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Quidel Submits First Test for FDA Approval, CE Marking as MDx Strategy Takes Shape


By Ben Butkus

Quidel recently submitted a 510(k) package to the US Food and Drug Administration for its first molecular diagnostic assay, a real-time PCR-based test for influenza A and B for use on Life Technologies' 7500 Fast Dx platform, president and CEO Doug Bryant said this week.

In addition, Bryant said that the company has submitted an application to European Union regulatory authorities to obtain CE Marking for the same test; and that it is preparing to beta test the first two molecular assays designed for use on the non-instrumented testing platform it has been developing with BioHelix.

Bryant made his remarks during a conference call this week discussing Quidel's second-quarter earnings, as part of an update to investors on the immunoassay specialist's foray into the molecular diagnostics market, which also includes a fully automated, sample-to-answer molecular testing platform being developed in collaboration with Northwest University.

"Our molecular program is very much on track," Bryant said during the call. "And we’re very excited about the progress we’ve made to date."


San Diego-based Quidel has been shaping its molecular diagnostics strategy since at least 2009, when it signed an agreement with Beverly, Mass.-based BioHelix to jointly develop and commercialize in vitro molecular diagnostic tests for infectious pathogens in a non-instrumented, disposable platform that combines lateral flow detection technology with BioHelix's isothermal amplification chemistry.

Bryant said this week that Quidel is preparing to beta test the first two assays – for methicillin-resistant Staphylococcus aureus and Clostridium difficile – on the BioHelix platform, and that the company plans to begin clinical trials for the tests in the fall.

"We are working toward a US launch in the first half of 2012 depending on the timing of regulatory clearance from the FDA," Bryant said.

In addition, Bryant told investors during a Q&A session that the company is currently planning to pursue a direct sales strategy to market these assays, once approved; and that it would likely be able to dedicate more than two dozen salespeople to the task.

"Our total commercial organization at the moment in the US is about 60," Bryant said. "So we certainly think we can handle that within our existing resources without adds, but rather redeployment."

Quidel will be marketing the BioHelix tests particularly to smaller labs and segments of the healthcare system where molecular diagnostic tests have not traditionally been performed, but may be beneficial.

"Instead of making a large upfront capital investment, any lab can run these assays using only a low-cost heating block," Bryant said.

Open Box

Concurrent to commercializing the BioHelix tests, Quidel will be striving to meet internal goals related to the second facet of its molecular diagnostics strategy: the Open Box project, which describes the company's efforts to develop molecular testing kits for infectious diseases for use on existing molecular testing platforms.

Bryant said during the conference call that Quidel recently submitted a 510(k) package to FDA seeking clearance to market what would be its first molecular diagnostic assay, a real-time PCR test for influenza A and B for use on Life Tech's 7500 Fast Dx.

"We'll submit a similar package for use of the assay on Cepheid's SmartCycler very shortly," Bryant said. "In addition, we've submitted a package to European regulatory authorities for CE Marking, and expect to launch there in the fall."

Bryant also said that the company anticipates "significant menu expansion and product launches in the very near term" for Open Box.

When asked by an investor for more details on the company's pipeline in this area, Bryant said that the influenza test would be "followed very shortly … by a human metapneumovirus product and [respiratory syncytial virus] product," assays that the company is also considering combining into one test.

Bryant also said the company is preparing to launch tests for herpes simplex virus and varicella-zoster virus, as well as C. difficile, before the end of the year.

The rationale behind Open Box, Bryant said, is that by developing assays for use on commercially available thermocyclers, Quidel will "provide value by offering laboratory technicians significant improvements over existing assays with respect to process time, ease of use, storage, and cost."


Lastly, Bryant updated investors on the progress of Project Wildcat, an integrated, low-cost molecular platform that will perform extraction, amplification, and detection. Quidel is developing the system with scientists from Northwestern University and the Northwestern Global Health Foundation (PCR Insider, 4/14/11).

The sample preparation component of the platform will be based on immiscible phase filtration technology. The company has not yet disclosed the nature of the amplification and detection components of the instrument.

Bryant said this week that the company expects to complete its first development phase for the platform by the end of this year, and is on track for a late 2013 product launch outside the US.

Bryant also noted that the new system will have the ability to run the Open Box menu of molecular diagnostic assays.

"Our intent is to build a broader based diagnostic company that is uniquely positioned to meet the needs of laboratory customers regardless of location from rapid point of care; immunoassays to cell-based assays; to molecular diagnostics, each of which serves an important function in the diagnostic continuum. And as a result of our progress in the second quarter, we’re well on our way."

The company disclosed that it also submitted a 510(k) application to the FDA for its next-generation immunoassay instrument during the second quarter.

For the quarter ended June 30, Quidel increased its total revenues 10 percent to $27.5 million from $25 million in Q2 2010.

Meantime, the company logged a net loss of $3.7 million, or $0.11 per share, for the quarter; compared to a net loss of $2.5 million, or $0.09 per share, in the same period last year.

Have topics you'd like to see covered in PCR insider? Contact the editor at bbutkus [at] genomeweb [.] com.