Life Technologies Launches CE-IVD Marked QuantStudio™ Dx Real-Time PCR
Instrument in Europe
CARLSBAD, California, November 19, 2012
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 (NASDAQ: LIFE ) 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.
(Logo: http://photos.prnewswire.com/prnh/20110216/MM49339LOGO )
"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. ^[ ^1 ^]
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
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
"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
^[ ^1 ^] DeciBio LLC, Molecular Diagnostics: Market Size, Segmentation, Growth
and Opportunities, February 2012
About Life Technologies
Life Technologies Corporation (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™, Applied Biosystems®,
Invitrogen™, GIBCO®, Ambion®, Molecular Probes®, Novex®, and TaqMan®. 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:
Life Technologies' Safe Harbor Statement
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Technologies' anticipated results that involve risks and uncertainties. Some
of the information contained in this press release, including, but not limited
to, statements as to industry trends and Life Technologies' plans, objectives,
expectations and strategy for its 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 implied by such
forward-looking statements. Any statements that are not statements of
historical fact are forward-looking statements. When used, the words
"believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and
the like, and/or future tense or conditional constructions ("will," "may,"
"could," "should," etc.), or similar expressions, identify certain of these
forward-looking statements. Important factors which could cause actual results
to differ materially from those in the forward-looking statements are detailed
in filings made byLife Technologies with the Securities and Exchange
Commission.Life Technologies undertakes no obligation to update or revise any
such forward-looking statements to reflect subsequent events or circumstances.
Contact: Life Technologies Contact: Suzanne Clancy, +1-760-602-4545,
+1-858-205-4235 (mobile), firstname.lastname@example.org
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