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BioMerieux Takes $15M Stake in Quanterix, Gains Exclusive Global License to SiMoA as IVD Platform

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With its recent investment in Quanterix, French diagnostics firm BioMérieux has added that company's Single Molecule Array high-sensitivity immunoassay platform to its offerings and positioned itself to take advantage of not only its own internal research on the platform but outside test development work as well.

This month BioMérieux took a $15 million equity stake in Quanterix as part of the company's $18.5 million Series C financing round. Under the terms of the agreement, BioMérieux received worldwide exclusive rights to the SiMoA technology in clinical labs and for industrial applications.

Quanterix will produce for BioMérieux a version of the SiMoA device suitable for in vitro diagnostic use on which BioMérieux will develop and commercialize clinical assays. Quanterix will receive upfront and milestone payments along with royalties on future sales.

Separate from the BioMérieux deal, Quanterix is also developing a research-use-only version of the device that it plans to launch in the summer of next year, according to Julien Bradley, Quanterix's senior director of marketing.

BioMérieux's license to the IVD version of the SiMoA platform means that researchers or firms seeking to bring to market as IVDs protein markers identified on the RUO device will have to take those commercialization efforts through BioMérieux, Bradley noted.

"They are the only ones allowed to use the SiMoA platform [for IVDs]," he told ProteoMonitor. "Anyone who discovers some valuable new marker [on the SiMoA platform] will have to go through BioMérieux to turn it into an actual diagnostic kit."

"Typically a lot of this [biomarker] research is done in academic settings where they would need a commercial partner [like BioMérieux] anyway," Bradley said, adding that pharma firms, too, often seek outside partners to develop commercial companion diagnostic assays.

From Quanterix's perspective, the deal allows the company to access the IVD market without directly taking on the challenge of the diagnostics regulatory process, Bradley noted. "There is obviously a very significant investment required to get diagnostic tests approved, to get them through clinical trials and commercialized in the IVD space," he said.

Under the agreement, he noted, "BioMérieux will be responsible for all regulatory requirements pertaining to getting approved tests onto the market. It allows us to tap into the potential of [the IVD] market without making a huge investment to get there."

In a 2011 interview, Quanterix's then-CEO David Okrongly told ProteoMonitor that concerns about the regulatory challenges facing IVDs and the US Food and Drug Administration's evolving views on laboratory-developed tests had contributed to the shift from its original focus on protein diagnostics development to building and selling the SiMoA platform itself (PM 2/25/2011).

Okrongly at that time said that instead of focusing on building tests internally the company aimed to drive SiMoA test development by selling an RUO version of the device to scientists and pharma companies that would use it to develop diagnostics and generate content for the IVD-approved platform.

This essentially remains the plan under the recent deal, with the difference being that instead of licensing the tests directly itself, Quanterix will receive royalties on tests sold through BioMérieux.

Key to this strategy, of course, is achieving uptake of the RUO device by academic researchers and biotech and pharma firms. Bradley said that upon launch of the RUO platform next year Quanterix plans to release a menu of 30 to 50 research assays covering areas including neurology, oncology, cardiology, and inflammatory and infectious diseases. He said it will also release a "homebrew kit that will allow researchers who already have their own antibodies to build their own assays."

Quanterix already has several collaborations in place around the SiMoA platform. The company has worked with academic groups at New York University School of Medicine (PM 6/11/2010) and the University of Gothenberg (PM 4/15/2011) on, respectively, assays for prostate specific antigen and potential Alzheimer's biomarkers.

Last year it signed a technology-evaluation agreement with Novartis Diagnostics under which Novartis was to use the technology to measure an undisclosed neuronal protein.

And, in January, it received an investment of an undisclosed amount from In-Q-Tel, a non-profit investment firm that delivers technology to the US intelligence community, to develop the SiMoA technology to detect pathogens via measurements of proteins and nucleic acids (PM 12/6/2012).

In-Q-Tel was also a participant in Quanterix's recently closed Series C round, joined by existing investors ARCH Venture Partners, Bain Capital Ventures, and Flagship Ventures.

In a release announcing its investment in Quanterix, BioMérieux noted that its internal test development work using the SiMoA platform will have "a particular focus on infectious diseases."

Although its test development efforts initially focused primarily on PSA and Alzheimer's markers, Quanterix has in recent years gained a foothold in the infectious disease space. In addition to the In-Q-Tel pathogen detection deal, the company received in 2011 a $200,000 grant from the US Department of Homeland Security to develop an assay to detect botulism toxin.

Last month the company published a study in the Journal of Virological Methods demonstrating use of the SiMoA single-molecule immunoassay system for detecting HIV infection (PM 10/12/2012).

According to the company, the SiMoA platform was able to detect HIV with more than 3,000 times greater analytical sensitivity than conventional immunoassays and at a level comparable to the current gold standard, nucleic acid testing.

In an email to ProteoMonitor, Koren Wolman-Tardy, BioMérieux's senior communications director, noted that the company expected the platform's high sensitivity would pave the way to new applications addressing unmet needs in in vitro diagnostics. In addition to infectious disease work, she cited measurement of PSA to predict prostate cancer recurrence following a prostatectomy as another potential application.

She declined to provide a timeline for the company's commercial launch of the IVD system or details of what diseases it might target first, but noted that the test menu could have "around 20 different parameters."

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