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Quidel (QDEL) Receives FDA Clearance For Clostridium Difficile Hand-Held Molecular Diagnostic Test

 December 17, 2012 02:41 PM
 


(By Balaseshan) Quidel Corp. (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, said it has received U.S. Food and Drug Administration (FDA) clearance for its AmpliVue hand-held molecular diagnostic test for clostridium difficile.

The company has received 510(k) clearance from 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. 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.

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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.

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.

[Related -Quidel (QDEL) Receives CE Mark For Sofia RSV Fluorescent Immunoassay Test]

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.

QDEL is trading up 1.82% at $18.50 on Monday. The stock has been trading between $14.08 and $19.37 for the past 52 weeks.

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