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Meridian Bioscience Pushes Its Way into MDx Space

By Tony Fong

NEW YORK (GenomeWeb News) – Meridian Bioscience, firmly established in the traditional in vitro diagnostics space, has jumped into the molecular diagnostics field with a new product launch and an acquisition.

In recent weeks, Meridian has received 510(k) clearance from the US Food and Drug Administration for its C. difficile test, and bought reagents firm Bioline for $23.3 million, thrusting the company into the molecular biology and molecular diagnostics space, where it hopes to take advantage of opportunities in higher value diagnostics, Rick Eberly, executive vice president for Meridian and president of its wholly owned subsidiary, Meridian Life Science, told GenomeWeb Daily News.

Founded in 1976, the Cincinnati, Ohio-based firm has mainly focused on the immunoassay market for diseases such as respiratory, gastrointestinal, viral, and parasitic infectious diseases. But the post-genomic age has resulted in new technologies and methods with applications in the MDx space, and like other companies, Meridian is looking to leverage the new sciences to new revenue streams.

Meridian's initial foray into the molecular diagnostics space is its illumigene C. difficile test, which the company launched last month at the American Association for Clinical Chemistry conference after it received FDA clearance. The test was developed on Meridian's illumipro-10 platform, which uses Loop-Mediated Isothermal Amplification, or LAMP, technology for the amplification of DNA. Meridian licensed the technology from Japanese firm Eiken Chemical in 2006.

The illumigene test and the illumipro-10 platform were initially launched in Europe in April.

In short, the LAMP technology uses special primers and a polymerase to produce DNA at higher amounts than can be achieved with PCR-based amplification. Pyrophosphates are released, resulting in visible turbidity due to precipitation. This turbidity can easily be seen with the naked eye, and the reactions can be followed by measuring either the turbidity or the DNA signals with fluorescent dyes.

Sequences of interest are amplified during the process, allowing for detection. In the case of C. difficile, this means the gene region in the bacterial pathogen that is responsible for the production of toxins in humans.

Other firms such as Cepheid, Becton Dickinson, and Gen-Probe also have molecular tests for C. difficile, but according to Eberly, Meridian's test has sensitivity rivaling any other test on the market and in development, and in addition, offers greater ease-of-use, and cost-savings.

"We're proud of the fact that illumigene is the first commercially available isothermal amplification technology that provides a very, very low cost instrumentation … but also a technology that's very, very simple to use," Eberly said.

In prepared remarks accompanying the release of Meridian's third-quarter earnings last month, CEO John Kraeutler said that "continuing competitive challenges in C. difficile testing" contributed to a drop in the company's core diagnostics business, but the "illumigene C. difficile is expected to help restore growth" in that market.

Meridian's goal is to now build off the launch of the test to develop additional tests using the illumipro-10 platform. Eberly declined to specify what indications the tests under development will address except to say they will be in the infectious disease areas.

"There's where our expertise lies both with immunoassays and now with our molecular technology," he said. He also declined to provide a timeframe for possible launches of new tests.

The other front by which Meridian is entering the molecular biology space is through acquisitions. The company's M&A strategy is a simple and familiar one — acquisitions should be complementary to the existing business and should be accretive and provide a quick return on the deal, Eberly said.

He wouldn't comment on what opportunities in the molecular biology space Meridian may be eyeing, but he suggested that any future deal could follow a similar strategy to the Bioline deal. Based in London, Bioline manufactures molecular reagents such as nucleotides, DNA polymerase enzymes, and other reagents used in PCR testing for DNA, RNA, and other genomic applications — products that Meridian did not have in its portfolio.

"One of the things that we saw in the life science business is that we really needed to be able to provide research reagents to our research customers," Eberly said. "And one of the highest-growth research areas right now is obviously molecular biology …so we saw this as adding … products and technologies to our research customers," he said.

Meridian will operate Bioline, which is anticipated to generate $12 million in revenues this year, as a wholly owned subsidiary, while keeping its name and retaining its president and founder, as well as the current leadership team, to run the firm.

As it moves into the molecular biology space, Meridian has no plans to shift away from its core traditional diagnostic business. Rather, the MDx business is a "new growth segment of our overall diagnostic business and life science business," Eberly said. Meridian sees the MDx space as a potential growth opportunity, but it also believes that there will be a "fairly high need" for immunoassays, especially for use for protein biomarker detection.

"New protein biomarkers will continue to require immunoassays to detect those proteins unlike needing a molecular test to detect DNA or RNA," Eberly said, adding that the company continues to invest in new products in the immunoassay space.

During its fiscal third quarter, the most recently completed quarter, Meridian said it had sales of $33.9 million, down 11 percent from a year ago, with its US and European diagnostics business recording $27.3 million in sales, down from $31.8 million in the year-ago period. The life science business posted sales of $6.5 million up slightly from just under that amount the year before.

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