WaferGen Announces Two Gene Expression Profiling Panels for SmartChip Real-Time PCR System for High Throughput, Cost-Effective Biomarker Discovery and Validation

FREMONT, Calif., June 10 /PRNewswire-FirstCall/ -- WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art genetic analysis systems, today announced the availability of two gene expression profiling panels for the SmartChip Real-Time PCR System that will enable microRNA and cancer pathway profiling capability.

By querying up to a thousand genes in a single sample, these panels enable discovery and validation of biomarkers in a high-throughput, highly cost-effective manner. Recently available only with the SmartChip Gene Expression Profiling Services provided by WaferGen scientists at the company's headquarters facility in Fremont, Calif., the two panels are now available for use by customers on the commercial SmartChip System.

"By offering these panels to researchers and scientists, we broaden the applicability of the SmartChip System across a spectrum of research needs, thereby expanding its market potential," said Alnoor Shivji, chairman and CEO, WaferGen.

The first panel is the SmartChip Human MicroRNA Panel that provides a comprehensive human microRNA profile of more than 800 microRNAs on a single SmartChip and is for use with RNA from cell lines, frozen tissue and formalin fixed paraffin embedded tissue (FFPE), one of the more difficult-to-work-with samples. The second panel is the SmartChip Human Oncology Gene Panel that provides approximately 1000 genes on a single chip for gene expression profiling for oncology in four replicates including representative kinases, cell cycle proliferation genes, signal transduction genes, apoptosis genes, DNA repair genes, and G-protein coupled receptors.

"The identification of tumor-specific molecular alterations has provided researchers and clinicians with new tools to characterize, based on gene expression patterns, the critical pathways regulating tumor growth. More exciting is the promise of less toxic, more effective targeted therapies. WaferGen's novel panels promise to enable researchers to evaluate the full spectrum of validated cancer biomarkers in one pass with higher fidelity than existing technologies, and at a cost that even small academic labs can afford," said Christopher Sears, PhD, Chief Scientific Officer at Ambergen, who has held joint academic appointments in the field of oncology at Children's Hospital Boston, The Broad Institute, Harvard Medical School and the Dana Farber Cancer Institute, and is a member of WaferGen's Scientific Advisory Board.

"MicroRNAs and cancer pathways are both key determinants of clinical cancer behaviors, and measuring these is critically important for fundamental cancer research and for the development of clinically useful biomarkers for diverse cancer types. The addition of microRNA and oncology gene expression panels to the WaferGen SmartChip System enables analysis of critical molecular signatures for cancer in a highly efficient and cost-effective manner," said Muneesh Tewari, M.D., Ph.D., faculty member at Fred Hutchinson Cancer Research Center and a recently added member of WaferGen's Scientific Advisory Board. Since joining the Hutchinson Center in 2005, Tewari has focused on studying the role of microRNAs in cancer, as well as on developing microRNA-based biomarker approaches for oncology. Prior to this, Dr. Tewari served in faculty and clinical positions at Harvard Medical School, Dana-Farber Cancer Institute, Brigham and Women's Hospital and Massachusetts General Hospital.

The 5,184 nano-well SmartChip uses a small amount of biological material to query either a thousand genes in a single sample, or fewer genes on many samples, enabling a workflow from discovery to validation of biomarkers while saving researchers time. By applying Quantitative Real-Time PCR Expression Profiling, the SmartChip System combines the gene expression profiling throughput of microarrays with the sensitivity, precision and dynamic range of Real-Time PCR, the gold standard of gene expression studies. The 27 built-in controls in the Human Oncology Gene Panel and the 12 built-in controls in the Human MicroRNA Panel offer added quality assurance to the results.

The company is in the early stages of commercializing the SmartChip System, and is currently offering the SmartChip System and the SmartChip Gene Expression Profiling Services as part of its revenue-generating Early-Access Program. The SmartChip System includes the 5,184-assay SmartChip, the SmartChip Cycler, and SmartChip Nanodispenser or Multi-Sample Nanodispenser. The SmartChip Gene Expression Profiling Services are provided to universities, research hospitals, pharmaceutical and biotechnology companies by WaferGen scientists at the company's headquarters facility in Fremont, Calif.

MicroRNAs

MicroRNAs are small non-protein-coding single-stranded RNA molecules of 21-23 nucleotides in length that function as negative regulators of gene expression by targeting specific messenger RNAs. This either inhibits translation or promotes messenger RNA degradation. Cancer diagnosis, prognosis, and treatment are important potential clinical applications of microRNA profiling. The SmartChip Human microRNA panel will use more than 800 human genes from the new miRBase version 14.0 sequence database.

About WaferGen

WaferGen Biosystems, Inc. is a leader in the development, manufacture and sale of state-of-the-art systems for genome analysis for the life science and pharmaceutical industries. 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 identification and validation. Combined with next-generation chemistry and optimized assays being developed by WaferGen under the guidance of David Gelfand, Ph.D., Chief Scientific Officer and one of the pioneers of PCR, this innovative system promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets.

Forward-Looking Statements

This press release contains certain "forward-looking statements". Such statements include statements relating to the expected benefits and advantages of the SmartChip microRNA and Oncology panels, the expected benefits and advantages of the SmartChip service for gene-expression research, the expected benefits and advantages of the SmartChip technology to other applications, the expected throughput levels of the SmartChip Real-Time PCR System, and other statements relating to future events or to the company's future financial performance and 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, 2009 and the Form 10Q for the quarter ended March 31, 2010. Investors and security holders are urged to read these documents 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.

SOURCE WaferGen Biosystems, Inc.