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. Diagnosis of influenza is difficult because the initial symptoms can be similar to other upper respiratory virus infections. More than 200,000 doctors’ offices and retail clinics can be expected to use an influenza 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.
Mesa Biotech is pursuing CLIA waiver approval from the FDA to provide a Flu A/Flu B test that meets the needs of both physician’s office practices and public health surveillance.
Clinical trial sites have been identified for an FDA 510(k) study which is now in the pre-submission stage. A pre-clinical sample collection during the 2015-2016 flu season yielded >1000 banked clinical nasal swab specimens.