June 1, 2013 (Vol. 33, No. 11)

Cynvenio Biosystems Seeks to Differentiate Itself with Automated LiquidBiopsy Platform

Scientists have long recognized the potential of circulating tumor cells (CTCs) as diagnostic and prognostic indicators. Recent research has shown CTCs derived from whole blood can even have therapeutic implications, directing oncologists to choose tumor-specific treatments. But these cells are extremely rare, making detection and isolation a challenge.

Several companies have sprung up in the last few years seeking to harness the power of CTCs for personalized medicine. Cynvenio Biosystems is one such firm.

“We have a blood-to-readout solution,” says Cynvenio CSO Paul Dempsey, Ph.D. “The core technology relies on our ability to partition tumor cells from blood sufficiently so that we can directly analyze for mutations.”

The company’s LiquidBiopsy® platform is an automated rare cell isolation instrument designed to recover CTCs from whole blood samples with the specificity required to support downstream molecular analyses. Beyond CTC isolation, the instrument also performs nontarget cell removal and immunofluorescent staining.

Cynvenio’s LiquidBiopsy lab services include CTC isolation and enumeration (cells are returned to the customer for in-house analysis), PCR analysis (using Applied Biosystems’ Competitive Allele-Specific TaqMan® PCR), next-gen sequencing (using Ion Torrent’s AmpliSeq™ panel) and custom solutions (including protein-expression analysis). Cynvenio’s California lab was awarded CLIA certification by the state in May. André de Fusco, CEO, says the facility can handle up to 15,000 samples per year.

Moving beyond simply isolating and enumerating CTCs and into delivering custom molecular characterization is what de Fusco says sets his firm apart. “We are, I think, one of the only viable players in circulating tumor cells today,” he says.

Overall, Dr. Dempsey adds, “We have a system that’s able to go from a 7.5 mL blood draw to point mutations in fewer than 10 cells in a couple of days.”

Researcher using the LiquidBiopsy® platform, an automated rare cell isolation instrument designed to recover CTCs from whole blood samples for downstream molecular analysis.

Academic Beginnings

Like many biotech startups, Cynvenio was borne of technology developed in academia. Launched in 2007, the company was initially based on rare cell isolation technology developed by Hyongsok (Tom) Soh, Ph.D., and his colleagues at the University of California, Santa Barbara (UCSB).

Frederick Gluck, former managing partner at McKinsey & Company, provided initial seed capital. Though it has had some VC investments, Cynvenio remains a primarily angel-funded company. The firm has also been supported by funds from the NCI through a handful of SBIR grants.

De Fusco says it was a key contract with UCSB’s Institute for Collaborative Biotechnologies that got the company off the ground. Cynvenio later entered a development contract with an undisclosed large pharmaceutical firm.

Compared with its competitors, “what we’ve developed up front is a machine that is better, more affordable, and automated,” claims de Fusco. “The power of the solution is in allowing people to access the DNA of cells which are taken off the platform.”

Dr. Dempsey maintains that Cynvenio’s platform is the only one that enables the direct molecular analysis of CTCs drawn from whole blood. Even so, it’s unlikely that Cynvenio will be in the business of selling lots of machines.

What’s more probable, de Fusco says, is that the company will establish core-like facilities for customers to access its technology. “If you could get hundreds of samples processed in two days by sending a FedEx envelope, that’d be preferable to having to buy machines for hundreds of thousands of dollars, set up the personnel, and train your lab,” he says.

Among the company’s initial foci are breast cancer, lung cancer, and melanoma. While most of its partners and customers to date have been oncology research centers, within the next 12 months Cynvenio expects to launch services for doctors and patients, respectively.

“We’re really bifurcating as a company,” de Fusco says. In addition to Cynvenio’s research customers, “we’re supporting, increasingly, individual doctors and their patients,” he adds.

To the Patients

With the launch of additional doctor- and patient-focused services, Cynvenio hopes to achieve three goals: To enable early detection—the cornerstone of modern oncological care; to help physicians (and pharma) tailor patients’ treatments; and to enable longitudinal monitoring of patients’ cancer progression.

“Sequencing tumors derived from blood has value today, and it’s important that we get this technology to the people that need it,” Dr. Dempsey says.

In preparation for coming service launches, Cynvenio has hired an as-yet unannounced vp of sales and marketing, and plans to ramp up its commercial activities.Still, marketing technologies such as Cynvenio’s is not without its challenges.

“There is so much about genomics that is not yet clear in terms of regulatory approval and reimbursement codes,” de Fusco says. “A lot of labs and customers are trying to figure out how to make a viable offering out of this. I’m not even saying a viable business, I’m saying: How do we get this closer to the patient in a way that everybody with a few thousand dollars can process?”

The fact that Cynvenio refuses to sit cozily in an increasingly crowded CTC technologies market is but a sign of changes to come.

Competitive interests aside, however, “everybody who is working in this field is trying to bring a tool that will better decision-making for doctors trying to deal with patients who have chronic diseases,” Dr. Dempsey says. “That’s the particular challenge that most exercises us.”

Cynvenio Biosystems

Location: 2260 Townsgate Rd #2
Westlake Village, CA 91361

Phone: (805) 777-0017

Website: www.cynvenio.com

Principal: André de Fusco, CEO

Number of Employees: 28

Focus: Cynvenio isolates rare cells from whole blood and performs molecular analyses for biomedical research, drug development, and diagnostics.

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