Potential tests to help doctors diagnose influenza sooner and more accurately will advance in development under contracts from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA).
The tests could help boost influenza pandemic preparedness by increasing diagnostic capabilities in near-patient care settings such as doctors’ offices, clinics, and hospitals.
One award will advance the development of a simple, low-cost molecular test under a 3.5-year, $12.9 million contract with Alere Inc., headquartered in Waltham, Massachusetts.
The other award, to InDevR Inc., of Boulder, Colorado, will allow a biochip test to move forward under a two-year, $7.9 million contract with options to extend the contract up to $14.7 million over four years.
The tests use different technologies to detect influenza viruses and offer different levels of information about the viruses detected. Both tests would use swabs taken from a patient’s nasal passage.
Alere will use the funding to develop the next generation of its current Alere™ i Influenza A & B test, which was launched in January 2014 in Europe and received clearance from the U.S. Food and Drug Administration (FDA) in June 2014. The test can yield results within 15 minutes and show whether a patient has an infection caused by a seasonal influenza virus type A or B infection.
InDevR will develop its FluChip-8G test to identify seasonal influenza viruses and recognize novel flu viruses within four hours in near-patient settings. Currently, this type of detailed genetic testing is conducted in state, federal, or specialty laboratories, and can take days to complete. If successful during the first two years, InDevR will conduct clinical studies necessary to submit for clearance or approval from the FDA and will develop a fully automated version of the test.
“The FluChip-BG system will provide an unprecedented level of information about viruses detected in Human clinical specimens, without the need for virus isolation. This information will allow physicians to make better informed decisions about treatment options for their patients,” said Dr. Kathy Rowlen, InDevR’s CEO.
“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,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA) whose office will oversee the development programs. “Prescribing medication or other therapies in a more targeted way is good stewardship and will be critical to reducing the risk of antimicrobial resistance.”
Distinguishing viral influenza infections from bacterial infections could aid doctors and patients in choosing the best treatment, and could reduce unnecessary antibiotic use, as antibiotics are ineffective in treating illness caused by viruses. In addition, testing for influenza viruses in doctors’ offices, clinics, and hospitals could improve use of precautions among patients and health care workers to reduce spread of influenza from person to person.
Improved tests available in more settings can alert doctors and public health authorities to community outbreaks of respiratory illness and signal new viruses causing illness. A new influenza virus to which people do not have immunity could potentially spread quickly and have pandemic potential.
Sources: HHS, Alere, and InDevR press releases, adapted.
