PrimeStore MTM has been demonstrated to be effective in published peer-reviewed clinical studies under the most challenging conditions. Why did you seek FDA clearance?

Jeff Fischer: Longhorn Vaccines and Diagnostics (LHNVD) developed PrimeStore MTM over ten years ago to provide better RNA and DNA for molecular testing. Peer-reviewed studies conducted using the leading molecular platforms to include next-generation sequencing have demonstrated that samples collected in PrimeStore MTM provide highquality quantitative polymerase chain reaction (qPCR) and next-generation sequencing results. Whether the sample is collected and tested on-site or shipped at ambient temperature thousands of miles, clinical studies have generated highly sensitive microbial detection results without the need for pathogen containment or special handling procedures.

Over the past three years, several high-profile diagnostic companies have made outlandish, unsupported claims about their technology. Sample collection was and continues to be a field plagued with questionable technology. LHNVD approached FDA and worked closely with the agency to define a new category of device through PrimeStore MTM, setting a high bar for future products.

Your first indications focused on influenza and Mycobacterium tuberculosis (MTB). Why did you choose these pathogens?

PrimeStore MTM was originally developed to protect RNA in samples suspected of containing the influenza virus. Extensive work has been done in the developed and developing world, demonstrating samples shipped in PrimeStore MTM generate highly sensitive results for influenza viruses, and a wide range of respiratory pathogens in a variety of qPCR uniplex and multiplex tests.

After PrimeStore MTM was initially FDA-reviewed and authorised as part of the 2009-10 H1N1 pandemic, LHNVD shifted to systematic validation of PrimeStore MTM as part of the World Health Organization’s urgent call for new products to combat the epidemic of MTB infection in the developing world. PrimeStore MTM’s inactivation characteristics are ideal for MTB and the developing world. Collecting and transporting samples in PrimeStore MTM has two key advantages compared with handling raw sputum: safety and sensitivity. Many laboratories and near-care facilities lack containment facilities for handling highly infectious samples. Samples in PrimeStore MTM require no containment for safe handling. MTB can be a challenging pathogen to fully lyse. For samples containing low levels of MTB that aren’t fully lysed, crucial DNA is not released, and cannot be detected. Samples in PrimeStore MTM are fully lysed, and the DNA is released and protected for highly sensitive molecular testing.

How can PrimeStore MTM be used to improve clinical outcomes?

Current respiratory samples are collected in universal transport media/viral transport media (UTM/VTM), which is a legacy media designed for culturing microbes. Studies have demonstrated that UTM/VTM inhibit molecular detection, reducing sensitivity of tests. Influenza drugs are most effective when the infection is detected early. Peerreviewed studies demonstrated enhanced detection of the influenza virus in pre-symptomatic family members of symptomatic patients using qPCR with samples collected in PrimeStore MTM.

For MTB, PrimeStore MTM provides highly sensitive disease detection using a fraction of standard sputum volume required for other tests. Samples that test positive can be further tested for drug sensitivity by a number of molecular technologies to include next-generation sequencing. Rapidly determining effective treatment protocols is essential to cure rates.

PrimeStore MTM has allowed you to develop a new product that will dramatically improve MTB drug sensitivity testing (DST). What can you tell us about PrimeSeqMDR?

PrimeSeqMDR is a game-changing DST kit for MTB. It can be used with the highly sensitive, clinically validated open platform PrimeSuite MTB qPCR assay, or after MTB detection by a wide range of tests to include smears, culture or molecular detection. For non-molecular testing, a portion of the smear sample or culture sample can be added to PrimeStore MTM. Samples for molecular detection can be immediately placed in PrimeStore MTM.

PrimeSeqMDR provides timely and cost-effective DST for key MTB drugs, which include pyrazinamide (PZA). It is designed to be used with the industry-leading Illumina MiSeq instrument.