Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Sanger Sequencing Platform and HLA Typing Kits

 Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Sanger
                   Sequencing Platform and HLA Typing Kits

Life's Applied Biosystems™3500 Dx Genetic Analyzer and SeCore® kits constitute
first sequence-based system cleared for HLA typing

PR Newswire

CARLSBAD, Calif., Feb. 11, 2013

CARLSBAD, Calif., Feb. 11, 2013 /PRNewswire/ --Life Technologies Corporation
(NASDAQ: LIFE) today announced that it has received U.S. Food and Drug
Administration (FDA) 510(k) clearance for its 3500 Dx Genetic Analyzers and
SeCore® HLA typing kits. The development represents additional execution
against the company's strategy to become a leader in the diagnostics market by
offering both novel clinical assays and best- in-class molecular testing

"This successful application for our Sanger sequencer with HLA typing kits is
further demonstration of Life Technologies' track record in obtaining FDA
regulatory clearance for genetic analysis in the clinical market," said Greg
Lucier, chairman and chief executive officer of Life Technologies. "We will
continue to aggressively pursue a regulatory pathway for our leading
technologies in the clinical space, including next-generation sequencing."

The company's 7500 Fast Dx Real-time PCR system was cleared for diagnostic use
with the Center for Disease Control's H1N1 assay in 2008. Life Technologies
has also announced plans to submit its next-generation sequencing instrument,
the Ion Torrent Personal Genome Machine (PGM™) for 510(k) clearance.

The Applied Biosystems™ 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen
SeCore® HLA Sequencing Kits, and uTYPE® Dx HLA Sequence Analysis Software
constitute the first 510(k)-cleared, sequence-based system for HLA typing in
the United States. Tissue typing is an essential component of determining
compatibility between donors and patients for organ and bone marrow
transplantation. HLA typing on the 3500 Dx offers labs an optimized,
streamlined workflow with higher resolution than other molecular HLA typing
technologies such as sequence-specific oligonucleotide (SSO) methods.

"With clearance of this system, transplant patients can now have the
confidence that their HLA tissue typing was performed utilizing a thoroughly
tested, high resolution technique that has passed the strict test requirements
of the FDA," said Ronnie Andrews, president of medical sciences at Life
Technologies. "Precise HLA matching between donor and patient significantly
improves overall transplant survival."

The 3500 Dx is now the only 510(k)-cleared Sanger sequencer commercially
available for the diagnostics market. Sanger, also known as capillary
electrophoresis, sequencing is the technology that powered the Human Genome
Project and remains the "gold-standard" for its accuracy, reliability and ease
of use. It is expected that clearance will facilitate development of
additional assays using the 3500 Dx and open up new partnerships with assay

"Sanger sequencing remains the gold standard for providing the reliable
results clinical labs need, and 510(k) clearance of the 3500Dx will help to
establish sequencing technology as a mainstay of the hospital lab," said
Andrews. "The instrument was designed with the clinical laboratory in mind,
featuring a novel design that incorporates the ability to track patient
samples with radio frequency identification (RFID) tags, as well as redesigned
data collection and analysis software."

Products included in the current 510(k) clearance are the 3500 Dx/3500xL Dx
Genetic Analyzers CS2; 3500 Dx Series Data Collection Software v1.0; SeCore®
HLA Sequencing Kits; and uTYPE® Dx HLA Sequence Analysis Software. The 3500 Dx
instrument is CE-marked for in vitro diagnostic use in Europe, has been
approved byChina'sState Food and Drug Administration (SFDA) for diagnostic
use inChina, and is also available in Japan, Australia, India, New Zealand,
Singapore, and Taiwan.

Additional products offered by Life Technologies for the diagnostics lab
market include: the Applied Biosystems QuantStudio™ Dx Real-Time PCR
Instrument, which is CE-IVD marked for use in Europe and under review by FDA;
the Veriti™ Dx Thermal Cyclers; and the AcroMetrix® line of quality controls
for molecular diagnostic assays. In addition, the EZ Validation™ Online Tool
is available for assisting in the validation and verification of molecular

Life Technologies' next-generation sequencing platforms include the Ion
Personal Genome Machine (PGM™) and Ion Proton™. These instruments are
currently marked for Research Use Only.

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® and Novex®. 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 $3.8 billion in 2012. Visit us at our website:

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 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.



Life Technologies Contact
Suzanne Clancy
858-205-4235 (mobile)

SOURCE Life Technologies Corporation

Press spacebar to pause and continue. Press esc to stop.