Quanterix and BioMérieux recently announced a partnership giving BioMérieux worldwide exclusive rights to Quanterix's Single Molecule Array, or SiMoA, technology for clinical assay development and industrial applications.
According to the companies, Quanterix will provide BioMérieux with a SiMoA instrument, which it will use for multiplex assay development, primarily for infectious disease, but also for other assays such as a post-prostatectomy prostate specific antigen screening test. As part of the partnership, BioMérieux invested $15 million in Quanterix as part of a Series C financing round. The company said it raised $18.5 million in the round in total.
Quanterix's SiMoA technology is a sandwich immunoassay that allows multiplex digital detection of single molecules. The platform consists of arrays of femtoliter-sized reaction vessels, each sized to confine a single molecule of interest, allowing each well to function as an independent assay for a single molecule.
In 2011 the company announced a partnership with Sony DADC to manufacture Quanterix's single-molecule arrays on optical disc consumables (BAN 7/26/2011) and also announced a partnership with Stratec Biomedical to develop the automated analysis system for processing the company's single-molecule arrays (BAN 8/16/2011).
According to Julien Bradley, Quanterix's senior director of marketing, SiMoA's single-molecule approach allows a "thousand-fold improvement" in sensitivity over conventional ELISAs.
"This means existing assays can easily be adapted to [the platform] to obtain higher sensitivity, and that the cost of running assays using SiMoA is comparable to conventional immunoassay even though the sensitivity is similar to that achieved with nucleic acid testing," he told BioArray News in an email.
BioMérieux's senior communications director, Koren Wolman-Tardy, echoed Bradley in explaining the company's interest in SiMoA.
"Their technology is unique, offering high sensitivity, equivalent to molecular biology, but at a lower cost. The multiplexing will make it possible to simultaneously measure different analytes from the same specimen," she wrote in an email to BAN.
BioMérieux announced in 2011 that, while it would continue to use Affymetrix arrays for biomarker discovery, it was moving all of its array-based assays to other platforms (BAN 3/29/2011).
Wolman-Tardy said that BioMérieux has been a focused player in immunoassays, and is hoping to strengthen its position through the Quanterix partnership.
Using the SiMoA technology, the company will develop a menu of tests including "tests whose current medical value could be improved, such as the PSA test," to predict prostate cancer recurrence following prostatectomy, as well as use the platform to quantify biomarkers that are "currently difficult or impossible to measure," to create tests addressing as-yet unmet needs.
"We estimate that the menu could have around 20 different parameters, including tests in infectious diseases, which is our core expertise," Wolman-Tardy wrote.
According to Quanterix's Bradley, the firms' exclusive license means "other diagnostic companies will not be able to use the SiMoA technology to develop and commercialize assays."
The company still sees a market for research-use-only applications of its technology, however, and plans to commercialize its fully automated version of its SiMoA technology, called the SiMoA HD-1 Analyzer, for RUO use by the middle of next year.
According to Bradley, Quanterix expects pharmaceutical and biotech customers to be "one of the key segments that will be most interested" in the new automated platform for biomarker discovery for companion and other diagnostics.
"The analyzer will be fully automated so that users simply insert samples … load reagents, and select the assay they want to run from the touch-screen menu. All washing, mixing, and incubation steps are automated, as is the imaging and data output. This allows a user to set up the assay in a matter of minutes and truly walk away until the samples are done," he said.
Bradley said that companies exploring markers for companion diagnostics would fall under the RUO category. "[But] If they find that a marker can be measured using the SiMoA platform [and] has utility as a companion diagnostic, they would have to work with BioMérieux to develop the diagnostic component through BioMérieux," he said.
Companies Quanterix has partnered with for diagnostics research include Novartis, In-Q-Tel (BAN 1/10/2012), the Department of Homeland Security, and the Forsyth Institute at Beth Israel Deaconess Hospital, he added.