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HHS to Fund Development of Diagnostics for Health Emergency Threats

NEW YORK (GenomeWeb) – The US Department of Health and Human Services announced this week its intention to fund research and development projects related to the development of molecular diagnostics that can help protect the US population against key health emergency threats.

According to the HHS, the funding is being made available as part of an ongoing effort by its Office of the Biomedical Advanced Research and Development Authority (BARDA) to support the development of countermeasures against pandemic influenza and emerging respiratory infectious diseases, as well as biological, radiological, and nuclear (BRN) agents.

For pandemic flu, the 2009 H1N1 outbreak demonstrated the unpredictability and rapidity with which a novel influenza strain can impact the world's population, the HHS said. "The ever-present and ever-evolving threat of novel influenza subtypes … H7N9 highlights the need to continue optimizing available medical countermeasures and developing entirely new modalities for prevention and treatment of influenza disease."

As such, the agency is seeking grant applications for research and development projects focused on test systems and diagnostics for influenza and other emerging respiratory infectious diseases. The HHS is specifically seeking next-generation sequencing-based methods and tools that can quickly identify seasonal and novel influenza viruses and diagnose infections in CLIA laboratories. It is also looking for diagnostics that can identify antiviral drug-resistant flu viruses, as well as ones that can be used at home or in a point-of-care setting.

As part of BARDA's preparedness mission, the HHS is also supporting research around diagnostics appropriate for use following BRN exposure. These include self-assessment tools enabling individuals who have been exposed to ionizing radiation; and point-of-care assays, preferably ones that work on existing platforms, for determining absorbed doses of ionizing radiation.

The HHS is also interested in bio-threat agent diagnostics such as anthrax infection assays that are either portable and designed for use by non-professionals, as well as high-throughput systems that are optimized for use with widely used instrument platforms.

Also eligible for HHS funding are studies characterizing pathogen or disease-specific biomarkers with diagnostic potential, in addition to studies examining the effectiveness of diagnostic assays in special populations including immunocompromised, pregnant, or diabetic individuals. 

The agency is also specifically seeking to support the development of diagnostics that can identify drug resistance in priority bacterial pathogens such as C. difficile, carbapenem-resistant Enterobacteriaceae, and multi-drug-resistant Acinetobacter.

Of particular interest to the HHS are tests that can be used rapidly in point-of-care settings, multiplex molecular assays for use in moderate- and high-complexity labs, tests enabling antibiotic clinical trials, and novel phenotypic platforms and assays that can accurately identify pathogen resistance or susceptibility to treatment.

As part of these funding opportunities, the HHS also intends to fund vaccine and therapeutic development for both pandemic influenza and BRN exposure.  The agency noted that specific levels of funding for approved projects have not been set and will be dependent on congressional appropriations.

Additional details about the funding can be found here and here

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