenza A & B test. The testing will provide highly accurate, molecular results in just 15 minutes. The testing begun in Europe in January 2014, however, received the U.S. FDA approval in June 2014. The new product will be used outside the existing traditional healthcare system. However, it will not compromise in any way on parameter of clinical performance.
Alere Inc (NYSE:ALR) molecular technology provides several benefits, and it is now validated more after the BARDA contract. Alere will work in association with BARDA to develop the next-generation testing product that can provide accurate results at a lower cost. The next-generation i Influenza test will be more accessible for use in all conditions. BARDA wants to adopt a comprehensive approach in preparing medical countermeasures for an influenza pandemic, and the development of next-generation product is a part of the same approach. The overall program of BARDA includes development of therapeutics, diagnostics and vaccines as countermeasures for influenza preparedness. It intends to encourage the building and sustaining measures for the domestic manufacturing.