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Quidel Says Respiratory Products Drive Q1 Growth; Provides Update on MDx Uptake

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Quidel said this week that increased flu testing and subsequent demand for its respiratory diagnostic tests — including its relatively new Quidel Molecular portfolio — helped drive a 63 percent year-over-year spike in first-quarter revenues.

In addition, Quidel President and CEO Doug Bryant said that the company expected two programs — the company's AmpliVue isothermal amplification-based molecular diagnostic products and Sofia fluorescent immunoassay products — to be most responsible for near-term growth at the firm.

Bryant touched upon these and other business items during a conference call this week discussing Quidel's first-quarter earnings.

Quidel, which until a few years ago primarily played in the immunoassay market, has more recently shaped a molecular diagnostics strategy, hallmarked by three main programs. The first and most mature of these initiatives is the Quidel Molecular program, which includes PCR-based assays for use on other companies' thermal cyclers — most notably Life Technologies' ABI 7500 Fast Dx and QuantStudio Dx systems.

In addition, Quidel recently launched AmpliVue, a handheld disposable testing platform that combines isothermal amplification with lateral flow detection. It also is developing the Savanna MDx system, previously named Project Wildcat, an automated sample-to-answer testing platform that the company expects to launch in Africa in 2014 with an HIV viral load assay and in other countries in 2015 with an extensive test menu.

Despite this push, the company still plays heavily in the immunoassay space, and these products, particularly the Sofia fluorescent immunoassay analyzer and related tests, continue to be the biggest growth driver at the company. In recent quarters, however, the company has begun realizing revenue from its molecular programs.

For the first quarter ended March 31, Quidel recorded revenues of $62.0 million, a 63 percent improvement from $38.0 million in Q1 2012. Although the company did not break out its revenues by type of test, Bryant noted that this increase was driven by the heavy flu season.

"As a result we experienced increased demand across the entire range of our respiratory test formats including QuickVue and Sofia, Quidel Molecular, and DFAs D3 Ultra," Bryant said. Respiratory disease assays in the Quidel Molecular portfolio include a test for Influenza A and B, and an assay for respiratory syncytial virus and human metapneumovirus.

During the call, in response to an analyst's question, Bryant noted that the most significant opportunity in the Quidel Molecular program centers on its partnership with Life Technologies — a company that has also recently built out its molecular diagnostic capabilities.

"The most significant opportunity we believe in the future would be access to the QuantStudio Dx, which is the new upgrade, if you will, to the 7500 Fast Dx," Bryant said. "We have exclusive rights … and access to certain IP that we thought was useful for developing quantitative PCR assays."

Furthermore, Bryant stated, "in terms of commercial opportunity, we think that there will be customers at some stage who will want to have some consolidation of menu onto a platform that could serve multiple purposes, and I think the QuantStudio [Dx] could be that analyzer."

Life Tech and Quidel in March received 510(k) approval from the US Food and Drug Administration to market the Quidel Molecular Direct C. difficile assay with the QuantStudio Dx and ABI 7500 Fast Dx. The assay had already received the CE mark in November. In addition, Quidel's influenza A+B test is FDA-cleared on both the 7500 Fast Dx and Cepheid's SmartCycler.

AmpliVue

Meantime, Bryant noted that in the first quarter Quidel received FDA clearance and CLIA moderate complexity designation for AmpliVue C. difficile — the first assay on the AmpliVue system.

"Three months or so into the launch we can say that customer receptivity to the handheld disposable molecular platform format has been good and assay performance in customers' hands is good and at least equivalent to the prominent molecular C. diff assays," Bryant said.

Bryant added that the company was "encouraged by what we see in the field so far and are now more confident that our investment in the development of additional AmpliVue assays for infectious disease targets … is warranted," he added. The company is also developing AmpliVue tests for herpes simplex virus, Bordetella pertussis, Group B Streptococcus, and trichomonas, among other targets.

In response to an analyst's question regarding the early uptake of AmpliVue C. diff, Bryant said that the company's initial view is that the greatest need for AmpliVue C. diff is with customers who are currently using either an enzyme immunosorbent assay only or a glutamate dehydrogenase assay followed by EIA.

"That certainly has been true for the most part," Bryant said. However, the company did not anticipate the amount of higher-volume customers that have committed to using "one or more … of the more prominent molecular methods," Bryant added, without elaborating.

The AmpiVue assay, he noted, "is easy to use … and doesn’t require an instrument, [which is] a major factor. It has somewhat of the cool factor; it's unique; and it's disposable. There clearly is … recognition in the marketplace [to move to molecular], and there are still a lot of customers that haven’t quite made the leap yet."

In general, Bryant said, early AmpliVue customers "are receptive to the format, like the data that we’re presenting, and some have signed two- to three-year purchase agreements. We’re ahead of our internal forecast in terms of the number of customers at this stage. So I would categorize it as so far, so good."

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