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FDA Grants First CLIA Waiver for Molecular Flu Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration said on Tuesday that it has granted the first CLIA waiver to a nucleic acid-based flu diagnostic test, the Alere i Influenza A&B, allowing it to be used in a wider variety of healthcare settings.

Alere's test had previously been available for use only in certain laboratories. With the CLIA waiver, it can be distributed to non-traditional laboratory sites, including doctors' offices, emergency rooms, health department clinics, and other healthcare facilities, the FDA said.

The test uses a nasal swab from a patient showing signs and symptoms of the flu and provides results in as little as 15 minutes. Negative results do not rule out a patient may have the flu, FDA said, adding the test is intended as a diagnostic aid, along with the evaluation of other risk factors.

FDA initially cleared the Alere i Influenza A&B test last June for detecting influenza A and B viral RNA in nasal swab samples. The test was originally categorized as moderate complexity.

While it is the first nucleic acid-based test to be made available in clinical settings that previously could not use the technology, "we expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiologic Health in the FDA's Center for Devices and Radiological Health.