Quidel Receives FDA Clearance for Its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Clostridium Difficile
December 17 2012 - 1:00PM
Marketwired
Quidel Corporation (NASDAQ: QDEL)
, a leading provider of rapid diagnostic testing
solutions and cellular-based virology assays, announced today that
it has received 510(k) clearance from the United States Food and
Drug Administration (FDA) for the sale of Quidel's non-instrumented
molecular diagnostic test -- the AmpliVue C. difficile Assay -- for
the detection of toxigenic Clostridium difficile bacterial DNA.
Detection of the pathogen is achieved using a hand-held, fully
contained cassette that combines isothermal Helicase Dependent
Amplification (HDA) with its lateral flow detection technology.
C. difficile infection is frequently associated with antibiotic
therapy and prolonged hospital stays. Typical symptoms include
nausea, fever, watery diarrhea and abdominal pain due to
inflammation of the colon.
Clostridium difficile bacterial infections can be life
threatening, especially for the elderly, for the immunocompromised,
and for patients on a prolonged antibiotic regimen. "According to
the Centers for Disease Control and Prevention, C. difficile causes
diarrhea linked to 14,000 deaths in the U.S. each year,"(1) said
Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer for
Quidel, who added "for this reason, accurate and fast diagnosis --
like that provided by AmpliVue -- is vital to the patient's proper
treatment and recovery."
Traditional methods for diagnosing C. difficile infections, such
as glutamate dehydrogenase (GDH) or toxin antigen tests, can lack
sensitivity and increase lab costs due to additional confirmation
testing. In addition to significant technical expertise,
cytotoxicity assays and toxigenic culture require 24-48 hours and
3-5 days, respectively, before reliable results can be obtained.
The AmpliVue C. difficile Assay will now enable laboratories to
offer a fast and sensitive result generated by molecular methods
using actual kit components, without the need to purchase and
maintain expensive capital equipment. The assay also requires no
upfront nucleic acid extraction step.
"We are very pleased to receive 510(k) clearance for the first
hand-held molecular device for C. difficile," said Douglas Bryant,
president and chief executive officer of Quidel Corporation. "The
AmpliVue C. difficile Assay will allow hospitals currently using
traditional detection methods to employ a more sensitive, rapid
molecular test, thereby providing laboratory technicians and the
physicians they serve with accurate, timely, and reliable diagnosis
of C. difficile infections."
The C. difficile assay is Quidel's first assay in the hand-held
AmpliVue format, and is now available for sale in the U.S. and
Europe.
(1) http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_infect.html
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®, D3® Direct Detection and Thyretain® leading brand names,
as well as under the new Sofia® and AmpliVue® 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 quidel.com and Diagnostic Hybrids at dhiusa.com.
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 molecular-based technology, the medical reimbursement
system currently in place and future changes to that system,
manufacturing and production delays or difficulties, adverse
actions or delays in product reviews by the U.S. Food and Drug
Administration (the "FDA"), our ability to comply with FDA,
environmental and other regulations, our ability to meet unexpected
increases in demand for our products, our ability to execute our
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 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.
2252ID1112D (12/12)
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer (858) 552-7931 Media and Investors Contact: Quidel
Corporation Ruben Argueta (858) 646-8023 Email Contact
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