World TB Day 2018

US Food and Drug Administration Clears PrimeStore® MTM, an Important New Device in the Worldwide Fight Against Mycobacterium Tuberculosis

As Governments around the world push to eliminate TB, PrimeStore^® MTM serves as a crucial new tool to facilitate safe and accurate TB diagnosis and expedite detection of M. tuberculosis drug resistance gene mutations

BETHESDA, Maryland, March 22, 2018 /PRNewswire/ -- 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."