Affymetrix and Vita Genomics Collaborate to Develop Microarray-based IVD Products
Decmber 26, 2005
Affymetrix Inc. (Nasdaq: AFFX) and Vita Genomics announced today that Affymetrix has granted Vita Genomics and its fully owned subsidiary, Shanghai GeneCore BioTechnologies, non-exclusive access to Affymetrix microarray technology to develop and market in -vitro diagnostic (IVD) tests for Alpha Interferon Treatment response in patients with HBV and HCV, as well as for early onset and allergic asthma in infants and young children. The resulting microarray-based IVD products would provide clinicians with better diagnosis methods and more efficient approaches for treating patients and managing these diseases.
As part of the Powered by Affymetrix(TM) program, Vita Genomics is able to incorporate Affymetrix' patented arrays into its molecular diagnostic assays developed to predict drug efficacy prior to treatment and assess risks to facilitate disease prevention.
"Application of using single nucleotide polymorphisms (SNP) for translational medicine studies is a trend in the pharmaceutical industry in the post Human Genome Project era," said Ellson Chen, Ph.D., president and CEO at Vita Genomics. "We, as a discovery/specialty CRO company, are pleased to be a partner with Affymetrix, a world-leading microarray tooling company, to synergistically commercialize in vitro diagnostic products in this field."
"The microarray-based tools and applications in the Powered by Affymetrix program are accelerating the discovery and implementation of HBV, HCV and asthma companion and predictive diagnostics in this era of molecular medicine," said Robert Lipshutz, Ph. D., senior vice president, Molecular Diagnostics and Emerging Markets at Affymetrix. "We are pleased that another innovator in the diagnostic field like Vita Genomics has adopted our proven technology platform for its in vitro diagnostic products."
"The development of companion test for certain drugs, especially for those drugs with important side - effects or drugs that only benefit subpopulation groups, is reaching the next stage with this partnership," said John Gu, Ph.D., senior vice president and Chief Business Officer of Vita Genomics. "By using the Affymetrix platform, Vita Genomics could streamline its product development processes, expedite product registration and ultimately accelerate the time to reach the market."
Under the Powered by Affymetrix program, companies license technology from Affymetrix to develop innovative microarray products. This includes the GeneChip(R) System 3000Dx (GCS3000Dx), the first microarray instrumentation system for molecular diagnostic laboratories. The GCS3000Dx has been granted regulatory clearance by the U.S. Food and Drug Administration and is CE marked in the European Union for in-vitro diagnostic use. The custom-designed technology is being used in many applications, including clinical diagnostics, forensics, animal, industrial and food testing.
Affymetrix scientists invented the world's first high -density microarray in 1989 and began selling the first
commercial microarray in 1994. Since then, Affymetrix GeneChip(R) technology has become the industry standard in molecular biology research. Affymetrix technology is used by the world's top pharmaceutical, diagnostic and biotechnology companies as well as leading academic, government and not-for-profit research institutes. More than 1,300 systems have been installed around the world
and more than 3,000 peer-reviewed papers have been published using the technology. Affymetrix' patented photolithographic manufacturing process provides the most information capacity available today on an array, enabling researchers to use a whole-genome approach to analyzing the relationship between genetics and health. Affymetrix is headquartered in Santa Clara, Calif. with subsidiaries in Europe and Asia, as well as manufacturing facilities in Sacramento, Calif. and Bedford, Mass. The
company has about 1,000 employees worldwide. For more information about Affymetrix, please visit the company's Web site at www.affymetrix.com.
About Vita Genomics:
Vita Genomics was founded in March of 2001 and has since set up working labs at its Taipei headquarters and Shanghai subsidiary. The company has over 120 employees between its headquarters in Taipei, its international business office in San Diego, Calif. and its research center in Shanghai, China. Vita Genomics is a bio -pharmacogenomics company, which focuses on biomarkers discovery, product development, bioinformatics, and specialized CRO service for the pharmaceuticals and biotech companies. Vita Genomics' proprietary technologies elucidate genes, mutations, and pathways involved in diseases with genetic predisposition, and drug adverse reactions in patients. Its R&D projects include infectious diseases, immune disorders, cancers, and neuro-degenerated diseases, for early detection, drugs efficacy prediction, and disease stage characterization. Several key products are under pre-marketing trials. Shanghai GeneCore BioTechnologies, a solely owned subsidiary of Vita Genomics, is one of the first biotech companies established 1997 in China. Its business includes diagnostic products, research-use reagents, and service for DNA sequencing, RNA gene expression profiling, and molecular diagnostics for IVD. It has 45 employees and several dozens of sales representatives. For more information about Vita Genomics and Shanghai GeneCore BioTechnologies, please visit the company's website at www.vitagenomics.com, and www.genecore.com.
All statements in this press release that are not historical are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix' "expectations," "beliefs," "hopes," "intentions," "strategies" or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risks of the Company's ability to achieve and sustain higher levels of revenue, higher gross margins, reduced operating expenses; uncertainties relating to technological approaches, manufacturing (including risks related to the Company's ability to achieve hoped-for manufacturing yields for certain array products, including the ability to identify and resolve manufacturing problems), product development (including uncertainties relating to commercial and
technological success of the strategic alliance between Vita Genomics and Affymetrix discussed in this press release); personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties relating to sole source suppliers; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix' Form 10-K for the year ended December 31, 2004 and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forwardlooking statements contained herein to reflect any change in Affymetrix' expectations with regard
thereto or any change in events, conditions, or circumstances on which any such statements are based.
NOTE: Affymetrix, the Affymetrix logo, and GeneChip are registered trademarks owned or used by Affymetrix Inc.