Longhorn’s PrimeStore
MTM is the Only FDA Cleared Nucleic Transport Device that Inactivates Microbes
Within the Device Allowing for Safe Transport and Testing
BETHESDA, Md.---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.
Renee Volpini
Media Specialist
917-923-8117