World TB Day 2018: US Food and Drug Administration Clears PrimeStore® MTM

PrimeStore® MTM is an Important New Device in the Worldwide Fight Against Mycobacterium Tuberculosis.

Longhorn Vaccines and Diagnostics LLC (LHNVD), a private pre-analytical systems and molecular solutions company, has spent the last six years validating PrimeStore^® MTM for inactivation of M. tuberculosis (TB) and stabilization of the DNA to facilitate point of care and centralized molecular detection of TB. In addition, high quality DNA in the original sample is preserved in PrimeStore^® MTM allowing further drug sensitivity testing by line probe assays or next-generation sequencing.  After two years of thoughtful discussions and careful review, the US Food and Drug Administration (FDA), through its de novo process, cleared PrimeStore^® MTM as a new class of medical device.

"We are excited to announce the FDA clearance of PrimeStore^® MTM, a paradigm shift in biological sample transport technology. Leaders of the TB community are driving the rapid phase out of centuries old diagnostic methods, and fully embracing current and evolving technologies in molecular diagnostic testing, next-generation sequencing, digital radiology, and software including DNA analysis and artificial intelligence," states Jeff Fischer, President of Longhorn Vaccines and Diagnostics LLC. "Industry competition which relies on quality peer- reviewed science, and trusted, transparent, and unbiased regulatory review such as the US FDA 510(k) process is essential to the rapid adoption of emerging technologies and maximizing the value of government and donor funding to truly make a difference for those that are and those that will be afflicted with this terrible, highly curable disease."

Statistics from the United States Center for Disease Control (CDC) state that one quarter of the world's population was infected with TB in 2016, and over 10 million people progressed to active infection with 1.7 million deaths.  According to Peter Sands, Executive Director of the Global Fund, "We've been making progress on 'bending the curve' on TB. Now we should 'break the curve' and achieve a decisive shift in trajectory towards ending the epidemics."

In 2016, the World Health Organization estimated that 4.3 million patients with active TB go undiagnosed.  To diagnose TB in many parts of the world, it is recognized that safe, efficient, reliable sample transportation is critical. "It is clear that we need to invest in systems for rapid, reliable transport of samples up the referral chain," states Madhukar Pai, a professor of epidemiology, and Director of McGill Global Health Programs and colleagues. Multiple technologies will need to be employed to cover the entire range of testing platforms and the varying environmental conditions where patients will be sampled.

The unique characteristics of PrimeStore^® MTM allow safe and efficient ambient temperature transport anywhere in the world, thus improving access to timely and sensitive TB diagnostic testing. Studies have demonstrated that PrimeStore^® MTM is compatible with the Cepheid GeneXpert point of care system, or higher throughput qPCR systems run in hospitals and centralized laboratories.  Many sputum samples collected for molecular testing for TB do not meet the standard volume requirements. Published studies have shown that tests on the Xpert MTB/Rif cartridge, as well as qPCR testing can be conducted with as little as 1/10 the sample amount used in standard procedures after being placed in PrimeStore^® MTM.

Transporting live infectious agents for testing can facilitate the spread of unknown pathogens from one region to another.  As TB is highly infectious and can be resistant to many or all current antimicrobials, inactivating all of the pathogens in the sample and stabilizing the RNA and DNA improves safety at all stages of the transport and testing process (healthcare worker and laboratory technician safety is an essential issue) and allows a single sample to be tested multiple times for TB and for other respiratory pathogens that can co-infect TB patients. 

LHNVD is prepared to engage with The Global Fund, as well as other funding entities, to negotiate PrimeStore^® MTM pricing to support the effort to "break the curve" on TB and positively impact the fight against the wide range of endemic and epidemic diseases around the world. While PrimeStore^® MTM is cost effective at current pricing, as it reduces costs throughout the healthcare process, LHNVD will seek to negotiate pricing that will reflect the high-volume purchase of samples that will need to be collected for molecular detection and characterization of TB, and other endemic and emerging regional and global microbial threats.

About PrimeStore^® MTM

PrimeStore® MTM is FDA cleared and intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA.  PrimeStore^® MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.

Peer reviewed journal articles, abstracts, posters, and vaccine development clinical trials have demonstrated PrimeStore® MTM's ability to generate highly sensitive results with multiple pathogens and sample types on several Real-Time PCR platforms to include Roche's LightCycler and Thermo Fisher's ABI 7500, as well as next-generation sequencers including Thermo Fisher's Ion Torrent and Illumina's MiSeq.  PrimeStore^® MTM has been demonstrated to be compatible with manual and high-throughput extractions systems from LHNVD, Qiagen, Thermo Fisher, bioMeriuex, and Roche.  Published studies have shown it to be compatible with Cepheid's GeneXpert MTB/RIF test.

LHNVD has received over 25 issued patents Worldwide (including the US, EU, China, India, South Africa, Canada and Australia) for the composition and use of PrimeStore^® MTM.

About LHNVD
Longhorn Vaccines and Diagnostics is a closely held, Veterans' Owned, Limited Liability Company headquartered in Bethesda, MD with laboratories in San Antonio, TX and Gaithersburg, MD.