Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile Assay and Quantstudio(TM) DX and 7500 Fast DX Real

Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile 
Assay and Quantstudio(TM) DX and 7500 Fast DX Real-Time PCR
Instruments 
FDA Issues 510(k) Clearance for Quidel Molecular Direct Clostridium
difficile Assay and Life Technologies Real-Time PCR Instruments for
Monitoring Hospital-Acquired Infections 
SAN DIEGO, CA and CARLSBAD, CA -- (Marketwire) -- 03/18/13 --  Quidel
Corporation (NASDAQ: QDEL) and Life Technologies Corporation (NASDAQ:
LIFE) announced today that they received 510(k) clearances from the
United States Food and Drug Administration (FDA) to market the Quidel
Molecular Direct C. difficile Assay with Life Technologies'
QuantStudio(TM) Dx and 7500 Fast Dx Applied Biosystems(R) Real-Time
PCR Instruments.  
Clostridium difficile bacterial infections are life-threatening,
especially for the elderly, immunocompromised populations, and for
patients on a prolonged antibiotic regimen. C. difficile infection
(CDI) is frequently associated with antibiotic therapy and extended
hospital stays. 
"According to The Centers for Disease Control and Prevention (CDC),
14,000 deaths are attributed to CDI in the U.S. each year, which
costs the national healthcare system about $1 billion in excess
treatment. For this reason, a fast and accurate diagnosis is vital to
the patient's proper treatment and speedy recovery,"(1) said Douglas
Bryant, president and chief executive officer for Quidel Corporation,
who added, "With the clearance of our C. difficile assay, we extend
our Quidel Molecular product line beyond respiratory infections with
products that address the needs of hospital laboratories in
higher-volume settings." 
"Molecular diagnostic assays have become the gold standard for
infectious disease testing in 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
Life Technologies' deep expertise in real-time PCR instrumentation,
together with our demonstrated effectiveness in pursuing regulatory
pathways for our instruments, uniquely positions Life to become a
leader in the diagnostics market." 
This Quidel Molecular Direct C. difficile Assay is part of Quidel's
expanding line of molecular diagnostics products. The Quidel
Molecular product line offers PCR reagent kits for use by molecular
diagnostic laboratories, including Life Technologies' QuantStudio(TM)
Dx and 7500 Fast Dx. These reagents provide attractive features that
include refrigerated storage instead of freezing, convenient
ready-to-use reagents, a short time to result, and other benefits
that favorably enhance the molecular workflow.  
The Quidel Molecular Direct C. difficile Assay kit includes an
extraction-free, three-step sample preparation process that requires
no heat step, no timed step, and no centrifugation as an added
benefit. This fast and easy direct-to-amplification procedure allows
the assay to generate a result in less than 70 minutes by an
efficient and economical method. 
"Combining multiple system capabilities in a single footprint, the
QuantStudio(TM) Dx is our flagship instrument in the diagnostic lab
market," said Andrews. "Life Technologies is committed to providing
physicians and clinical laboratories with instrumentation designed
for flexibility and ease of use, as well as best-in-class diagnostic
tests where we see unmet clinical need." 
The QuantStudio(TM) Dx Real-Time PCR instrument's touch screen,
reagent and sample tracking, and LIMS (Laboratory Information
Management Systems) interface are specifically designed for ease of
use, and the six-color feature allows for a multiplex of six targets
in one reaction.  
The 7500 Fast Dx Real-time PCR Instrument system is a five-color
real-time PCR instrument that delivers the performance required for
high-quality results in a 96-well format. The 7500 Fast Dx is also
FDA cleared for diagnostic use with the Center for Disease Control's
H1N1 assay and with the Quidel Molecular assays for Influenza A+B and
human metapneumovirus (hMPV).  
With the QuantStudio(TM) Dx, flexibility is enabled through an
optional Test Development mode allowing the use of 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. In this Test Development
mode, the QuantStudio(TM) Dx can perform numerous 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 current 510(k) clearance represents another milestone in the
extension of Life Technologies' move into the diagnostics arena. In
September 2012, Life Technologies launched Pervenio(TM) Lung RS, a
lab-developed test distinguishing high-risk from low-risk early stage
lung cancer patients. In February 2013, the company received 510(k)
clearance for its 3500 Dx Genetic Analyzers and SeCore(R) HLA typing
kits.  
