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University of Pittsburgh Earmarks $350K from NIH Grant for WaferGen Real-Time PCR Studies

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This article was originally published on Feb. 3.

By Ben Butkus

Wafergen Biosystems said this week that researchers at the University of Pittsburgh have earmarked $350,000 from an NIH grant to pay for research that will use Wafergen's SmartChip real-time PCR system as part of a larger multi-institution study on the genomics of chronic lung disease.

Researchers at the University of Pittsburgh Medical Center will use the money primarily to purchase consumable chips from Wafergen to use with a SmartChip system that they have loaned from the company, Wafergen Chairman and CEO Alnoor Shivji told PCR Insider this week.

However, Wafergen also anticipates that the researchers will eventually purchase the most up-to-date version of the system to continue the research, Shivji added.

Although the research will provide some short-term revenues for Wafergen, it more importantly serves to validate the SmartChip system in advance of its full commercial launch, which will likely be sometime next quarter, Shivji said.

"Yes, for us it results in revenue from chips, and ultimately it will also result in revenue from a platform," Shivji said.

"I think what is most important is that UPMC really was our first external customer to validate the platform," Shivji added. "That's a pretty important milestone for us. It's an endorsement from a large institution that this is now a commercial instrument."

The SmartChip system comprises consumable SmartChips, each having 5,184 nanowells pre-programmed with gene-specific reaction content; a nanodispenser for applying sample and reaction mix to the chips; and a thermal cycler for performing and collecting data from the real-time PCR assays.

The UPMC researchers are investigating gene expression in the areas of advanced lung disease — in particular chronic obstructive pulmonary disorder and idiopathic pulmonary fibrosis — as part of a multi-institute consortium that includes Harvard University, Boston University, National Jewish Hospital, and Wake Forest University.

That consortium, called the Lung Genomics Research Consortium, was awarded a two-year, $11 million grant in October from the National Heart Lung and Blood Institute under the American Recovery and Reinvestment Act.

Wafergen said that UPMC is receiving $3.5 million of that money, a tenth of which will be used by researchers to support their work with the SmartChip system.

"Though these projects, we hope to enable the development of personalized therapies by allowing clinicians to identify individuals at risk of developing chronic lung diseases, diagnosing these conditions at an earlier stage, and identifying novel mechanisms that cause the diseases," project collaborator Steven Shapiro, professor and chairman of medicine at UPitt, said in a statement.

"We will use Wafergen's SmartChip real-time PCR system to discover and validate new biomarkers as part of these personalized medicine projects," Shapiro added.

Shivji further explained that Shapiro and colleagues have been alpha- and beta-testing the Wafergen system, and used it to discover new biomarkers for IPF and a previously undiscovered gene signature for COPD in an effort to develop ways to distinguish between the two lung diseases in patients.

Now, the researchers will use SmartChip to validate the biomarkers using high-throughput PCR, Shivji said. "My understanding is that the $350,000 is more toward the purchase of our consumables," Shivji said. "Later on the plan is for them to also procure the instrument. At some point we will replace the current instrument with the most up-to-date version, and they will pay for that."

The vote of confidence comes at a crucial time for Wafergen. Fresh off of two separate rounds of private financing – a $6.2 million placement last summer and a $5.1 million offering closed last month – the Fremont, Calif.-based company hopes to launch a full commercial version of SmartChip "in the next quarter or so," Shivji said.

Until now, the company has been making SmartChip available on a limited basis, and besides UPMC, Wafergen has placed beta versions with researchers at the University of Texas Southwestern Medical Center, Duke University, and an undisclosed hospital in Europe, Shivji said.

And UPMC's use of SmartChip as part of the Lung Genomics Research Consortium has opened the door for the company to approach other members of the consortium and gauge their interest in the system.

Wafergen has also been attempting to drum up interest in SmartChip by conducting in-house research using the system on a fee-for-service basis. In November, the company moved into a new facility to begin offering the research services in December.

"A number of customers have given us purchase orders for service, where they give us samples, and we send them results," Shivji said.

Next up for the company is Cambridge Healthcare Institute's Molecular Medicine Tri-Conference, being held this week in San Francisco. Wafergen said that it is presenting a poster on Wednesday and Thursday discussing how the SmartChip Human Oncology Gene Panel was used to quantify changes in gene expression levels in breast and lung tumors using real-time PCR.

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