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WaferGen Announces Full Commercial Launch of SmartChip Real-Time PCR System

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WaferGen announced today the full commercial launch of the SmartChip real-time PCR system, the company's flagship nanowell-array PCR platform for gene expression studies and biomarker discovery and validation.

The SmartChip system has been under development for the last few years and WaferGen has been working with early-access customers over the last several months to prepare the platform for commercial launch.

"With full product availability, and manufacturing and sales [and] support readiness, we will now focus on targeting the top 20 biopharmaceutical companies involved with drug development and biomarker profiling and the top 40 translational medical centers involved with pathway-based biomarker discovery," Alnoor Shivji, chairman and CEO of WaferGen, said in a statement.

The system comprises 5,184-well consumable chips preloaded with target-specific primers; a single-sample or multi-sample nanodispenser for dispensing samples and master mix onto a SmartChip panel under vacuum conditions; and the SmartChip cycler, which performs PCR thermal cycling, data collection, and amplicon melting.

Users will also be able to receive a human microRNA panel, which provides a profile of approximately 800 miRNAs with four replicates on a single SmartChip and can be used with RNA from cell lines, frozen tissue, and formalin-fixed paraffin-embedded tissue; and a human oncology gene panel, which provides approximately 1,000 genes with four replicates per chip for profiling expression of oncology-related gene targets.

Customers can also work with WaferGen to design custom gene panels for SmartChip, the company said.

Mona Chadha, WaferGen's chief operating officer and executive vice president of marketing and business development, told PCR Insider that the US list price for the SmartChip instrument system will be in the neighborhood of $150,000, the same price that UK-based analyst Edison Investment Research reported in March.

Edison Investment Research also reported that on average, the system is expected to use 400 to 500 SmartChip consumables per year, with each chip costing $800 to $1,100. Chadha did not disclose specific consumable pricing, but said that that it will vary depending on the content provided on each chip.

WaferGen is positioning the SmartChip system as a bridge between hybridization-based microarray technology and PCR.

"Because of the compressed dynamic range and poor sensitivity exhibited in microarray technology, hybridization-based technologies provide scientists with only a partial view of the expression profile, in some cases limiting the data to only 20 to 30 percent of the expressed genes," David Gelfand, WaferGen's chief scientific officer, said in a statement.

Real-time PCR, on the other hand, has been favored by researchers because it more sensitively and precisely measures gene expression, "but it lacked the target density and cost efficiencies of existing microarrays," Gelfand added. The SmartChip system combines "the high target density of microarrays with the benefits of real-time PCR … on a single platform to enable scientists to measure gene expression more precisely, with more sensitivity and accuracy" with high throughput and lower cost, Gelfand said.

The company began the process of commercializing SmartChip earlier this year by launching an early-access program that was designed to tweak the system before full commercial launch and generate some early revenues.

"We've sold full systems to our early-access customers," Chadha said. "Now it's really having complete readiness from a manufacturing point of view, and we've geared up on gene panel manufacturing and production. We're also going to embark on targeted marketing programs that will allow our salespeople to go talk to a broader audience and penetrate the market on a global basis."

Early-access customers for the platform include the University of Texas Health Science Center at Houston; Ghent University; Stanford University; University of California-San Francisco; University of Pittsburgh; University of Southern California; University of Texas-Southwestern; Kyoto University; and an undisclosed US biotech company.

Also, last week WaferGen disclosed the identity of a second Japanese early-access customer, contract services provider DNA Chip Research, which purchased 100 SmartChip consumables and will use the platform to provide miRNA, oncogene, and custom gene expression research services to Japanese scientists.

"We chose the SmartChip system to supplement our microarray offerings in order to attract advanced molecular biologists to use our services," Ryo Matoba, president of DNA Chip Research, said in a statement.

With the full commercial launch of SmartChip, WaferGen will hope to recoup some of the cash it has pumped into developing the system over the last few years and eat away at a deficit that stood at $30.3 million at the end of last year.

In order to prep the system for full commercial launch, WaferGen has been periodically tapping investors for cash reserves, most recently a $7.2 million registered direct offering, which netted the company $6.7 million (PCR Insider 7/8/2010).

In addition, WaferGen closed a private placement in December 2009, netting $4.7 million in net proceeds; and raised approximately $5.6 million in June and August 2009; and $13.4 million from two private placements in 2008 and 2007.

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