Influenza affects one in five people and leads to 40,000 deaths each year in the U.S., representing both a high volume market and a high impact disease. Among children and infants globally, infection with respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections. Diagnosis of influenza and differentiation from RSV infection is difficult because the initial symptoms can be similar. More than 200,000 doctors’ offices and retail clinics can be expected to use an influenza/RSV test, a large user base representing a $1 billion dollar market for a high quality diagnostic test. The economic burden of influenza-like illness is in the range of $71-$163 billion for the U.S. alone.
The FDA, CDC, and WHO all acknowledge that existing point-of-care immunodiagnostic tests perform poorly, despite their ease-of-use. Molecular testing is recommneded instead, as influenza is a rapidly evolving virus. Because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnostics are required to direct therapy and discourage the prescription of antibiotics for these viral infections.