FDA De Novo Clearance
The original FDA-cleared inactivation media.
History
Inspired by the threat of a worldwide pandemic.
PrimeStore® Molecular Transport Medium (MTM) was invented in 2007 – a time when the H5N1 influenza was expected to spread globally. Our efforts were rooted in the understanding that to truly impact highly infectious and rapidly evolving pathogens such as H5N1, the use of point of care, hospital-based, and centralized high throughput laboratory testing is absolutely necessary. However, testing in this capacity has the potential to put lab workers at a high risk of exposure.
We created PrimeStore MTM as a transport device that could protect lab workers by rapidly inactivating pathogens within a sample.
Beginning in 2016, we worked alongside the FDA to establish a new category of class II devices: The Microbial Nucleic Acid Stabilization and Transport Device. All inactivating transport devices must be cleared by the FDA and compare themselves to PrimeStore MTM.
Uses
PrimeStore MTM stabilizes, transports and inactivates:
Infectious, unprocessed nasal washes suspected of containing influenza A virus RNA
Infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples
The cold chain is not needed for transportation from collection to the laboratory. The MTM media disrupts/lyses lipid membranes, destroys proteins and enzymes, inactivates nucleases and proteases, inactivates infectious biological pathogens, MTB and Influenza A claimed, and preserves/stabilizes RNA/DNA at elevated temperatures.
The USDA recently expanded its use of PrimeStore MTM beyond SARS-CoV-2 and African Swine Fever to facilitate the tracking and surveillance of the avian influenza strain that is infecting wild bird populations and US poultry flocks.
