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In Menarini Deal, Silicon Bio Sees Opportunities for Clinical Validation, Menu Expansion

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Silicon Biosystems believes that its recent acquisition by the Menarini Group, an Italian pharmaceutical company, will provide it with the support to move its cell array platform into the clinical market.

The Bologna, Italy-based firm also sees the Menarini deal as a means to grow, and as such plans to add sales and support personnel, as well as expand its R&D team, Bob Proulx, president of Silicon Bio's San Diego-based US subsidiary, told BioArray News.

The Menarini Group bought Silicon Bio earlier this month for an undisclosed sum to complement its internal R&D programs. As part of the deal, Silicon Bio will continue to operate as a standalone company.

Proulx said that Silicon Bio had been planning a financing round when the opportunity to be acquired by the Menarini Group came up, and that the company now has a strong parent organization with the resources to help it fulfill its objectives.

"We were going to have limited funds to do what we wanted to do through normal organic growth and now we have the support of Menarini and the initiative to go after markets for clinical utility," Proulx said.

Silicon Bio was founded in 1999 and, following years of prototyping, in 2010 launched its DEPArray microelectronic array-based platform. Using DEPArray, researchers can isolate, analyze, and manipulate cells, including rare cells such as stem cells and circulating tumor cells, in a suspension matrix.

According to Proulx, about 70 percent of Silicon Bio's existing customers use the platform for cancer biology work, while 15 percent use it in prenatal diagnostics, and another 15 percent use it for stem cell research.

Silicon Bio customers have published two papers this year that feature the technology. In April, a team from the Translational Cancer Research Unit at Sint-Augustinus Hospital in Antwerp, Belgium, highlighted the use of the platform to characterize tumor cells. In July, a group at the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori in Mendola, Italy, described how it used Silicon Bio's technology to isolate and characterize KRAS mutations in circulating colon cancer cells.

To broaden its appeal to such customers, the company would like to reconfigure the system so that it meets the standards of clinical researchers by achieving regulatory clearance in the US and Europe as a "Class II-like device." In the US, Class II devices are regulated by the US Food and Drug Administration, and are defined as moderate- to high-risk medical devices that require special controls such as special labeling to provide assurance of the device's effectiveness.

"The initial plan is to get analytical validity for the technology to be used in a clinical setting," said Proulx. "Ultimately, its intended use will be the recovery and analysis of CTCs that can answer questions in cancer biology."

Proulx said that Silicon Bio will also use its new resources to expand its organization to "give us more depth than we had before." About these planned hires, he said that "having appropriate field sales and support is critical" and that the firm would like to expand its R&D team in Bologna to work on application development.

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