Life Technologies has introduced a new real-time PCR based molecular diagnostic instrument for diagnostic use in the Europe.
The Applied Biosystems QuantStudio Dx instrument, which is released with Quidel Molecular assay for C. difficile, features a touchscreen, reagent and sample tracking, and laboratory information management system interface.
In addition to pathogen detection, the instrument performs various diagnostic functions including gene expression analysis, SNP genotyping, copy number analysis, mutation detection, micro-RNA and other non-coding RNA analysis and high-resolution melt analysis.
The company is also planning to release the instrument’s usage in other Quidel Molecular infectious disease applications including an influenza A + B Assay, a human metapneuomvirus (hMPV) + respiratory syncytial virus (RSV) assay, and a herpes simplex virus 1 and 2, and varicella zoster virus (chicken pox and shingles) assay in 2013.
Life Technologies medical sciences president Ronnie Andrews said the company’s Applied Biosystems brand products have been used since 30-year in the PCR market.
"We also have a broad partnership base in the diagnostic and pharmaceutical space that will support content development across our Sanger and next generation sequencing instruments – platforms that we expect will play an increasingly important role in the clinic," Andrews added.
The company is planning to submit the QuantStudio Dx instrument’s 510(k) application to the US Federal Food and Drug Administration (FDA) in December 2012.