Life Technologies Launches CE-IVD Marked QuantStudio™ 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 (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 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
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:
http://www.lifetechnologies.com.
Life Technologies' Safe Harbor
Statement
This press release includes forward-looking statements about
Life 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 by Life Technologies with the
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undertakes no obligation to update or revise any such
forward-looking statements to reflect subsequent events or
circumstances.
SOURCE Life Technologies