The Quidel Molecular Direct C. difficile Assay is Quidel's first
assay with a streamlined stool processing procedure. Quidel also
sells FDA approved molecular tests in the Real-Time PCR format for
Influenza A+B, hMPV and RSV + hMPV.  
(1)
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6109a3.htm?s_cid=mm6109a3_w 
About Life Technologies 
 Life Technologies Corporation (NASDAQ:
LIFE) is a global biotechnology company that is committed to
providing the most innovative products and services to leading
customers in the fields of scientific research, genetic analysis and
applied sciences. With a presence in more than 180 countries, the
company's portfolio of 50,000 end-to-end solutions is secured by more
than 5,000 patents and licenses that span the entire biological
spectrum -- scientific exploration, molecular diagnostics, 21st
century forensics, regenerative medicine and agricultural research.
Life Technologies has approximately 10,000 employees and had sales of
$3.8 billion in 2012. 
About Quidel Corporation
 Quidel Corporation serves to enhance the
health and well being of people around the globe through the
development of diagnostic solutions that can lead to improved patient
outcomes and provide economic benefits to the healthcare system.
Marketed under the QuickVue(R), D3(R) Direct Detection and
Thyretain(R) leading brand names, as well as under the new Sofia(R)
and AmpliVue(R) brands, Quidel's products aid in the detection and
diagnosis of many critical diseases and conditions, including, among
others, influenza, respiratory syncytial virus, Strep A, herpes,
pregnancy, thyroid disease and fecal occult blood. Quidel's research
and development engine is also developing a continuum of diagnostic
solutions from advanced lateral-flow and direct fluorescent antibody
to molecular diagnostic tests to further improve the quality of
healthcare in physicians' offices and hospital and reference
laboratories. For more information about Quidel's comprehensive
product portfolio, visit www.quidel.com and Diagnostic Hybrids at
www.dhiusa.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. 
Quidel Forward-Looking Statement
 This press release contains
forward-looking statements within the meaning of the federal
securities laws that involve material risks, assumptions and
uncertainties. Many possible events or factors could affect our
future financial results and performance, such that our actual
results and performance may differ materially from those that may be
described or implied in the forward-looking statements. As such, no
forward-looking statement can be guaranteed. Differences in actual
results and performance may arise as a result of a number of factors
including, without limitation, seasonality, the timing of onset,
length and severity of cold and flu seasons, the level of success in
executing on our strategic initiatives, our reliance on sales of our
influenza diagnostic tests, uncertainty surrounding the detection of
novel influenza viruses involving human specimens, our ability to
develop new products and technology, adverse changes in the
competitive and economic conditions in domestic and international
markets, our reliance on and actions of our major distributors,
technological changes and uncertainty with research and technology
development, including any future molecular-based technology, the
medical reimbursement system currently in place and future changes to
that system, manufacturing and production delays or difficulties,
adverse regulatory actions or delays in product reviews by theU.S.
Food and Drug Administration (the "FDA"), compliance with FDA and
environmental regulations, our ability to meet unexpected increases
in demand for our products, our ability to execute our growth
strategy, including the integration of new companies or technologies,
disruptions in the global capital and credit markets, our ability to
hire key personnel, intellectual property, product liability,
environmental or other litigation, potential required patent license
fee payments not currently reflected in our costs, adverse changes in
our international markets, potential inadequacy of booked reserves
and possible impairment of goodwill, and lower-than-anticipated
acceptance, sales or market penetration of our new products.
Forward-looking statements typically are identified by the use of
terms such as "may," "will," "should," "might," "expect,"
"anticipate," "estimate," and similar words, although some
forward-looking statements are expressed differently. The risks
described under "Risk Factors" in reports and registration statements
that we file with the Securities and Exchange Commission (SEC) from
time to time should be carefully considered. You are cautioned not to
place undue reliance on these forward-looking statements, which
reflect management's analysis only as of the date of this press
release. We undertake no obligation to publicly release the results
of any revision or update of the forward-looking statements, except
as required by law.  
Life Technologies Contact
Suzanne Clancy
760-602-4545
858-205-4235 (mobile)
suzanne.clancy@lifetech.com 
Quidel Contact:
Ruben Argueta
858-646-8023
rargueta@quidel.com 
 
 
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