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WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art gene expression, genotyping, cell biology and stem cell research systems, today announced that academic researchers have successfully demonstrated the performance of the company's SmartChip(TM) Real-Time PCR System in the initial phase of the platform's ongoing alpha testing program. Initial tests conducted at the University of Pittsburgh School of Medicine have demonstrated a number of the SmartChip system's key analytical specifications, showing the product's complete workflow on 1,000 oncology genes using small amounts of samples from emphysema, idiopathic pulmonary fibrosis (IPF) and healthy patients.
Key workflow elements that have been successfully demonstrated include primer-ready SmartChips and the drying and reconstitution of primers for rapid high-throughput 100 nL real-time polymerase chain reaction (PCR). Additionally, the platform's ability to perform PCR in nano-volumes without any pre-amplification has been demonstrated using various control genes, as well as indicators of other genes that are known to be expressed in patient samples. The next phase of the alpha testing program will focus on using the SmartChip system to identify biomarkers of interest. Upon completion of the ongoing alpha testing program, data will be presented and/or published in appropriate academic venues.
"The successful demonstration of the performance of the revolutionary SmartChip system in a rigorous research setting is a tremendous step forward for this novel platform. We are particularly excited that the platform has shown the ability to capture the expression of genes that have not been able to be seen using microarrays," stated Alnoor Shivji, WaferGen's chairman and chief executive officer. "We expect that this is just the first milestone related to the SmartChip alpha testing program and look forward to new findings on biomarker discovery and validation."
The SmartChip alpha testing program involves the study of RNA isolated from lung tissue samples from healthy patients, as well as patients with chronic obstructive pulmonary disease (COPD) and IPF. Researchers are screening these RNA samples with the SmartChip Real-Time PCR System in order to assess the platform's performance in conducting novel gene expression research.
About the SmartChip Real-Time PCR System
The SmartChip Real-Time PCR System(TM) is designed as the first whole genome, high-throughput gene expression real-time PCR platform. This innovative system, combined with next-generation chemistry and optimized assays being developed by WaferGen, promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets. Based on collaborations established with leading research institutions, WaferGen believes that the SmartChip Real-Time PCR System is positioned as the platform of choice for biomarker discovery and validation. It is estimated that the genetic analysis market alone (comprised of gene expression and genotyping analysis) had approximately $2.4 billion in worldwide revenues in
2006 ($1.74 billion for gene expression and $650 million for genotyping). Total global revenue for this market is estimated to reach approximately $5.0 billion by 2012.
WaferGen believes the SmartChip Real-Time PCR System will be the first platform to combine the high-throughput capability and cost efficiencies of existing microarrays, with the sensitivity and accuracy of real-time PCR. Specifically, the SmartChip Real-Time PCR System's high density, rapid cycling configuration is expected to provide industry-leading throughput levels, while offering discovery and validation capabilities in a single step. The result will be the ability to conduct gene expression research at a fraction of the time and cost currently produced by existing instrument systems. This decrease in research time has broad economic implications across the drug development industry, particularly for pharmaceutical companies seeking avenues for reducing time to market for their therapeutics. Further, the company believes such throughput will dramatically impact the cost of such assays.
Beyond the significant time and cost advantages, the simplicity of the SmartChip Real-Time PCR System is unparalleled. The system will provide a number of key ease-of-use features including content-ready chips with gene panels optimized for cancer, toxicology and whole genome. The user-friendly SmartChip Real-Time PCR System will be preloaded with some of the reaction components. At the same time, the system will only require a very small sample size as compared to other technologies and platforms and will offer real-time detection and sophisticated read-out options while assuring quantitative real-time PCR performance.
About WaferGen Biosystems, Inc.
WaferGen Biosystems, Inc. is a leader in the development, manufacture and sale of state-of-the-art systems for gene expression, genotyping, cell biology and stem cell research for the life science and pharmaceutical industries. The company is actively developing its SmartChip(TM) product for the gene expression and genotyping markets. SmartChip is being developed as the first whole genome, high throughput gene expression real-time polymerase chain reaction (PCR) platform. This innovative system, combined with next-generation chemistry and optimized assays being developed by WaferGen, promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets. Based on collaborations established with leading research institutions, WaferGen believes that the SmartChip Real-Time PCR System is positioned as the platform of choice for biomarker discovery and validation. WaferGen currently markets its SmartSlide(TM) family of products to companies and organizations involved in stem cell and cell biology research. SmartSlide, which was launched in 2006, represents the first fluidics integrated micro-incubators enabling cell biology and stem cell research. Representative SmartSlide customers include Harvard University, Mayo Clinic, California Institute of Technology (CalTech), Abbott Labs, and the National Institutes of Health (NIH).
This press release contains certain "forward-looking statements". Such statements include statements relating to the company's goals, plans and projections, anticipated results of research, performance, reliability and cost-effectiveness of the company's SmartChip and other systems, and other statements that are not historical facts, including statements which may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words.
Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that: (i) the company may be unsuccessful in commercially developing its products or in achieving market acceptance of new and relatively unproven technologies; (ii) the company will need to raise additional capital to meet its business requirements in the future and the company may not be able to do
so on reasonable terms or at all; (iii) the company's proprietary intellectual property rights may not adequately protect its products and technologies; and (iv) the company expects intense competition in its target markets, including from companies that have much greater resources than the company, and there can be no assurance that the company will be able to compete effectively. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2007, and its subsequent Quarterly Reports on Form 10-Q filed with the SEC. Investors and security holders are urged to read this document free of charge on the SEC's web site at www.sec.gov. The company does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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Vida Communication (on behalf of WaferGen)
Stephanie Diaz (investors)
Tim Brons (media)
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