Quidel this week provided an update on its budding molecular diagnostics business, noting that it saw "significant progress" in each of its three MDx initiatives.
Although Quidel has yet to log significant revenues from any of its molecular diagnostic products — it only recently received CE Marking and US Food and Drug Administration for its first two molecular assays — the company is on track to have its full complement of molecular testing products in place by the end of 2013, President and CEO Doug Bryant said during a conference call recapping Quidel's Q4 and full-year 2011 earnings.
The first prong of Quidel's molecular strategy, its real-time PCR assays for use on commercially available thermal cyclers, is the farthest along of its three molecular initiatives. Quidel's first two products in this niche are its human metapneumovirus assay and influenza A+B assay, both of which were CE Marked in the fall and received FDA clearance in December (PCR Insider, 1/5/12), and both of which Life Technologies markets in Europe for use on its ABI 7500 family of qPCR systems.
In response to an analyst's query about the uptake of these assays, Bryant noted that Quidel is "at the stage where a handful of customers are evaluating the product. And in Europe, to be more specific, there are 18 customers currently evaluating our PCR kits."
Bryant said he expected those tests to be "more [like] a base hit," continuing a baseball analogy from the analyst's question. "Certainly, as we introduce both in Europe and [the US] the hospital-acquired infection tests, notably [first] C. difficile, I think that actually is probably more than a base hit for us."
Bryant also said that Quidel is in the process of developing its test menu in this area, and that it expects its next assays — for Clostridium difficile and respiratory syncytial virus — to enter clinical trials by the end the current quarter. Bryant also noted that Quidel "recently submitted an additional assay to the FDA for 510(k) clearance," though he didn't specify the diagnostic target; and said that the company has seven additional real-time PCR assays in development.
Next up for Quidel on the molecular diagnostic front will be its AmpliVue handheld, disposable, point-of-care platform. This platform combines lateral flow detection technology licensed from Alere with isothermal helicase-dependent amplification technology from BioHelix.
In the company's Q3 earnings call in October, Bryant said that Quidel expected to begin clinical trials for the first two AmpliVue assays before the end of 2011 (PCR Insider, 10/27/11). In this week's call Bryant noted that in the fourth quarter Quidel initiated clinical trials for a C. difficile test on AmpliVue, and that it expects to submit a 510(k) package for the test to the FDA in the second quarter.
"Further, we expect to enter into clinical trials for two other AmpliVue assays over the next couple of quarters and I'll talk more about those products later in the year as we get closer to the launch," Bryant said.
Bryant also noted that AmpliVue represented a product line for which Quidel cleared some significant technological hurdles in the past year, allowing it to inch closer to market. Specifically, he said that Quidel scientists have upgraded the lateral flow strip technology such that "we might actually develop a universal strip that would be applicable to any assay, so that the cartridge itself would be universal … instead of developing a new strip for every single different assay.
"That challenge took us [more than] 12 months to overcome," he added. "Now that we've solved that, we don't need to do that again. In other words, that particular aspect of the product design is incorporated in all the products that we'll have moving forward for AmpliVue."
Another analyst asked about the potential customers for the AmpliVue product and the sales pitch that Quidel was preparing for those customers. Bryant noted that the AmpliVue assays are expected to be accurate, easy to perform, inexpensive, and to require no instrumentation.
"There are people who would say that the field for this type of products is crowded at this stage," Bryant said. "To those folks, I would say that the field for a handheld, disposable, non-instrumented device isn't crowded, because as far as I know, AmpliVue is the first of its kind. And there are many labs that don't do molecular testing. I think the main target for this device is folks that don't do molecular testing today."
Finally, Quidel's third molecular diagnostics initiative is Project Wildcat, a fully automated, PCR-based testing system that the company is developing in collaboration with researchers from Northwestern University and the NU Global Health Foundation.
"We continue to see steady progress with respect to Project Wildcat," Bryant said. "We're working on the next phase of instrument development and are advancing at a healthy expected rate."
As a result, Quidel may soon hit its next milestone payment to Northwestern, Bryant said, although he didn't specify when this might occur. "We continue working toward our goal of completing the development of Wildcat by the end of 2013," he said.