NEW YORK (GenomeWeb) - Longhorn Vaccines and Diagnostics announced today it has received de novo clearance from the US Food and Drug Administration for its PrimeStore Molecular Transport Medium for stabilizing microbial nucleic acids.
PrimeStore MTM inactivates pathogens and stabilizes RNA and DNA for downstream molecular testing. It begins to inactivate pathogens immediately, allowing a sample to be tested within minutes of collection or shipped at ambient temperature to a testing facility anywhere in the world, the company said. It also "provides healthcare providers, vaccine and drug developers, laboratories, and assay developers a key new component to the molecular testing process that can expand both point-of-care and laboratory testing without subjecting workers to live infectious agents," according to Longhorn.
The medium has been cleared for unprocessed nasal washes suspected of containing influenza A virus RNA as well as for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA.
The company noted that it had worked closely with the Center of Devices and Radiological Health over the last two years to define a new class of molecular transport device specific for the molecular testing field, with the filing focusing on specimens suspected of containing influenza A or M. tuberculosis.
The medium has been shown to be compatible with several real-time PCR platforms, including Roche's LightCycler and Thermo Fisher Scientific's ABI 7500, as well as next generation sequencers including Thermo Fisher's Ion Torrent and Illumina's MiSeq. It has also been demonstrated to be compatible with manual and high-throughput extractions systems from Qiagen, Thermo Fisher, BioMerieux, and Roche, and published studies have shown it to be compatible with Cepheid's GeneXpert MTB/RIF test, the firm said.
Longhorn said it plans to seek expanded labeling for additional pathogens and sample types including multiple respiratory samples, blood, fecal, urine, tissue, and dry skin swabs for STI testing, "all of which have been successfully inactivated and the nucleic acid preserved in PrimeStore MTM in research studies."