BETHESDA, Md.--(BUSINESS WIRE)--Longhorn Vaccines & Diagnostics, an innovative molecular tool, assay and vaccine development company focused on serving unmet critical needs in both developed and developing nations, announced today that the U.S. Food and Drug Administration (FDA) has recommended that the company collaborate with diagnostic assay manufacturers to ensure that Longhorn’s PrimeStore MTM® is included as a transport device in Emergency Use Authorization (EUA) applications submitted to the FDA for research samples for the Coronavirus disease 2019 (COVID-19). The suggestion comes in conjunction with key actions to advance development of novel Coronavirus medical countermeasures outlined by the FDA’s US Center for Devices and Radiological Health.
“In the wake of the COVID-19 outbreak, U.S. diagnostic manufacturers are developing and submitting to FDA EUA applications for nucleic acid based tests for COVID-19 using sample collection devices such as viral transport mediums that keep the virus alive within the sample requiring refrigeration and containment,” said Jeff Fischer, President of Longhorn. “Unlike standard methods for collecting and transporting samples, PrimeStore MTM safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory based molecular testing and characterization with no need for special containment facilities.”
Currently, COVID-19 assays approved for EUA with viral transport medium must be run in Biosafety level (BSL) 3 or 4 laboratories or inactivated under containment conditions. “There are simply not enough of these facilities to meet the medical and scientific community’s demands for up-to-the-minute results,” explained Fischer. “Deactivating samples will allow for testing to be conducted in many more labs, including BSL-1 and BSL-2 facilities.”
The US FDA Center for Devices and Radiological Health initiated communication with Longhorn to suggest that the company reach out to diagnostic assay manufacturers to include PrimeStore MTM in their EUA applications. If a manufacturer has already submitted an application, it can provide a supplement with PrimeStore MTM to allow those assays to be used in CLIA (Clinical Laboratory Improvement Amendments 1988) labs around the country. Supplements to EUA applications already approved will receive priority review and will not require standard Commissioner level approval.
“As we saw in Wuhan during the first month of the outbreak, there is a bottleneck in many laboratories that are not equipped to handle samples of COVID-19. Delays in testing cause samples to degrade and high quality assays to generate false negative results, leading to further virus spread and wasting resources,” stated Luke Daum, Ph.D., Chief Scientific Officer and Executive Vice President of Longhorn. “We are pleased to be seen as part of the solution and look forward to partnering with companies in the United States and globally, to ensure safe, top quality scientific research is advanced as we combat the coronavirus pandemic.”
The Biomedical Advanced Research and Development Authority (BARDA) and the COVID-19 MCM Task Force are reviewing an application to add PrimeStore MTM to stockpile for COVID-19 response and future outbreaks and pandemics that would create similar laboratory challenges. Outbreaks and pandemics could include animal diseases such as African swine fever, classical swine fever, and foot and mouth disease, which the U.S. Department of Agriculture Foreign Animal Disease Diagnostic Laboratory have already tested in PrimeStore MTM.
PrimeStore MTM was first authorized in 2009 by the FDA as a component of a complete molecular diagnostic kit, as part of the agency’s H1N1-09 Influenza Pandemic Emergency Use Authorization.
About PrimeStore MTM
PrimeStore MTM (Molecule Transport Medium) is the first and only microbial nucleic acid storage and transport device cleared by the US Food and Drug Administration (US FDA). It is indicated to rapidly inactivate viruses (including Influenza), bacteria (including Mycobacterium tuberculosis) and high consequence veterinary pathogens (including ASFv, CSFv, FMDv, HPAI, NDv) within the sample and stabilize the RNA and DNA to provide safer and more efficient workflow for molecular testing and sequencing.
PrimeStore MTM alleviates the challenge of collecting a quality sample and transporting it in a safe and timely manner to any laboratory that can effectively test that sample using modern molecular platforms. Researchers worldwide have used the device successfully, including in remote regions of Nepal, India, China, South Africa, Peru, Pakistan, Papua New Guinea, and Ukraine, as well as densely populated cities such as Mumbai, Pretoria, Macau and Singapore.
PrimeStore MTM has multiple issued patents in the United States and worldwide.
About Longhorn Vaccines and Diagnostics
Longhorn Vaccines & Diagnostics is an innovative molecular tool, assay and vaccine development company focused on serving unmet critical needs in both developed and developing nations. Longhorn’s core product, PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA approved, state-of-the-art ambient temperature molecular diagnostic collection and transport device that can help governments, global health organizations and drug manufacturers improve the diagnosis and treatment of infectious diseases such as mycobacterium tuberculosis (TB) and Influenza. Unlike standard devices for collecting and transporting TB samples, PrimeStore® MTM is the first molecular transport device that can safely deactivate pathogens and stabilize RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory based molecular testing and characterization. Longhorn is based in Bethesda, Maryland.
