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Quidel Reports 2 Percent Uptick in Q3 Revenues; Acquires MDx Firm AnDiaTec

This article has been updated from a previous version to include comments from Quidel's Q3 earnings call.

NEW YORK (GenomeWeb News) — Quidel reported after the close of the market on Wednesday that its third quarter revenues inched up nearly 2 percent year over year as sales of flu products increased but were offset by flagging sales of Strep A and pregnancy lateral flow tests.

Quidel also reported that during the quarter it completed the acquisition of AnDiaTec, a German molecular diagnostics company, for approximately $2.6 million upfront and a three-year, $4.7 million R&D earn-out.

For the three months ended Sept. 30, Quidel's revenues rose to $33.5 million from $33 million in the year-ago period. While the company noted the impact of its immunoassay-based flu, Strep A, and pregnancy products, it did not break out revenues for its comparatively fledgling molecular diagnostics business.

The company continues to build out this business, noting that in Q3 it received 510(k) clearance from the US Food and Drug Administration for the Quidel Molecular Influenza A+B and RSV+hMPV assays, both for use on Life Technologies' QuantStudio Dx Real-Time PCR system.

Quidel and Life Tech have an ongoing agreement to develop and commercialize real-time PCR assays for the QuantStudio Dx. Also, under a previously signed agreement, Life Tech is marketing some of Quidel's PCR-based assays for use on the ABI 7500 Fast Dx Real-Time PCR system in Europe.

Quidel also sells a line of handheld lateral flow- and isothermal amplification-based diagnostics under the brand name AmpliVue. Currently the only such test available in the US and Europe is for Clostridium difficile. But the company is also developing AmpliVue tests for a number of other targets, and its efforts in this area were bolstered by the acquisition in May of BioHelix, whose helicase-dependent amplification technology Quidel had been using in its AmpliVue tests.

"The acquisition of BioHelix has greatly accelerated product development and we expect to launch more assays over the next couple of quarters and believe that the additional assays will create a collateral benefit in top-line acceleration," Quidel President and CEO Douglas Bryant said during a conference call discussing the Q3 earnings. "We are wrapping up clinical trials for two additional products and expect to submit packages to the FDA imminently. Behind that, two other assays will follow shortly."

Bryant added that "longer term, but equally important, particularly beyond 2015, is the development of Savanna, a robust fully integrated cartridge-based platform that will perform both real-time PCR assays as well as helicase-dependent amplification assays developed by the BioHelix team."

However, as in the most recent quarter, Quidel's immunoassay products — QuickVue, RapidVue, and Sofia — are expected to be the main revenue drivers in the near term.

"The Sofia assay is responsible for most of the incremental sales modeled for 2015," Bryant said. "Influenza A+B, RSV, group A Strep, and hCG have been developed and FDA cleared and Sofia Influenza is CLIA waved. CLIA waiver on the last three is important, as well, and we continue to make progress towards the goal of CLIA wavier on all Sofia products."

The acquisition of AnDiaTec, though, is expected to broaden Quidel's molecular expertise and further accelerate its molecular assay development.

Founded in 2003, AnDiaTec sells in vitro diagnostics based on real-time PCR, conventional PCR, and antibody-antigen detection for human, veterinary, food safety, and environmental applications, according to the company's website.

Quidel posted a net loss of $4.4 million, or $.13 per share, for the quarter, compared to a net loss of $676,000, or $.02 per share, in the year-ago period. On an adjusted basis, its loss was $600,000, or $.02 per share, compared to net income of $2.6 million, or $.08 per diluted share, in Q3 2012.

The firm's R&D spending increased 47 percent to $7.5 million from $5.1 million, while its SG&A expenses climbed 16 percent to $14.5 million from $12.5 million.

Quidel finished the quarter with $10.2 million in cash and cash equivalents.