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Life Technologies Launches CE-IVD Marked QuantStudio™ Dx Real-Time PCR Instrument In Europe

Two software options are available on the instrument. The QuantStudio™ Dx Software runs IVD ( in vitro diagnostic) tests in a secure mode with pre-set run and analysis parameters, while the QuantStudio™ Test Development Software enables development of custom tests and supports clinical research projects.

"We recognize that clinical laboratories have multiple needs," said Andrews. "Accuracy and reliability are paramount when running diagnostic tests for physician reporting. In addition medical research labs need instrumentation that supports experimental work. The QuantStudio™ Dx instrument addresses both these needs."

The instrument is being released with CE-marked Quidel® Molecular Assay for C. difficile for detection of hospital-acquired infections, which Life Technologies distributes. Additional Quidel Molecular infectious disease applications are currently under development and will be available in 2013, 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.

Life Technologies plans to submit the QuantStudio™ Dx Real-Time PCR Instrument for 510(k) clearance to the United States Federal Food and Drug Administration (FDA) in December 2012.

The QuantStudio™ Dx Real-Time PCR Instrument is among a growing line of Life Technologies platforms for diagnostic use. The Applied Biosystems 3500 Dx Genetic Analyzer, a Sanger sequencing instrument, is currently CE-IVD marked. The company also offers the AcroMetrix® line of quality controls for molecular diagnostic assays.

"The Life Technologies Applied Biosystems brand has a 30-year heritage of leadership in the PCR market," said Andrews. "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. In short, Life Technologies has the capability and the commitment to fully equip the diagnostic lab of the future."

For more information, please visit http://www.lifetechnologies.com/quantstudiodx.html.

[ 1 ]DeciBio LLC, Molecular Diagnostics: Market Size, Segmentation, Growth and Opportunities, February 2012

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