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WaferGen Preps New Facility, Rolls out SmartChip Services; Standalone Platform to Launch in H2

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By Bernadette Toner

WaferGen is in the process of moving its operations to a new, larger facility in line with the recent launch of gene expression-profiling services based on its SmartChip real-time PCR system, company officials said this week.

A standalone version of the SmartChip system will be available for sale in the second half of the year, they added.

Mona Chadha, executive vice president of marketing and business development at WaferGen, told PCR Insider that the company is currently conducting its SmartChip Services in the new facility, while its research and development and manufacturing operations are located in its current space.

"As the facility gets ready to accommodate the rest of the people, we will all move over there," Chadha said.

The company disclosed in a filing with the US Securities and Exchange Commission last November that it had signed a lease the previous month for 19,186 square feet of office and lab space for the new headquarters, which is located in Fremont, Calif. The lease on its current headquarters, an 11,222-square-foot facility also located in Fremont, expires in March.

Chadha said that the new space will help support the new SmartChip Services offering, and will also enable the firm to expand its R&D and manufacturing operations. The company currently employs 32 people and has "aggressive plans" to hire new research, service, and commercial staffers this year.

WaferGen announced in January 2008 that it had completed developing the alpha version of the SmartChip system. Since then, the platform has been in alpha and beta testing at the University of Pittsburgh Medical School and the University of Texas Southwestern Medical Center, but has not yet been available for customers.

Chadha said that the services business, which it launched this month, is a key part of the platform rollout.

"Part of our development process is building relationships with customers in order to utilize the technology and generate data on that," she said. "So the services business comes in very, very handy — to be able to run samples for customers and generate data."

She noted that the company expects the services offering to appeal to academic customers who are writing grants but don't yet have funding to purchase equipment for their labs. "They really need to have data available on small sets of samples that they can then submit for grants," she said.

Pharmaceutical firms conducting feasibility studies are another target customer base for the service offering. "A lot of pharmas are outsourcing [research], so they, too, want to be able to use the service and generate data in order to then send out many more samples for doing biomarker discovery."

Chadha said that the firm is seeing interest in the service from academic customers as well as "pharmaceutical companies that are involved more with companion diagnostic development," but declined to provide further details.

The company is currently offering services based on two panels: one for oncology and one for microRNA research. Pricing for the service is still being determined, Chadha said, and currently depends on volume and other factors.

Best of Both Worlds?

WaferGen touts the SmartChip system as being the first system to combine the best features of microarrays and real-time PCR — namely, the ability of microarrays to conduct genome-wide analysis and the sensitivity and accuracy of real-time PCR.

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The platform is being developed to conduct 33,750 assays on a single chip, as compared to the maximum 1,536 wells for standard real-time PCR systems. Furthermore, each of the system’s wells can support a real-time PCR reaction with 100 nanoliters of sample, which the company said is a 1,000-fold decrease in the amount of reagent and sample required by typical real-time PCR technologies.

The current version of the system includes 5,184 nanowells.

According to documents filed last year with the SEC, WaferGen expects the cost per data point for the SmartChip system to be on the order of 3 cents, as opposed to $1 per data point for standard real-time PCR. The company said that the platform will be capable of generating 100,000 data points per experiment when fully developed.

WaferGen said that the platform should also provide considerable time savings when compared to existing PCR systems, with the ability to analyze a whole genome in a single day as compared to weeks or months.

The company is targeting the platform for the global gene-expression and genotyping market, which it projects will be worth around $5 billion by 2012.

Chadha said that the SmartChip will give researchers "the opportunity to explore and discover gene markers independent from the data that they are getting from microarrays" by taking a pathway-based approach to analyzing disease genes. "And because you're getting real-time PCR performance, you have the ability to get a larger dynamic range and higher capability than you typically get with microarrays."

In addition to microarrays and standard real-time PCR, the SmartChip will compete with medium-throughput gene-expression systems from companies like Fluidigm and BioTrove, which Life Technologies acquired last year [PCR Insider 12-17-09].

WaferGen acknowledged these competitors in its SEC filing, but noted that such systems "are associated with high instrument and running cost, suffer from poor performance, and will be difficult to scale up to whole genome on a single chip."

Chadha told PCR Insider that the Fluidigm and BioTrove systems do not offer the same degree of flexibility that the SmartChip will enable. "We offer a huge amount of flexibility with the number of genes that you can run in triplicate," she said.

"Our first chip does 5,100 assays, so you can run many genes in triplicate, along with being able to run many controls. So there's not another platform out there that gives you the same level of information for a discovery platform."

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