BOTHELL, Wash., Feb. 10 /PRNewswire-FirstCall/ -- Epoch Biosciences, Inc. , a provider of proprietary products that accelerate genomic analysis, announced it has entered into a worldwide non-exclusive license with Celera Diagnostics, a joint venture between the Celera Genomics Group and Applied Biosystems Group of Applera Corporation, for incorporation of its MGB(TM) Technology and Eclipse(TM) Dark Quencher Technology into Celera Diagnostics' products for selected infectious diseases.
The license allows Celera Diagnostics to manufacture, sell and distribute TaqMan(R) probes that utilize Epoch's minor groove binder and quencher in selected products. Under the license agreement, Epoch will receive license fees and royalties on sales of such licensed products to end users. Additional terms of the agreement were not disclosed.
William G. Gerber, M.D., chief executive officer of Epoch, said, "This agreement is a milestone for Epoch because it represents our first business agreement in the human diagnostics field. Our initial diagnostics strategy is to introduce a large portfolio of analyte-specific reagents for use by large laboratories, and during the past year we listed 17 ASRs with the FDA for the detection of infectious and inherited diseases. We plan to market many reagents directly and expect to introduce 20 in the first half of 2004, but we also intend to use partners for distribution of certain targets. The alliance between Celera Diagnostics and Abbott Laboratories, wherein Abbott distributes certain products developed and manufactured by Celera Diagnostics, is a powerful combination for accelerating the global impact of advanced molecular diagnostics."
Kathy Ordonez, president of Celera Diagnostics, said, "We believe Epoch's technologies can help us achieve our goal of bringing diagnostics tools and products to clinical laboratories that provide timely and actionable information to benefit their ultimate customers; the medical decision makers and patients."
Analyte-specific reagents (ASRs) are assay components used by clinical laboratories to develop assays that provide medically significant information to physicians and hospitals. ASRs are exempt from 510(k) regulations for diagnostic products, but are manufactured under cGMP guidelines and listed with the FDA. Such components can only be sold to appropriate laboratories by registered manufacturers.
MGB technology is based on a potent class of naturally occurring antibiotics that bind to the minor groove of double stranded DNA. When attached to either the 5' or 3' terminus of DNA probes, hydrophobic binding of MGB molecules to the minor groove stabilizes DNA duplexes formed by these probes hybridizing to their complementary targets. This allows the use of shorter probes with higher sensitivity to mismatches, which is particularly beneficial in the design of probes for the analysis of single nucleotide polymorphisms (SNP) or short, conserved sequences of viral genomes or multi- gene families for which limited target sequence is available. Epoch Biosciences was the first to recognize and utilize the enhanced performance and expanded assay design flexibility that MGB technology provides for DNA probe based detection systems.
MGB is currently incorporated into MGB Eclipse(TM) Probe Systems sold by Epoch and in TaqMan(R) products sold by Applied Biosystems in the research field, and in BioControl System's food testing products.
Eclipse Dark Quencher Technology
The Eclipse Dark Quencher is a pioneering technology developed by Epoch Biosciences that when attached with a fluorescent dye to a DNA probe, suppresses the signal generated by the dye until the probe binds to its target DNA. It offers higher sensitivity in real-time PCR probes due to lower background fluorescence, is applicable in a broad range of detection systems, quenches a broader dye emission spectra range, and is compatible with simple and robust DNA synthesis procedures.
The Eclipse Dark Quencher is currently incorporated into MGB Eclipse Probe Systems sold by Epoch, in other TaqMan products sold by Applied Biosystems, in the Invader System sold by Third Wave Technologies, and in QuantiTect(TM) gene expression assays sold by QIAGEN. The Eclipse Dark Quencher is also licensed to Applied Biosystems for use in environmental testing products and to Takara for use in real-time PCR detection assays, and is distributed by Glen Research for sale into the research community.
About Epoch Biosciences
Epoch Biosciences, Inc. develops and sells proprietary products with commercial applications in the genomics and molecular diagnostics fields. Epoch's technology has numerous applications including the detection of inherited diseases, single nucleotide polymorphisms (SNPs) to identify individuals at risk for disease or adverse drug reactions, and gene expression measurement. The Company's chemical reagents enhance the performance of genetic analysis procedures, and are compatible with the majority of DNA analysis systems currently employed or under development for research and diagnostic uses. The Company has an established presence in the research market through licenses to leading genomics companies, global distribution agreements and direct sales to end-users. Epoch also participates in the industrial/bioterrorism sectors and is currently entering the diagnostics market. Information about Epoch is available at http://www.epochbio.com/.
About Celera Diagnostics and Applera Corporation
Celera Diagnostics is a 50/50 joint venture between two Applera Corporation businesses, Applied Biosystems and Celera Genomics. Headquartered in Alameda, CA, Celera Diagnostics focuses on discovering novel genetic markers for disease and configuring these into new diagnostic tests to predict, characterize, monitor and select therapy for cardiovascular disease, auto-immunity, central nervous system disorders, and cancer. Information about Celera Diagnostics and its infectious disease products is available at http://www.celeradiagnostics.com/.
Safe Harbor Statement
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties, including but not limited to the possibility that the products utilizing Epoch Biosciences' technologies may be ineffective, or that third parties assert proprietary rights that preclude Epoch from marketing Epoch's products and technologies. These factors and others may cause actual results to differ materially from the anticipated results. Additional information about potential risk factors that could affect Epoch's business and financial results is included in Epoch's Annual Report on Form 10-K for the year ended December 31, 2002 and in other reports filed from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as to the date of this release and Epoch undertakes no obligation to
update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise.
MGB and Eclipse are trademarks of Epoch Biosciences, Inc. Applied Biosystems is a registered trademark and Celera, Celera Diagnostics and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the US and/or certain other countries. TaqMan is a registered trademark of Roche Molecular Systems, Inc., licensed to Applera Corporation. QuantiTect is a trademark of QIAGEN, N.V.
Epoch Biosciences, Inc.