NEW YORK (GenomeWeb) — Alere said today that it has entered into a contract with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop diagnostic countermeasures for pandemic influenza.
Under the terms of the three-and-a-half year contract, BARDA will provide up to $12.9 million to support Alere's development of a rapid, low-cost, point-of-care flu diagnostic device with PCR-like performance. Waltham, Mass.-based Alere will be responsible for conducting clinical trials to support US Food and Drug Administration 510(k) clearance and obtaining CLIA waiver, as well as manufacturing and commercializing the resulting test.
The funding will specifically support the next generation of the Alere i Influenza A&B test, which uses the company's "Molecular in Minutes" isothermal amplification technology to provide results in less than 15 minutes. Alere launched the Alere i Infleunza A&B with CE marking in January 2014 and received FDA clearance for the diagnostic in June.
The next-generation system, Alere said, will be intended for even more widespread use outside of the traditional healthcare system without compromising the level of performance.
The project is part of BARDA's comprehensive approach to support future preparedness and medical response to a flu pandemic. The funding is subject to successful completion of various interim feasibility and development milestones, Alere said.