Life Technologies Corporation today announced the launch of its Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument designed to meet the specific needs of clinical diagnostic laboratories. The instrument is CE-IVD marked for use in Europe and represents a significant extension of Life Technologies' product offerings in the diagnostics arena.
"Molecular diagnostic tests based on real-time PCR have become indispensable to the clinical lab," said Ronnie Andrews, president of Medical Sciences at Life Technologies. "Molecular testing is the fastest-growing segment of the diagnostics market, and the QuantStudio™ Dx instrument has unique features that will allow us to capture that market growth."
The global IVD (in vitro diagnostic) market is approximately $52 billion and is expected to reach $70 billion by 2015. The current European IVD market is approximately $14 billion and expected to reach $17 billion by 2015.
The QuantStudio™ Dx Real-Time PCR Instrument can perform numerous diagnostic functions, including pathogen detection, 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's touchscreen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface are specifically designed for ease of use. 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 without the need for liquid-handling robots. The card can also be used to design and implement custom tests. Life Technologies is currently developing diagnostic tests utilizing this format.
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 QuidelÂ® 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 AcroMetrixÂ® 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."