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Singulex Partners with Tecan to Commercialize Multiplex IVD Immunoassay System by 2016

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Singulex this week announced that it has partnered with Tecan to deliver a biomarker detection platform to the clinical market within the next few years.

Singulex said that the envisioned system, dubbed Sgx Clarity, will pair its single molecule counting technology with Tecan's EVO liquid handling platform. By combining these technologies and tools, Singulex aims to have a CE-IVD marked assay for cardiovascular disease available for clinical use in Europe by 2016, with an intended submission to the US Food and Drug Administration the following year, CEO Guido Baechler told BioArray News.

Baechler said that Alameda, Calif.-based Singulex is looking to penetrate the diagnostics market with the new testing platform, noting that by partnering with Tecan, rather than developing additional liquid handling and optics capabilities in house, the company was able to quicken its time to market.

"We have a lot of Tecan systems in our clinical lab," noted Baechler. "It's an innovative company and a perfect match culture wise and technology wise."

Singulex's approach relies on microparticle-based immunoassays. During capture and detection steps, antibodies translate each biomarker into a signal. Fluorescent dye-labeled detection antibodies are subsequently released from the immune complexes and separated magnetically from the paramagnetic microparticles. And these detection antibodies are the source of signal during single molecule counting, according to the firm.

While its approach bears some comparison to multiplex bead array-based approaches, notably those marketed by Luminex and Meso Scale Discovery, Baechler touted the sensitivity of Singulex's approach, noting it was "two to three logs more sensitive" than Luminex or MSD. But the company also targets fewer numbers of biomarkers than those higher-throughput platforms, which separates it from rival multiplexing companies.

Singulex already offers its technology via an in-house developed platform called Erenna. However, Erenna is solely for research purposes, and the company has been making its single molecule counting approach available through its own CLIA-compliant clinical laboratory. The deal with Tecan, therefore, is Singulex's attempt to decentralize its platform.

"Now we will be able to globalize the technology," said Baechler. "We decided to partner with Tecan to provide a state-of-the-art immunoanalyzer that we can provide to hospitals reference labs around the world."

Gary Kuroki, Singulex's marketing manager, told BioArray News that while the firm's initial entries into the molecular diagnostics market will focus on heart failure and cardiovascular disease, the company's technology is "agnostic to disease states."

He added that the company's pipeline of tests will likely expand in time as "there are certainly numerous disease states that we'll be exploring."

Neither Kuroki nor Baechler would provide pricing for the planned Clarity system. Baechler expressed hope that the sensitivity of the company's technology, paired with Tecan's expertise, would provide a "clear new standard in immunodiagnostics."

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