Longhorn Vaccines & Diagnostics today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ in CLIA high complexity laboratories. . The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ is a ready-use assay that requires no mixing prior to use and has been authorized for use on the ABI 7500. The device includes PrimeStore MTM, a clinical collection and transport solution that preserves the released nucleic acids, including labile RNA for testing and contains an internal positive control, providing the first specimen collection solution to contain an internal RNA control capable of tracking the degradation of the sample from the point of collection.
"Sample integrity, and the ease and economy of transporting collected samples are key components to testing during outbreaks," said Gerald Fischer, MD, Longhorn Vaccines & Diagnostics' Chief Executive Officer. "An infectious disease physician and a molecular biologist designed The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ to generate rapid, high quality PCR results, in as little as two hours while improving safety, and reducing laboratory preparation time."