Quidel wins 510(k) for C. difficile molecular Dx

Quidel ($QDEL) won a coveted 510(k) clearance from the FDA for a new hand-held molecular diagnostic test to detect DNA for Clostridium difficile bacteria.

Known formally as the AmpliVue C. difficile Assay, the diagnostic is already approved for use in Europe and is now being rolled out for sale in the U.S. and overseas. The non-instrumented molecular diagnostic is designed to be quicker than current technology such as glutamate dehydrogenase or toxin antigen tests, which can take a few days to obtain usable results. Clinicians just use the test's kit components to do their work.

FierceMedicalDevices tried unsuccessfully to reach Quidel for this story. But President and CEO Douglas Bryant said in a prepared statement that he sees the test as enabling hospitals to rely on a much more rapid test in order to quickly spot the infections (and, presumably, hopefully reduce their occurrence.)

For C. difficile, time is of the essence. The hospital-acquired infection can be particularly deadly to older people, patients with a compromised immune system and those who have been on antibiotics for a while. Numbers cited by Quidel from the Centers for Disease Control and Prevention note that at least 14,000 people die each year in the U.S. from C. difficile-related diarrhea.

And so the development of rapid diagnostic tests for C. difficile has attracted a number of emerging players in the space. PrimeraDx--a FierceMedicalDevices 2012 Fierce 15 company--recently gained CE marks for its ICEPlex diagnostics platform and an accompanying test to detect C. difficile. PrimeraDx has raised $53 million since its 2004 launch; ICEPlex combines polymerase chain reaction and capillary electrophoresis into a single unit. The company's C. difficile test uses ICEPlex to test for C. difficile on nucleic acids purified from human stool samples.

- read the release

Special Report: PrimeraDx – 2012 Fierce 15

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