Quidel Corporation
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.
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