HHS Boosts Early Influenza Detection With $21M in Awards

With the arrival of the 2014 flu season comes news that the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) granted two awards in contracts for the development of improved, cost-effective influenza testing. The tests will advance diagnostic capabilities in doctors’ offices, clinics, and hospitals with quick and accurate flu diagnoses. The contracted companies received a combined award total of approximately $21 million. The tests use different technologies to detect influenza viruses and offer different levels of information about the viruses detected.

The first award is centered on a low-cost molecular test under a 3.5-year, $12.9 million contract with Alere Inc., located in Waltham, Massachusetts. The company plans to develop the Alere™ i Influenza A & B test, which could yield results within 15 minutes and detect which type of flu virus a patient has. The Influenza A & B Test is a rapid, instrument-based, molecular diagnostic test that uses isothermal nucleic acid amplification technology for detecting and differentiating influenza A and B through nasal swabs of symptomatic patients. Alere will conduct the required clinical studies and submit the results to the FDA for approval, including a Clinical Laboratory Improvement Amendments waiver, which would allow the rapid molecular test to be performed in doctors’ offices and hospitals.

The second award went to InDevR Inc., located in Boulder, Colorado. The funding allows the progression of a biochip test under a two-year, $7.9 million contract with options to extend the contract up to $14.7 million over four years. InDEvR’s FluChip-8G™ test will identify seasonal flu viruses and novel flu viruses within four hours by using a multiplexed analysis of eight genes. The test will be used in doctor’s offices and hospitals. Presently, this type of genetic testing is conducted only in state, federal, or specialty laboratories, and results take days rather than hours. InDevR maintains that if the test proves successful during the first two years, it will conduct required clinical studies for submission approval from the FDA and subsequently will develop a fully automated version of the test. This test will also use nasal swabbing.

The director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), Robin Robinson, Ph.D., said, “Administering fast and inexpensive tests at the point of care has tangible benefits to personal and public health, particularly in helping doctors prescribe the right therapy immediately.” Robinson’s office will be responsible for overseeing the test development programs.

BARDA supports development of other flu diagnostic platforms, including a test to identify drug resistance in influenza and other vaccine technologies. It also welcomes additional proposals for advanced development of new drugs and products to diagnose and treat other illnesses.