Biotechnology company Life Technologies has introduced a new real-time PCR-based molecular diagnostic instrument for diagnostic use.
Available with the Quidel Molecular assay for C. difficile, the CE-IVD-marked Applied Biosystems QuantStudio Dx instrument 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 instrument also includes software which runs in vitro diagnostic tests in a secure mode with pre-set run and analysis parameters, while QuantStudio test development software enables development of custom tests and supports clinical research projects.
The instrument’s flexibility is enabled through easily interchangeable thermal cycling blocks that accommodate 96 or 384-well plates and a proprietary qPCR microfluidics card which can perform 48 tests on eight samples simultaneously, according to the company.
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) and respiratory syncytial virus (RSV) assay, 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 for 30-years 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.
"In short, Life Technologies has the capability and the commitment to fully equip the diagnostic lab of the future."
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.