WaferGen launches SmartChip System for discovery, validation of biomarkers

WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art genomic analysis systems, today announced it has launched the breakthrough WaferGen SmartChip Real-Time PCR System, the next-generation Real-Time PCR system for discovery and validation of biomarkers, or gene expression patterns, on a single platform.  The SmartChip System is designed to provide accurate, highly sensitive and high-throughput gene expression profiling capabilities to researchers, clinicians and pharmaceutical companies.  

"The launch of the full SmartChip System is a key milestone for WaferGen that signals the next step of SmartChip commercialization to expand on the success of our Early-Access Program and collaboration activities," said Alnoor Shivji, chairman and CEO, WaferGen.   "With full product availability, and manufacturing and sales/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 and validation."

SmartChip System to Enable New Model of Drug Research by Addressing Shift in Healthcare Enabled by Genomics

"WaferGen's SmartChip System will make a significant contribution to the advancement of drug research by addressing the shift in healthcare enabled by genomics," said Andre Marion, co-founder and former chairman and CEO of Applied Biosystems (now part of Life Technologies), and a member of WaferGen's Scientific Advisory Board. "Genomics has shifted biopharmaceutical research away from the previous model of blockbuster drugs targeting broad patient segments with significant adverse events, and an expensive and inefficient drug development process.  

"The new model is that of genomic profiles that determine therapy selection and monitoring, enable companion diagnostics, improve patient stratification to maximize the outcome of clinical trials, and accelerate and lower the costs of drug development by failing early and failing fast. The WaferGen SmartChip System provides researchers with a tool that advances this new model by utilizing cost-effectively the benefits of Real-Time PCR technology," concluded Marion.

SmartChip System Adds Target Density, Cost Efficiencies to Real-Time 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 20-30% of the expressed genes.  Real-Time PCR has been the validation technology of choice because it is a more sensitive and precise method to measure gene expression, but it lacked the target density and cost efficiencies of existing microarrays," said David Gelfand, WaferGen Chief Scientific Officer and pioneer of PCR technology.

"The WaferGen SmartChip System combines the high target density of microarrays with the benefits of real-time PCR technologies on a single platform to enable scientists to measure gene expression more precisely, with more sensitivity and accuracy in addition to high-throughput capability and cost efficiencies.  It is designed to meet the high-throughput needs of biopharmaceutical companies' clinical trials with high quality and density of data yielding improved confidence in analysis and better patient stratification – for treating and targeting patient populations," concluded Gelfand.

The SmartChip System includes:

• The SmartChip:  contains 5,184 nano-wells preloaded with target-specific primer pairs optimized for performance with the SmartChip System.
• SmartChip Human MicroRNA Panel:  provides a comprehensive human microRNA profile of approximately 800 microRNAs with four replicates 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.
• SmartChip Human Oncology Gene Panel: provides approximately 1000 genes with four replicates on a single chip for gene expression profiling oncology-related targets.  The panel includes genes from 16 functional groups, including representative kinases, cell cycle proliferation genes, signal transduction genes, apoptosis genes, DNA repair genes, and G-protein coupled receptors.
• Custom SmartChip Gene Panels:  provides opportunity to work with WaferGen scientists to customize a high-throughput, real-time PCR SmartChip assay panel to address targeted research objectives.  Researchers can choose from the WaferGen library of validated gene expression assays or have the WaferGen assay development team develop and optimize specific assays.
• The SmartChip Nanodispenser:  used to dispense a single sample and master mix into a SmartChip Panel under vacuum in a specially designed fixture and vacuum chamber.  Loads the 5,184-well SmartChip in a single step.
• The SmartChip Multisample Nanodispenser: automates the loading of up to 384 samples with a Custom SmartChip Panel, offering the highest number of samples that can be run on a nano-chip. Both the SmartChip Nanodispenser and the SmartChip Multisample Dispenser can be used to dispense samples and master mix onto the SmartChip making the system easy to use and offering customers the flexibility to analyze many genes or many samples.
• The SmartChip Cycler: The loaded chip is placed into the SmartChip Cycler and subjected to the Real-Time PCR thermal cycler, data collection and amplicon melting. Analyzed data in the form of cycle threshold and melting temperatures are downloaded and analyzed.

WaferGen Expanding on Success of Early-Access Program

WaferGen started commercializing the SmartChip Real-Time PCR System in early 2010 with its Early-Access Program, offering the SmartChip System and the SmartChip Gene Expression Profiling Services.  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.

Early customers of the SmartChip System and/or SmartChip Gene Expression Profiling Services include a total of ten major universities and service providers, such as University of Texas, Health Science Center at Houston; Stanford University; USC; Ghent University; Kyoto University; and DNA Research Inc., in the U.S., Europe and Japan.  WaferGen has also established collaborative relationships with leading universities including the University of Pittsburgh Medical Center, the University of Texas Southwestern and Ghent University.  

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 has approximately 800 human genes from the miRBase version 14.0 sequence database.

PCR Technology

Polymerase Chain Reaction (PCR) is an enzymatic process to increase the number of copies of DNA for easier detection.  Real-time PCR chemistries allow for detection of the reaction in the early phase rather than the late phase of the reaction.  The polymerase enzyme "reads" an intact DNA strand as a template and uses it to synthesize the new strand, which sets in motion a chain reaction in which the DNA template is exponentially amplified, generating millions or more copies of the DNA piece.  Real-time PCR simultaneously amplifies and quantifies (as an absolute number of copies or relative amount) a targeted DNA molecule in real time after each amplification cycle.