Navigation Links
Longhorn Vaccines & Diagnostics LLC Receives FDA Emergency Use Authorization (EUA) for the First 2009 H1N1 Influenza Assay to Include a Molecular Transport Medium (MTM)

SAN ANTONIO, Feb. 22 /PRNewswire/ -- 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."

2009 H1N1 is a new influenza virus that was detected in the United States in April 2009. As such, children and younger adults are less likely than older people to have immunity to this virus, and illness may be more severe and widespread as a result (1). In June 2009, the World Health Organization (WHO) announced that the spread of the novel 2009 H1N1 virus had reached pandemic phase 6, the highest level of pandemic alert designated by the organization (2).

"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," stated international health expert, R. Scott Altman MD, MPH, MBA, FACEP, Assistant Professor of Clinical Emergency Medicine at the Northwestern University Feinberg School of Medicine.

Longhorn Vaccines and Diagnostics will continue the development of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ and expects to submit a separate 510(k) in 2010.

About the FDA's Emergency Use Authorization

The US Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA has issued emergency use authorizations to make diagnostic and therapeutic tools available to public health and medical personnel for use in the diagnosis of 2009 H1N1 influenza virus under certain circumstances.

The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved and uncleared medical products following a determination and declaration of emergency, provided certain criteria are met. The FDA can only grant emergency use authorization for the duration of the emergency, which is currently set to expire on April 26, 2010, unless it is terminated sooner or renewed. The FDA may also revoke an EUA prior to the termination of the emergency.

About Longhorn Vaccines & Diagnostics

Longhorn Vaccines & Diagnostics is a private a biotech company located in San Antonio, TX that develops, and commercializes platform neutral RRT-PCR assays and develops vaccines for infectious diseases.

While initially focused on influenza diagnostics, Longhorn Vaccines & Diagnostics is working to develop PrimeMix assays for malaria, tuberculosis, dengue, and adenovirus. The company's proprietary molecular transport medium allows researchers to collect specimens from around the world and safely ship them to laboratories without expensive and cumbersome cold chain packaging including dry ice.  The PrimeStore MTM will facilitate standard sequencing and meta-genomic analysis of samples by improving the quality of the microbial nucleic acids in the collected specimens when they finally arrive in the laboratory.  

Longhorn Vaccines & Diagnostics is developing a proprietary universal influenza vaccine.  This vaccine is designed to provide broad protection against influenza viruses.  Its unique properties may make it easier, quicker, and less expensive to manufacture compared with standard influenza vaccines


(1) CDC: Facts About Novel H1N1 Influenza; May 2009


SOURCE Longhorn Vaccines & Diagnostics

Back to top



SOURCE Longhorn Vaccines & Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. New method makes vaccines stable at tropical temperatures
2. Corgenix and Tulane Announce Award of Additional NIH Contract to Expand Lassa Fever Research Towards Development of Vaccines and Improved Therapeutic Agents
3. BARDA Announces Modification to Development Approach for Recombinant Protective Antigen Anthrax Vaccines
4. Biological H1N1 Vaccines: Too Little, Too Late
5. Reportlinker Adds Cancer Vaccines: Measuring Market Potential
6. New Non-Biological Synthetic Replikins(TM) Vaccines Shown to Be Effective and Fast; WorldVaccines(TM), Ltd Formed for Testing and Distribution
7. ImmunoVaccine Technologies Signs Agreement with National Institutes of Health to Explore Vaccines for HIV and Malaria
8. Novavax and Vivalis Sign a Research License Agreement to Use the EB66(R) Cell Line for the Production of Virus Like Particle Based Vaccines
9. IDRI Collaborates with the Brazilian Butantan Institute To Develop Novel Vaccines Against Leishmaniasis
10. China Bio-Immunity Corporation Initiates Voluntary Recalls of Rabies Vaccines
11. Cleveland Clinic Recognizes New Strategies for Creating Vaccines for Avian Flu as a Top Ten Medical Innovation for 2009
Post Your Comments:
(Date:12/1/2015)... 1, 2015  Symic, a clinical-stage biotherapeutics company developing ... (ECM), today announced that it has secured $25 million ... pipeline, including its lead candidates SB-030 and SB-061. The ... participation by all existing major investors, as well as ... capital raised by Symic to over $43 million since ...
(Date:12/1/2015)... Dallas, Texas (PRWEB) , ... December 01, 2015 ... ... its annual global meeting this month and Dr. J. Kyle Mathews ... worldwide.” This includes the new single site hysterectomy. , An experienced urogynecologist, founder ...
(Date:11/30/2015)... ... 2015 , ... Global Stem Cells Group Chile ... Central America and abroad for the first Iberoamerican Convention on Aesthetic Medicine, Cosmetology ... Testart will present and discuss new trends in anti-aging stem cell treatments, regenerative ...
(Date:11/30/2015)... ... ... Global Stem Cells Group announced the opening of a new core patient care ... in northern Chile. The facilities are part of GSCG’s expansion efforts in Latin America. ... stem cell medicine to patients from around the world. , The clinics will be headed ...
Breaking Biology Technology:
(Date:11/2/2015)... MENLO PARK, Calif. , Nov. 2, 2015 /PRNewswire/ ... to $9 million to provide preclinical development services to ... Under the contract, SRI will provide scientific expertise, modern ... a wide variety of preclinical pharmacology and toxicology studies ... --> --> The PREVENT Cancer Drug ...
(Date:10/29/2015)... LA JOLLA, Calif. , Oct. 29, 2015 /PRNewswire-USNewswire/ ... released a new report titled, "DNA Synthesis and Biosecurity: ... how well the Department of Health and Human Services ... was issued in 2010. --> ... advances, but it also has the potential to pose ...
(Date:10/29/2015)... , Oct. 29, 2015  Rubicon Genomics, ... for U.S. distribution of its DNA library preparation ... and Rubicon,s new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq ... the preparation of NGS libraries for liquid biopsies--the ... diagnostic and prognostic applications in cancer and other ...
Breaking Biology News(10 mins):