Game Changing Tuberculosis Assay Validated for Illumina's MiSeq Platform - Seite 2

PrimeSeqMDR has been developed and optimized from samples transported in PS-MTM, the first FDA cleared sample collection, transport, and storage device for samples suspected of containing MTB.  Direct clinical specimens, as well as samples from culture, can be transported in PS-MTM at ambient temperature to a laboratory with an Illumina MiSeq for rapid analysis and since PS-MTM inactivates/kills microbes, special handling or containment procedures are not required.  Facilities with containment and special handling capabilities can use PrimeSeqMDR with samples that are not transported in PS-MTM.

LHNVD is in the process of establishing distribution and manufacturing for PrimeSeqMDR, PS-MTM, and its other MTB products in large MTB endemic countries and regions. 

About PrimeSeqMDR

PrimeSeqMDR is a targeted gene sequencing (TGS) kit developed for the Illumina MiSeq  Next Generation Sequencing system to determine M. tuberculosis drug sensitivity from clinical and cultured specimens.  It is optimized to reduce time and cost and is most effective when used with the PrimeStore MTM collection and transport device and the highly sensitive, open platform PrimeMix TB qPCR reagent set.

About PrimeStore MTM

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

Peer reviewed journal articles, abstracts, posters, and vaccine development clinical trials have demonstrated PS-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.   PS-MTM has been demonstrated to be compatible with manual and high-throughput extractions systems from LHNVD, Qiagen, Thermo Fisher, bioMérieux, and Roche.  Published studies have shown it to be compatible with Cepheid's GeneXpert MTB/RIF test using a fraction of the sputum necessary for the standard workflow.

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.  LHNVD diagnostic division develops technologies to optimize molecular testing in the developed and developing world.

www.lhnvd.com