SV Bio emerges from stealth mode with genomic sequencing Dx advance

SV Bio is emerging from stealth mode. And CLIA certification is imminent for the California company's computer diagnostic system that enables easy use of genetic sequencing to screen for a variety of diseases.

What that means is that the California company known formally as Silicon Valley Biosystems is on the verge of selling its diagnostics platform. This is a major milestone for SV Bio and its backer--Sequoia Capital--a major VC firm that helped launch a number of other biotechs companies such as Apple ($APPL), Google ($GOOG) and Oracle ($ORCL)--names that are more than ubiquitous these days. Founder and CEO Dietrich Stephan explained to FierceMedicalDevices that the overarching goal now is to bring genomic sequencing for diagnosis of illness to the masses, after mixed attempts by others over the last decade to do so.

"We [the industry] have been doing research in genomics for a decade-plus," Stephan told us. "There is rhetoric as to why this hasn't penetrated the clinic yet. We believe it is very complex information. Our goal is to democratize this information to make it easy for physicians to understand so it becomes pervasive, and so patients can benefit. It is the fault of diagnostics companies that they haven't made it easy enough, so we're going to fix that."

CEO Dietrich Stephan--courtesy of SV Bio

The company's SV Bio platform is designed to take an initial blood test and then perform DNA sequencing within a few weeks. Then its software-based diagnostic can profile dozens of diseases within a matter of minutes, with clinical grade sensitivity and specificity as afar as what genetic variations in a patient's DNA sequence are a factor for a given disease or condition.

Stephan noted that the key assumption is that within a decade, everyone will have their genome presequenced and archived in their electronic medical record. That would leave his company's elaborate computer system to be called on to formulate diagnostics based on that record many times in the future.

"The platform will provide any type of genetic test for any type of human disease," Stephan said.

Right now, the company is finishing beta testing at a number of hospitals and with physician groups, and then sales will begin this quarter, once CLIA certification is wrapped up. SV Bio's 20 employees plan to build their own sales channel to physicians directly, focusing on sales through word-of-mouth, but also through potential partnerships with diagnostics or drug companies. Stephan won't disclose how much venture capital the company has raised since its initial launch in September 2011, other than to say SV Bio is "capitalized in the $10-million-plus range" and that they are on their second round of funding. Stephan explains that he'd rather focus on the company's technology rather than financials, though he notes that Sequoia's backing is significant.

"They are recognized as one of the premier VC firms in the industry," he said. "And they only invest in companies that can become independent, billion-dollar, market cap companies. And once they are in, they are in."

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