The U.S. Food and Drug Administration (FDA) granted the first waiver to allow a nucleic acid-based test -- the Alere i Influenza A&B test -- to be used in general health care settings on Tuesday.
“Today’s decision allows the first nucleic acid-based test to be available in clinical settings that previously could not use this technology,” Alberto Gutierrez, of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health Director, said. “We expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future. Once cleared by FDA, such tests can allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions.”
Nucleic acid-based tests previously could only be used in certain labs.
Because the FDA granted a waiver under the Clinical Laboratory Improvement Amendments, the Alere i Influenza A & B test can now be distributed to sites that include physicians’ offices, emergency rooms and health department clinics.
The Alere i Influenza A & B test uses nasal swab samples from patients who may have the flu with results available in as little as 15 minutes. Negative results do not discount the influenza virus infection, but the test is designed to help in diagnosing and evaluating other risk factors.