Longhorn Vaccines and Diagnostics has been granted Emergency Use Authorization (EUA) from the 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.
Longhorn Vaccines and Diagnostics expects to continue the development of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay and expects to submit a separate 510(k) in 2010.
Gerald Fischer, chief executive officer of Longhorn Vaccines & Diagnostics, said: “Sample integrity, and the ease and economy of transporting collected samples are key components to testing during outbreaks. 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.”
Scott Altman, international health expert, assistant professor of clinical emergency medicine at the Northwestern University Feinberg School of Medicine, said: “Influenza-like-illness puts a significant strain on Emergency Departments during the standard Influenza season. The atypical epidemiology of H1N1-09 has magnified the impact on healthcare systems around the world.
“The principal morbidity and mortality of H1N1-09 was in young, previously healthy patients who accessed the system in large numbers. We were quite fortunate this time around that it came early, during relatively mild weather. Having access to reliable, rapid testing will significantly improve the quality and timeliness of care we can provide in both hospital/ED, and community health settings.”