WaferGen Bio-systems, Inc. engages in the development, manufacture, and sale of systems for gene expression quantification, genotyping, and stem cell research for the life sciences and pharmaceutical drug discovery industries. The company is primarily focused on marketing an open format genetic analysis system, the WaferGen SmartChip System, which provides a range of high throughput capabilities, including messenger RNA (ribonucleic acid), microRNA, and lncRNA expression level measurement, as well as single nucleotide polymorphism genotyping. The company offers its first generation SmartChip 5K System, which is a real-time polymerase chain reaction (PCR) tool enabling scientists to study various genes simultaneously clustered in gene specific pathways. The company also offers the SmartChip MyDesign System, which is the second-generation instrument with upgraded capabilities. The SmartChip System’s high density, nanoliter-scale format could provide throughput levels that facilitate the development of life science clinical research solutions at a fraction of the time and cost possible with existing competing systems. Products SmartChip System The company’s SmartChip System provides a suite of gene expression and genome analysis technologies enabling both biomarker discovery and validation on a single platform with the sensitivity and accuracy of real-time PCR. Its SmartChip Real-Time PCR System consists of two instrumentation components, such as a SmartChip MultiSample Nanodispenser (MSND) for applying sample, assay and reaction mix to the SmartChip Panels; and a SmartChip Cycler for thermal cycling and collecting data from the real-time PCR assays. For large studies, the company’s SmartChips are provided with sub-nanoliter (1-billionth of a liter) oligoneucleotide reagents of the customer’s choosing pre-loaded in the wells. For smaller projects, the user has the flexibility to purchase empty SmartChips and both samples and assays could be dispensed into the SmartChips at the customer’s site using the MSND. The company’s SmartChip Panels are designed with evaporation control measures that allow for the use of nanoliter volumes, thermal cycling, and temperature control. Its software system also analyzes the high throughput data after the completion of the real-time PCR analysis. SmartChip Target Enrichment (TE) System The concept of the SmartChip TE System is to use the SmartChip consumable for amplifying the targets of interest through PCR and then remove the resulting amplified material for further processing prior to sequencing. By having individual PCR reactions, the SmartChip TE System offers a controlled chemo-enzymatic process that might translate into sequencing results. The company is planning to offer multiple consumable formats of different densities (number of nano-wells), so that depending on the number of targets required for a particular study, a single sample could be dispensed through the whole chip. Apollo 324 Library Preparation In January 2014, the company acquired all of the assets of IntegenX Inc.'s product line used in connection with developing, manufacturing, marketing, and selling instruments and reagents relating to library preparation for next generation sequencing, including the Apollo 324 instrument and the PrepX reagents. The Apollo 324 System is a walk-away automation platform offering deoxyribonucleic acid (DNA), RNA-Seq, and ChIP-Seq library preparation kits for analysis on next-generation sequencing platforms from Illumina, Inc. (GA, HiSeq, and MiSeq); Life Technologies Corporation (Ion Proton and Ion Torrent PGM); and Roche (GS Junior, GS FLX, and GS FLX+). The PrepX automation protocols and reagent kits enable the set-up of a run with approximately 15 minutes of hands-on time. The user could return in approximately 90 minutes for sequencer-ready DNA or ChIP-Seq libraries, or approximately 5 hours for RNA-seq libraries. The system offers the flexibility to start a run with a single library without wasting reagents. The automated Apollo 324 library prep solution serves a set of clients from university research labs, pharmaceutical and agricultural companies, to diagnostic clinical labs. Market Applications of the SmartChip System Biomarker Discovery and Validation: New targets for drugs could be identified through the analysis of gene profile expression (biomarkers) in diseased cells. Applications include cancers, arthritis, and lung diseases. Drug Efficacy and Optimization: Genetic analysis is being used to determine the likely toxicity (toxicogenomics) of new drugs and the likelihood of therapeutic response to a specific genetic profile (pharmacogenomics). Drug Response Monitoring: Patient outcomes could be improved by evaluation of a proposed drug’s potency and specificity to determine individualized patient dosing, thereby decreasing adverse drug reactions and improving drug efficacy. Detection of Rare Mutations: The Cancer Genome Project is using the human genome sequence and high throughput mutation detection techniques to identify somatically acquired sequence variants/mutations and hence identify genes critical in the development of human cancers. Research and Development The company’s research and development expenses were approximately $5.40 million for the year ended December 31, 2013. Intellectual Property and Other Proprietary Rights The company has four patents issued and five pending in the U.S. with respect to its SmartChip products and technologies, and various pending SmartChip-related patent applications worldwide. The company also has one U.S. patent pending with respect to its Apollo 324 products and technologies. Competition The company competes with Life Technologies Corporation; Fluidigm Corporation; Illumina, Inc.; Agilent Technologies, Inc.; and PerkinElmer, Inc. History WaferGen Bio-systems, Inc. was founded in 2002.
wafergen bio-systems inc
7400 Paseo Padre Parkway
Fremont, CA 94555
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