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Italy's Silicon Biosystems Opens US Office to Sell DEPArray Cell-Analysis Platform

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By Justin Petrone

Italian biochip firm Silicon Biosystems has established an office in San Diego from which it hopes eventually to market its DEPArray cell-analysis platform into US clinics.

Robert Proulx, general manager of the firm's newly founded US subsidiary, Silicon Biosystems Inc., said that the US division envisions a clinical future for the DEPArray platform. "Our goal is to move from using the technology as a research tool to identify biomarkers to the point where we can use the system in clinical laboratories to help as an aid in diagnosis and treatment," he told BioArray News this week.

"We believe there will be opportunity to partner with [US] pharmaceutical companies for companion diagnostics as our technology helps pave the way to understand how a patient responds to specific treatments," he added.

Proulx said that expanding into the US was necessary because the country "is, and will continue to be, the largest single market" for Silicon Bio's cell-analysis platform, and the firm believes that being an early entrant in the US market will "give it a leadership position" as the market matures.

Silicon Biosystems was founded in Bologna in 1999 to market the DEPArray technology, which was developed by current Chief Technology Officer Nicolò Manaresi and Chief Scientific Officer Gianni Medoro.

The technology relies on dielectrophoresis, or DEP, to isolate and manipulate cells in a suspension matrix, which offers users the ability to control cells and microparticles inside a disposable cartridge.

Silicon Bio's cell microarrays consist of a microelectronic-active silicon substrate containing control circuitry for addressing each individual dielectrophoretic cage. According to the firm, DEP cage sizes can be set to accommodate one single cell, enabling the individual to manipulate a large number of cells per array.

Silicon Bio claims that cells in the DEPArray maintain their viability as their DNA is intact and their proliferation capability is unmodified. The company believes its platform can be used in applications such as prenatal and cancer diagnosis, cell therapy, and single-cell resolution biology.

The firm advertises the main application areas for the platform as cell sorting, cell-cell interaction, single-cell immunophenotyping, and drug delivery. Proulx said that while the technology "can be used for any rare cell application," the US office will focus most of its attention on the circulating tumor cell and stem-cell areas.

He noted that Johnson & Johnson's Veridex unit has received 510(k) clearance from the US Food and Drug Administration for its CellSearch Circulating Tumor Cell Test, which enumerates CTCs in order to predict risk for metastatic breast, colorectal, and prostate cancers.

"This has opened the field to be interested in learning more about the molecular character of CTCs," Proulx said. "For example, are the CTCs genetically similar to the solid tumor? If not, what might that indicate for changes in treatment or response to treatment for the patient?

"So our initial market penetration activities will focus on laboratories interested in molecular characterization of rare cells, like CTCs, to identify biomarkers," he said.

Asked about rival offerings, Proulx said there are "some newer technologies working on separation methods, like microposts and filtration methods, but they are not commercially viable solutions for the laboratory today."

Becton Dickinson offers fluorescence-activated cell sorting, or FACS, by flow cytometry, but Proulx said that FACS "lacks the ability to delivery purity of cells." DEPArray is a "finished product that is ready for market use that can deliver cells for molecular characterization or culturing because they system is non-contact and gentle on the cells."

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Beginning 'Commercial Discussions'

Silicon Bio CEO Giuseppe Giorgini said in a statement this week that a US presence will enable the firm to "begin commercial discussions with thought leaders" and "allow clinicians and researchers working to advance personalized medicine in areas such as clinical oncology to identify new biomarkers and improve patient treatment based on genetic information they have previously not had access to."

Proulx said the company set up the San Diego office to have "direct contact with and benefit from end-users."

The US operation will initially focus on commercial activities. "Our job will be to identify key opinion leaders and leading researchers working in areas of single-cell analysis that could benefit from the DEPArray platform to sell our first systems and gain a foothold in the nascent, but fast-moving market," Proulx said. The San Diego office will be "undertaking marketing, sales, and business development efforts to build the company’s market presence in the US and establish ourselves as a leader in the field."

At the moment, though, all of the San Diego office's activities are new. Proulx joined Silicon Bio this month. Between June and January he was acting vice president of marketing and business development at Trovagene, and vice president of marketing and sales at Nanogen from 2004 to 2009.

According to Proulx, Silicon Bio's board approved the creation of a US subsidiary in September, and since then the firm has "incorporated and created the necessary infrastructure to begin commercial activities."

Initially, the new office will "be acting in a marketing and sales agency capacity," he said, adding that Silicon Bio will add sales and support staff as demand for the product and opportunity grow.

"Our goal is to move the technology from research use to diagnostic use, and with that we will add resources and capabilities necessary to support marketing products compliant with regulations and the FDA," Proulx said.


Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com.

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