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Wafergen Names Early-Access Customers, Gets CE Mark for SmartChip PCR System

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This article has been updated from a previous version to include comments from Wafergen.

Wafergen Biosystems today named eight early-access customers, including US and Japanese universities and service providers, for its SmartChip real-time PCR system.

Wafergen also said that two of the three components of its SmartChip system – the SmartChip Cycler and Nanodispenser – have received CE Mark certification in Europe and Japan, which has allowed the company to ship a SmartChip system to one of the Japanese customers.

The early-access agreements provide Wafergen with an undisclosed amount of revenue, and are expected to help validate the SmartChip platform prior to its planned launch later this year, the company said.

The early-access customers include Stanford University, University of California at San Francisco, University of Pittsburgh, University of Southern California, the University of Texas Southwestern Medical Center, two undisclosed Japanese organizations, and an undisclosed US biotech company.

At least two of these customers had previously been disclosed. As reported last month in PCR Insider, researchers at the University of Pittsburgh were to use $350,000 from a National Institutes of Health grant to support research using SmartChip as part of a larger multi-institution study on the genomics of chronic lung disease.

At the time, Wafergen President and CEO Alnoor Shivji said that the company had also placed beta versions of SmartChip with researchers at UT-Southwestern and Duke University.

Shivji also said at the time that Wafergen hoped the full commercial launch of the SmartChip system would occur in the second quarter of this year. It is unclear whether the company is still adhering to that timeline.

Besides the lung disease research underway at the University of Pittsburgh, early-access customers are using SmartChip for wound healing, stem cell, and oncology research, Wafergen said.

The SmartChip system consists of consumable SmartChips, a nanodispenser, and a thermal cycler. The SmartChip contains 5,184 nanowells preloaded with primer content optimized for use with the nanodispenser and thermal cycler.

The SmartChip Nanodispenser dispenses sample and master mix onto the SmartChip under vacuum in a specially designed fixture and vacuum chamber. The dispensed chip is placed into the SmartChip Cycler and subjected to real-time PCR and amplicon melting analyses. Users can then download and analyze data in the form of threshold cycles and melting temperatures.

Wafergen said that it believes that researchers using the system can conduct gene expression research at a fraction of the time and cost of existing instrument systems.

Wafergen noted that the nanodispenser and thermal cycler components of the SmartChip system have received CE Mark certification, enabling the company to market and sell the SmartChip system in Europe and Japan where the CE mark is recognized. The SmartChip consumable chip does not require CE Mark approval, a spokesperson told PCR Insider in an email.

This certification represents "significant steps in our process toward commercialization," Shivji said in a statement.

Wafergen is providing early access to SmartChip through two routes: the first is by offering contract gene expression profiling using the system at Wafergen's Fremont, Calif., headquarters.

The company said that three of its early-access customers have signed this type of agreement. "They will bring their research to WaferGen scientists who will perform the lab work for a fee," the spokesperson said. "That accounts for some of the early-access revenue."

Wafergen's SmartChip service provides pathway-based gene expression profiling based on a human oncology gene panel. The company also recently made available a human microRNA panel comprising more than 800 microRNAs on a single SmartChip.

The remaining new customers, including one of the Japanese organizations, have already received earlier versions of SmartChip and are using the system in their own laboratories.

"In order to sell to Japan and Europe, it is essential to have a CE marking, even for early-access customers," the spokesperson said. "Therefore, we shipped the first SmartChip Real-Time PCR system to one of the two Japanese customers for revenue upon receiving CE certification."

Wafergen said that it is receiving revenue through both arrangements, though it did not disclose how much. The spokesperson confirmed, however, that the organizations using early versions of the SmartChip system in their labs paid for those instruments.

Wafergen may also realize additional revenue from those customers in the form of consumable SmartChips for use with the thermal cycler and nanodispenser. Shivji confirmed last month that this is the arrangement at the University of Pittsburgh.

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