Life Technologies Corporation, a global biotechnology company, has introduced Instrument for Dx Real-Time PCR Applied Biosystems QuantStudio, designed to meet the specific needs of laboratories clinical diagnostics. The instrument is certified CE-IVD mark for use in Europe and represents a significant expansion of the product offerings of Life Technologies in the field of diagnosis.

"The molecular diagnostic tests based on real-time PCR have become indispensable for clinical laboratories," says Ronnie Andrews, president of Medical Sciences of Life Technologies. "Molecular tests are the fastest growing segment of the diagnostics market, and the instrument QuantStudio Dx has unique features that allow us to capture that market growth."

The global market for in vitro diagnostics (IVD) is approximately US$ 52,000 million and is expected to reach US$ 70,000 million for 2015. The current European IVD market is approximately US$ 14,000 million and is expected to rise to US$ 17,000 million for 2015.

The Instrument for Real Time PCR Dx QuantStudio can perform numerous diagnostic functions, including pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, microRNAs and other noncoding RNA analysis , and melting analysis with high resolution.

The touch screen of the instrument, reagent and sample tracking, and interface LIMS (Laboratory Information Management Systems), are designed specifically for use is easy. Flexibility is provided by thermal cyclic easily interchangeable blocks that support plates 96 or 384 wells and microfluidics an exclusive card qPCR can perform tests on eight samples 48 simultaneously without liquid handling robots. The card can also be used to design and implement customized tests. Life Technologies is currently developing diagnostic tests using this format.

There are two options available in the instrument software. The Dx Software QuantStudio IVD tests performed (diagnostic in vitro) securely with execution parameters and default analysis, while the Test Development Software QuantStudio allows the development of customized tests and supports clinical research projects.

"We recognize that clinical laboratories have multiple needs," says Andrews. "Accuracy and reliability are essential when performing diagnostic tests for medical reports. Addition, medical research laboratories need instrumentation that allows the experimental work. Instrument QuantStudio Dx addresses both needs."

The instrument is being launched with CE certification Quidel Molecular Assay for C. difficile to detect HAIs, which distributes Life Technologies. They are currently developing additional applications for Quidel Molecular infectious diseases, which will be available in 2013, including a test for influenza A + B assay for human metapneumovirus (hMPV) + respiratory syncytial virus (RSV), and a test for virus herpes simplex virus 1 and 2, and varicella zoster virus (chickenpox and shingles).

Life Technologies plans to send the instrument for Dx Real-Time PCR QuantStudio for 510 (k) to the Federal Food and Drug US (United States Federal Food and Drug Administration, FDA) in December 2012.

The Instrument for Real Time PCR Dx QuantStudio is a part of growing line of Life Technologies platforms for diagnostic use. Dx Genetic Analyzer Applied Biosystems 3500, an instrument sequencing Sanger , currently has CE certification-IVD. The company also offers line quality control for molecular diagnostic assays AcroMetrix.

"The trademark of Life Technologies Applied Biosystems has a history of 30 years of leadership in the PCR market," says Andrews. "We also have a broad base of partnerships in the diagnostic and pharmaceutical space that will support the development of content in our sequencing instruments Sanger and next-generation platforms that we expect to play an increasingly important role in the clinic. Briefly, Life Technologies has the ability and commitment to fully equip the diagnostic laboratory of the future."

Life Technologies Corporation is a global biotechnology company using its innovative solutions to solve some of the most complex scientific challenges of today.