This article has been updated from a previous version to correct the spelling of Quidel's AmpliVue technology.
By Ben Butkus
Quidel executives said this week that the non-instrumented, handheld, molecular diagnostic platform it is developing with partner BioHelix will be called AmpliVue, and that it intends to begin clinical trials for the first two AmpliVue assays before the end of the year and submit them for US regulatory approval in the first quarter of 2012.
In addition, Quidel said that it recently restructured a licensing agreement with Alere for the lateral flow strip technology used in the AmpliVue platform; and provided analysts and investors with an update on its other molecular diagnostics initiatives: the Project Open Box agnostic qPCR diagnostic assays and Project Wildcat fully integrated benchtop molecular testing system.
In a conference call this week discussing Quidel's third-quarter financial results, President and CEO Douglas Bryant said that the company's molecular diagnostics efforts have "progressed considerably" in the third quarter, highlighted by the commencement of manufacturing of clinical lots for its first two AmpliVue assays for methicillin-resistant Staphylococcus aureus and Clostridium difficile.
The previously unnamed AmpliVue platform combines lateral flow detection technology with BioHelix's isothermal helicase-dependent amplification, or HDA, technology in a rapid, handheld format for point-of-care molecular testing.
Quidel and Beverly, Mass.-based BioHelix have been working together on the platform since 2009. BioHelix has also been independently developing POC molecular assays with its HDA technology, and last week said that it had won US Food and Drug Administration clearance for its first such test, the IsoAmp HSV assay for detecting herpes simplex virus in genital and oral lesion specimens from symptomatic patients (PCR Insider, 10/20/11).
During Quidel's conference call, Bryant noted that the BioHelix approval is construed as a positive from Quidel's perspective.
"This was an assay that predated our relationship actually … and the folks at BioHelix I think should be congratulated," Bryant said. "As I understand it they submitted the assay in July, so the turnaround with the FDA is encouraging and perhaps helpful to us … as we move forward with the assays that we have co-developed with them."
Bryant said that Quidel is manufacturing the clinical lots of its AmpliVue assays with the intent to start clinical trials in Q4, and the expectation "to be finished and to have that package submitted to the FDA in Q1."
During the call Bryant also drew attention to a recently restructured deal with Germany's Alere surrounding that company's lateral flow strip technology, which Quidel uses in the AmpliVue platform. According to September filings by both companies with the US Securities and Exchange Commission, Quidel agreed to make a one-time payment to Alere of $13.8 million in exchange for reducing the royalty rate payable under the license from 8.5 percent to 4.25 percent retroactive to July 1 of this year and ending with the expiration of the last patent in Alere's lateral flow patent portfolio.
In addition, in January 2012, at the option of either company, the remaining royalty obligation under the license may be converted to a fully paid license effective Jan. 1, 2012, in exchange for a one-time Quidel payment of $15.7 million less royalties paid at the reduced 4.25 percent rate between July 1 and Dec. 31 of this year.
Bryant said during the call that the restructured deal was "a matter of making sure that going forward we understood what our costs were, and I think that the deal itself is a good deal for [Alere]. And certainly it is a good deal for us relative to the [return on investment]."
On other molecular diagnostic fronts, Bryant highlighted during the call the fact that Quidel received the CE Mark for its first two assays under its Open Box initiative: tests for influenza A and B (PCR Insider, 8/10/11) and human metapneumovirus (PCR Insider, 9/22/11), both of which Life Technologies will be marketing in Europe for use on its Applied Biosystems-branded 7500 family of qPCR systems.
Project Open Box refers to Quidel's strategy of developing PCR-based molecular tests for infectious diseases for use on molecular diagnostic testing systems sold by other companies.
Bryant told analysts during the call that thus far, "performance data on the assays that [Life Tech] has chosen … is very, very good. These assays are very competitive and I would expect that Life will do quite well."
Bryant added that interest in the company's real-time PCR assays "goes well beyond [Life Tech's] interest in our flu and metapneumovirus assays … and obviously we are in discussions with other folks, depending on geographic location, who would also have equal interest in representing our kits on their platforms." The agreement between Quidel and Life Tech covers two additional assays on top of the influenza and metapneumovirus tests.
Lastly, Bryant said that the company is making progress with Project Wildcat, which describes a fully automated molecular testing system the company is developing in concert with researchers from Northwestern University and the NU Global Health Foundation.
"We are evaluating our molecular assays on the … device with multiple specimen types," Bryant said. "Development of the instrument is progressing and we continue working towards our goal of launching by the end of 2013."
Besides its molecular diagnostics initiatives, Quidel currently has two other major development programs underway. First, the company received the CE Mark this month for its Sofia Fluorescent Immunoassay Analyzer and Influenza A and B assay, the first test to run on the system. In addition, Quidel's Bobcat automated direct fluorescent assay analyzer just finished beta site trials in Hong Kong and New Zealand and will enter US clinical trials in the fourth quarter, the company said.
Quidel has not yet begun to garner significant revenues from its molecular diagnostics initiatives. For the third quarter ended Sept. 30, Quidel increased its revenues 17 percent to $33.1 million compared to $28.2 million in the same quarter last year, driven primarily by growth in its infectious disease product line.
Net loss for the third quarter of 2011 was $1.1 million, or $0.03 per share, compared to a net loss of $5.9 million, or $0.21 per share, for the third quarter of 2010.
As of Sept. 30 Quidel had cash and cash equivalents totaling $5.1 million.
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