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Quidel Obtains CE Mark for AmpliVue C. Difficile, Company's First Handheld MDx Test


Quidel said this week that it has received the CE mark for its AmpliVue C. difficile assay, making it the first commercially available test using Quidel's non-instrumented format.

The assay, which is now for sale in European countries recognizing the CE Mark, detects toxigenic Clostridium difficile bacterial DNA. It incorporates lateral flow technology licensed from Alere and isothermal helicase-dependent amplification technology licensed from BioHelix in a compact, handheld cassette.

In a research note published this week, Nicholas Jansen, an analyst for financial services firm Raymond James, noted that the new test is likely to immediately compete with Meridian Bioscience's Illumigene C. difficile molecular amplification assay, which is a similar lower-cost, isothermal amplification-based test; and later potentially compete with Cepheid's GeneXpert C. difficile assay.

However, Jansen noted, Quidel would first likely need to garner approval from the US Food and Drug Administration, which the company plans to seek this year. Both the Meridian and Cepheid tests have CE marking and are FDA approved.

"While we believe the European market remains underpenetrated for molecular [C. difficile], we would expect the bigger opportunity to remain [in the US] for the time being given some of the well-documented European headwinds and more modest commercial infrastructure in place overseas for Quidel," he noted.

"Given the initial US hospital targets for AmpliVue, we believe it could place incremental pressure on Meridian’s Illumigene C. diff growth (and the company’s non-molecular C. diff assays) first, relative to Cepheid’s GeneXpert system," Jansen added.

He also noted that he would expect Quidel management to price its assay competitively, in the range of $20 per test, versus more than $25 for Illumigene and more than $30 for GeneXpert, "which should help to drive market share over time, particularly at the low-end of the spectrum."

Quidel unveiled the AmpliVue product line in October during a conference call discussing the company's third-quarter 2011 earnings. At the time, President and CEO Douglas Bryant noted that the company had commenced manufacturing of clinical lots for AmpliVue tests for C. difficile and for methicillin-resistant Staphylococcus aureus, and that it planned to submit both tests for FDA approval in the first half of this year (PCR Insider, 10/27/2011).