PrimeStore® Molecular Transport Medium (MTM) is the first molecular transport device designed to inactivate pathogens and stabilize both RNA and DNA for downstream molecular testing and characterization. Its ability to transport RNA and DNA at ambient temperature saves significant cost and infrastructure associated with eliminating the cold chain. It has been specifically validated for coronavirus screening with multiple published peer reviewed studies.
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. To truly impact highly infectious and rapidly evolving pathogens, utilizing point of care, hospital-based, and centralized high throughput laboratory testing will be necessary.
For Clients that need high quality molecular material, but need to culture, test for antibodies, or analyze specimen components that PrimeStore MTM destroys, LHNVD has developed two sample collection medias optimized for molecular testing while maintaining sample viability and proteins. Please contact LHNVD for additional information.