Life Technologies Launches CE-IVD Marked QuantStudio(TM) Dx Real-Time PCR Instrument in Europe
CARLSBAD, California, November 19, 2012 /PRNewswire/ –
Flagship qPCR instrument offers reliability, accuracy, ease of use and
flexibility for IVD and lab-developed diagnostic tests
Life Technologies Corporation [http://www.lifetech.com ] (NASDAQ:LIFE
[http://finance.yahoo.com/q?s=life ]) today announced the launch of its Applied Biosystems
QuantStudio(TM) 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
“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(TM) Dx instrument has unique features that will allow us to capture that
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(TM) 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(TM) Dx Software
runs IVD (in vitro diagnostic) tests in a secure mode with pre-set run and analysis
parameters, while the QuantStudio(TM) 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(TM) Dx instrument addresses both these needs.”
The instrument is being released with CE-marked Quidel(R) 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(TM) Dx Real-Time PCR Instrument for
510(k) clearance to the United States Federal Food and Drug Administration (FDA) in
The QuantStudio(TM) 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(R) 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
DeciBio LLC, Molecular Diagnostics: Market Size, Segmentation, Growth and
Opportunities, February 2012
About Life Technologies
Life Technologies Corporation
[http://www.lifetechnologies.com/us/en/home.html?cid=fl-home%3fCID=fl-home ] (NASDAQ: LIFE)
is a global biotechnology company with customers in more than 160 countries using its
innovative solutions to solve some of today’s most difficult scientific challenges.
Quality and innovation are accessible to every lab with its reliable and easy-to-use
solutions spanning the biological spectrum with more than 50,000 products for agricultural
biotechnology, translational research, molecular medicine and diagnostics, stem cell-based
therapies, forensics, food safety and animal health. Its systems, reagents and consumables
represent some of the most cited brands in scientific research including: Ion Torrent(TM),
Applied Biosystems(R), Invitrogen(TM), GIBCO(R), Ambion(R), Molecular Probes(R), Novex(R),
and TaqMan(R). Life Technologies employs approximately 10,400 people and upholds its
ongoing commitment to innovation with more than 4,000 patents and exclusive licenses. LIFE
had sales of $3.7 billion in 2011. Visit us at our website:
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contained in this press release, including, but not limited to, statements as to industry
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business, contains forward-looking statements that are subject to risks and uncertainties
that could cause actual results or events to differ materially from those expressed or
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SOURCE Life Technologies