Quidel's molecular diagnostic development programs are running ahead of schedule, with the first assays from the initiative expected to be available outside the US in the fall, company officials said recently.
In a conference call to discuss Quidel's first-quarter financial results, Doug Bryant, president and CEO, shed additional light on the company's molecular diagnostic initiative.
The company, which has to date played primarily in the immunoassay market, is taking a "three-pronged approach" to molecular diagnostics, Bryant said. This strategy includes a handheld assay platform it is developing in collaboration with BioHelix; "Project Open Box," which comprises PCR kits for use on other vendors' thermal cyclers; and "Project Wildcat," an integrated sample-to-result molecular diagnostic platform it is developing in collaboration with scientists from Northwestern University and the Northwestern Global Health Foundation (PCR Insider 4/14/2011).
Bryant noted that the company believes the total addressable US market for the handheld system and the Open Box assays is about $160 million. The addition of Wildcat, he said, "expands the total addressable market to about $760 million."
The Open Box program is farthest along. The company expects to complete clinical trials for its first two assays — one for influenza A and B and another for respiratory syncytial virus and metapneumovirus — "soon," and expects to launch the tests outside the US this fall.
"Depending on the timing of US [Food and Drug Administration] clearance, we could launch here in the US as early as the end of the year," he said.
Bryant added that the company has recently "improved the workflow of these assays to reduce the number of steps in the process and the amount of time needed to run them on commercially available thermal cyclers."
Regarding the non-instrumented tests that it is developing with BioHelix, Bryant said that the first two assays — for Clostridium difficile and methicillin-resistant Staphylococcus aureus — are "nearing clinical trials."
If the company gets a favorable response from the FDA, "we expect to launch in the US as early as the end of the year," he said. He added that a paper that demonstrates the clinical performance of the assays and platform is "forthcoming."
Quidel has been working with BioHelix on the handheld platform since 2009. The system is based on BioHelix's isothermal helicase-dependent amplification technology.
Bryant said that the company is targeting the platform at "larger hospital laboratories for use on their second and third shifts, as well as to smaller hospitals that have previously not performed molecular testing for reasons related to either cost, volume, or ease of use."
He noted that the assays do not require a thermal cycler or an extraction step. "The only piece of equipment required is a heating block that is already commonly available in most labs."
In addition to C. difficile and MRSA, the partners are developing tests for a range of infectious diseases, including group B Streptococcus, meningitis, tuberculosis, and vancomycin-resistant Enterococci.
The Wildcat project, which the company disclosed for the first time in October, is slated for a 2014 launch.
The platform is being developed to perform extraction, amplification, and detection in a single instrument and is intended for use in developing countries with initial applications in point-of-care HIV testing.
"Our belief is that when we develop such a product that is inexpensive and easy enough to use to address these markets, this type of product could be a game changer in the highly developed markets," Bryant said in the Q1 conference call.
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