Flagship qPCR instrument offers reliability, accuracy, ease of use and
flexibility for IVD and lab-developed diagnostic tests
CARLSBAD, CA, Nov. 19, 2012 /CNW/ - 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
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
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
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)
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.
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
Securities and Exchange Commission. Life Technologies undertakes no
obligation to update or revise any such forward-looking statements to
reflect subsequent events or circumstances.
SOURCE: Life Technologies
For further information:
Life Technologies Contact: Suzanne Clancy, +1-760-602-4545, +1-858-205-4235 (mobile), email@example.com