NEW YORK (GenomeWeb News) – Genetic test developer DxNA said today that the US Food and Drug Administration has granted Emergency Use Authorization (EUA) for the firm's PCR-based test for 2009 H1N1 influenza.
The EUA for DxNA's GeneSTAT detection platform is a legal means that allows FDA to authorize new medical devices during medical emergencies.
The St. George, Utah-based company said that it initially developed the test, which is portable and weighs less than 10 pounds, to identify the H5 avian flu and submitted it for evaluation as a diagnostic for 2009 H1N1 swine flu early this year.
"This new diagnostic test has the potential to significantly reduce the impact of 2009 H1N1 influenza by allowing for testing under appropriate laboratory conditions achievable even in a local hospital setting," DxNA President and CEO Phillip Grimm said in a statement
The company also is developing diagnostic tests for malaria, tuberculosis, human papilloma virus, Group B strep, and other diseases.