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 viruses, bacteria and 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:

  1. Infectious, unprocessed nasal washes suspected of containing influenza A virus RNA

  2. Infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples

The device can be used for molecular testing and sequencing of blood, plasma, respiratory samples, urine, tissues and stool in human, animal, avian, plant and environmental forensics.

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, including gram-positive/negative bacteria and viruses, and preserves/stabilizes “naked” 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.

Research

Effective in inactivating numerous virus types.

Multiple studies have shown that PrimeStore MTM rapidly inactivates infectious pathogens.

  • SARS-CoV-2

  • Influenza (High/low path)

  • Adenovirus

  • Monkeypox

  • Foot and Mouth Disease

  • African Swine fever

  • Blue Tongue

  • Bacteria (E. coli, MRSA, and P. aeruginosa)

  • Fungi (C. albicans, A. niger)

  • MTB/Mbovis

  • New Castle Disease

  • Parasites (Cryptosporidium*)

    *No bead beating or heating required

Ideal for testing large populations.

SARS-CoV-2 Study shows PrimeStore MTM is ideal for testing large populations such as employees and students by providing a significant reduction in infrastructure and cost. Pooling samples require small amounts of each sample to be combined into a new tube. PrimeStore MTM allows the process to occur on the bench top. In contrast, samples in VTM/Saline are still considered infectious and must be transferred in a biological safety cabinet, significantly slowing down the workflow.

Temperate stability during shipping and handling.

In one independent study, PrimeStore MTM showed stability for a 117-day average from sample collection to extraction with no cold chain necessary.