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FDA Approves Quidel's C. difficile Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Quidel's molecular diagnostic assay for detecting Clostridium difficile infections for sale in the US, the San Diego-based company said today.

Quidel said the AmpliVue C. difficile test combines isothermal helicase dependent amplification with the company's lateral flow technology in a hand-held assay.

Often associated with the use of antibiotic therapies and long hospital stays, C. difficile causes nausea, fever, diarrhea, and abdominal pain caused by inflammation in the colon. The infections this bacterium causes can be deadly, particularly among the elderly and those with weak immune systems or on prolonged antibiotic regimens, and it has been linked to 14,000 deaths in the US annually, the company said.

The AmpliVue technology uses a molecular method that requires no nucleic acids extraction step to offer a "fast and sensitive result," the company said.

"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," Quidel President and CEO Douglas Bryant said in a statement.

Quidel said the test is now for sale in the US and Europe, and it is the first of Quidel's assays sold for the hand-held AmpliVue format.