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Devices Diagnostics FDA

 News Release - March 21, 2018

Longhorn Vaccines and Diagnostics LLC receives de novo clearance by the U.S. Food and Drug Administration for PrimeStore(R) Molecular Transport Medium establishing a new class of microbial nucleic acid stabilization devices for molecular testing

PrimeStore® MTM was designed to rapidly inactivate pathogens within the sample and stabilize the RNA and DNA to provide safer and more efficient workflow to the rapidly growing global molecular testing market

BETHESDA, Md., March 21, 2018 -- (Healthcare Sales & Marketing Network) -- Longhorn Vaccines and Diagnostics LLC (LHNVD), a private pre-analytical systems and molecular solutions company, has received a clearance from the U.S. Food and Drug Administration (FDA) for PrimeStore® Molecular Transport Medium (MTM). As the first molecular transport device designed to inactivate pathogens and stabilize both RNA and DNA for downstream molecular testing and characterization, PrimeStore® MTM provides healthcare providers, vaccine and drug developers, laboratories, and assay developers a key new component to the molecular testing process that can expand both point of care and laboratory testing without subjecting workers to live infectious agents.

FDA 510(k) clearance is a worldwide recognized standard in stringent, unbiased, and transparent regulatory review for medical devices, and is crucial to instilling confidence in new products/technologies. LHNVD has worked closely with the Center of Devices and Radiological Health (CDRH) over the last two years to define a new class of molecular transport device specific for the rapidly growing molecular testing field.

The PrimeStore® MTM de novo filing focused on specimens suspected of containing influenza A or M. tuberculosis, two of the most infectious global pathogens, and representative of RNA and DNA targets. Testing for pathogens such as influenza and M. tuberculosis, as well as their anti-microbial resistance, has been rapidly transitioning from time consuming live culture, which often requires complex biological containment facilities and can take days to weeks, to molecular testing which is significantly faster, highly sensitive, and once the sample is properly inactivated, can be done in a variety of healthcare settings. PrimeStore® MTM begins to inactivate pathogens immediately upon insertion into the device allowing the sample to be tested within minutes of collection or shipped at ambient temperature to a testing facility anywhere in the world.

"PrimeStore® MTM and its unique characteristics can accelerate efforts to identify and control seasonal, endemic, and pandemic diseases such as influenza and M. tuberculosis, opening up timely, accurate testing to billions of people in the United States and around the World," states Gerald W. Fischer, MD, Pediatric Infectious Disease Specialist and CEO of LHNVD. "To truly impact highly infectious and rapidly evolving pathogens, utilizing point of care, hospital-based, and centralized high throughput laboratory testing will be necessary."

Seasonal influenza in 2017-2018 has globally seen high rates of infection, hospitalization and mortality.
   Potential pandemic strains such a H5N1 and H7N9 continue to cause disease and significant mortality in small clusters. During the 2009-2010 H1N1 pandemic it was estimated that over 60 million people were infected in the US, and globally up to half a million people died from the virus. According to the US Centers for Disease Control and Prevention (CDC), "Because colds and flu share many symptoms, it can be difficult (or even impossible) to tell the difference between them based on symptoms alone. Special tests that usually must be done within the first few days of illness can tell if a person has the flu." Current medications, and those in late stage testing, are most effective when taken early in the course of infection. Products such as PrimeStore® MTM that can expand testing access points and improve testing efficiency, should greatly impact Governments' response and improve health outcomes in both seasonal and pandemic influenza outbreaks.

LHNVD plans to seek expanded labeling for additional sample types to include multiple respiratory samples, blood, fecal, urine, tissue, and dry skin swabs (STI testing), all of which have been successfully inactivated and the nucleic acid preserved in PrimeStore® MTM in research studies conducted around the world. Additional pathogens and non-communicable disease samples will also be included to maximize the global role PrimeStore® MTM can play in expanding molecular testing.

About PrimeStore MTM

PrimeStore® MTM is FDA cleared and intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore® MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.

Peer reviewed journal articles, abstracts, posters, and vaccine development clinical trials have demonstrated PrimeStore® MTM's ability to generate highly sensitive results with multiple pathogens and sample types on several Real-Time PCR platforms to include Roche's LightCycler and Thermo Fisher's ABI 7500, as well as next generation sequencers including Thermo Fisher's Ion Torrent and Illumina's MiSeq. PrimeStore® MTM has been demonstrated to be compatible with manual and high-throughput extractions systems from LHNVD, Qiagen, Thermo Fisher, bioMeriuex, and Roche. Published studies have shown it to be compatible with Cepheid's GeneXpert MTB/RIF test.

LHNVD has received over 25 issued patents Worldwide (including the US, EU, China, India, South Africa, Canada and Australia) for the composition and use of PrimeStore® MTM.

About LHNVD

Longhorn Vaccines and Diagnostics is a veteran owned, closely held Limited Liability Company headquartered in Bethesda, MD with laboratories in San Antonio, TX and Gaithersburg, MD.


Source: Longhorn Vaccines and Diagnostics

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