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Quidel MDx Initiatives Move Ahead Led by Planned Q2 510(k) Submission for Isothermal C. Diff Assay

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Quidel President and CEO Doug Bryant said this week that the company expects to complete clinical trials by the end of the current quarter to support a subsequent application for US regulatory approval of its AmpliVue C. difficile assay, the company's first non-instrumented molecular diagnostic test.

In addition, Bryant said that Quidel has several additional AmpliVue assays in development, two of which it is "optimistic" will enter clinical trials in the second half of this year; and that the company is already planning a "next-generation" version of the platform.

Bryant discussed these items, as well as Quidel's progress on other molecular diagnostic fronts, during a conference call yesterday discussing the company's first-quarter 2012 financial results.

Quidel's first-quarter revenues fell 36 percent to $38 million from $59.6 million in the year-ago period, primarily due to a decrease in sales of its immuno-based flu diagnostic assays following a relatively inactive cold and flu season. The San Diego-based diagnostics company has been busy over the past two years diversifying its business to include molecular diagnostics, and just began selling its first MDx products in Q1, but did not disclose any meaningful revenues in its earnings release this week.

Nevertheless, Bryant updated investors on what is shaping up to be a busy year on the MDx front for Quidel.

First, Bryant noted that Quidel in Q1 received CE marking for the first assay in its AmpliVue product line, a test for Clostridium difficile that incorporates lateral flow technology from Alere and helicase-dependent amplification technology from BioHelix in a compact, handheld cassette (PCR Insider, 3/29/2012).

Bryant remarked that Quidel is "working through all the requisites for a European launch [of AmpliVue C. difficile] this May;" and that in the US, "clinical trials should be completed by the end of this quarter and we plan to submit a 510(k) package [to the US Food and Drug Administration] shortly thereafter."

Bryant noted that the company is "excited" about the technology, which will immediately compete with Meridian Bioscience's Illumigene C. diff assay, "because this format can easily be used in smaller hospitals and labs where molecular assays are not currently run, and as a complementary part of a larger hospital’s overall testing algorithm."

Bryant also told investors that the company is currently developing several additional AmpliVue assays, "two of which we’re optimistic could be in clinical trials in the back half of this year."

Later in the call, in response to an analyst's query, Bryant noted that one of the assays in development — but not necessarily one of the two expected to begin clinical testing this year — is for methicillin-resistant Staphylococcus aureus. He declined to identify the other infectious disease assay targets.

Bryant also said that the company already has plans for a next-generation version of the testing platform, which would "simplify the housing design and give it a better look and feel and perhaps some other ease-of-use factors."

Regarding another one of Quidel's molecular diagnostic initiatives — its portfolio of real-time PCR based assays for use on other companies' thermal cyclers — Bryant said that Quidel has begun US clinical trials for its molecular C. difficile and combination respiratory syncytial virus/human metapneumovirus assays, and that it plans to submit 510(k) packages for each "later this year." Quidel received CE marking for both assays in early April (PCR Insider 3/15/2012 and 4/5/2012).

"Seven other PCR assays are in various stages of development and I’ll elaborate more on the status of these assays in the future," Bryant said during the call.

Quidel also received FDA clearance in March for its Molecular Influenza A+B assay for use with the Cepheid SmartCycler PCR system after receiving similar clearance in December for the assay to be used on Life Technologies' ABI 7500 Fast Dx thermal cycler (PCR Insider, 3/22/2012).

Lastly, Quidel is making progress in its collaboration with the Northwestern University Global Health Foundation to develop a fully integrated benchtop molecular testing device. The collaboration, dubbed Project Wildcat, has made "significant strides with respect to the rights and patent claims on a novel extraction technology which marks the critical front end of the molecular testing process," Bryant said during the call.

The partners plan to initially launch HIV viral load and tuberculosis assays on the platform, and both assays require extraction of nucleic acid from either whole blood in the case of HIV, or sputum for TB, Bryant noted.

Northwestern, he added, has developed "a novel extraction methodology called Phase Gate that dramatically reduces extraction time by the elimination of conventional wash steps used by other extraction technologies."

The company has further developed the technology since then and filed a series of patent applications with the US Patent and Trademark Office. Bryant said it recently received a notice of allowance from the USPTO on its first set of applications and "[we] expect others to follow shortly."

Bryant also noted during the call that Quidel recently made a milestone payment of an undisclosed amount to the NUGHF in relation to the project; and he reiterated a commercialization timeline of 2014 or 2015.

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