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Affymetrix and NuGEN Announce Agreement to Co-market the NuGEN WT-Ovation(TM) FFPE System.


A Whole-Transcriptome Amplification System amplification system Physiology A generic term for any group of proteins that function in coordinated sequences, forming positive feedback loops for expanding the response to a low intensity signal
Amplification systems
Coagulation,
 for Gene Expression Profiling of FFPE FFPE Formalin-Fixed, Paraffin-Embedded (tissue)
FFPE Fédération de la Fonction Publique Européenne (Staff Representation at the European Commission) 
 Samples With Affymetrix GeneChip([R]) 3' Expression Arrays

SANTA CLARA, Calif. & SAN CARLOS, Calif. -- Affymetrix Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AFFX) and NuGEN Technologies Inc., a privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 that develops and commercializes nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis.  amplification and labeling systems for small and difficult samples, announced today their agreement to co-market a solution that enables researchers to access FFPE (formalin-fixed, paraffin-embedded) tissue samples derived from years of clinical studies previously inaccessible by traditional RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 amplification methods. The NuGEN WT-Ovation[TM] FFPE System provides scientists the opportunity to conduct global gene expression analysis on their vast archives of small and degraded FFPE samples, using standard Affymetrix GeneChip([R]) 3' expression arrays.

The industry-standard Affymetrix 3' gene expression arrays enable researchers to simultaneously monitor genome-wide expression profiles. This global view helps scientists understand biological mechanisms of complex diseases and processes, and identify new drug targets in ways never before possible. Utilizing gene expression profiles as novel biomarkers for conditions such as cancer or lupus, scientists are able to more accurately classify disease, predict clinical progression and determine the likelihood of treatment success.

NuGEN's sensitive WT-Ovation[TM] FFPE System requires 50 nanograms of total RNA from FFPE samples for consistent, linear amplification yielding several micrograms of cDNA. The process takes just six hours, and when used with NuGEN's FL-Ovation[TM] cDNA Biotin biotin: see vitamin; coenzyme.
biotin

Organic compound, part of the vitamin B complex, essential for growth and well-being in animals and some microorganisms.
 Module V2 for fragmentation and labeling, allows hybridization hybridization /hy·brid·iza·tion/ (hi?brid-i-za´shun)
1. crossbreeding; the act or process of producing hybrids.

2. molecular hybridization

3.
 to GeneChip([R]) microarrays the same day. This simple, automatable process saves time, labor and precious samples, while delivering robust, high-quality results from degraded samples that may otherwise be more difficult to utilize for global gene expression profiling with standard Affymetrix 3' protocols.

"For researchers, clinicians and pharmaceutical companies with thousands of valuable tissue samples archived from lung, breast, prostate and colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States.  studies, this is a tremendous breakthrough," said Sue Pandey, NuGEN vice president of commercial operations. "Investigators have been waiting for a solution that would enable the use of these samples and the extensive prognostic and prospective clinical data associated with them to gain insight into the causes of disease and response to treatments."

"The NuGEN/Affymetrix pairing is an important step forward for biomarker discovery and validation," said Sean George, senior vice president of Global Marketing at Affymetrix. "Unlocking the treasure trove TREASURE TROVE. Found treasure.
     2. This name is given to such money or coin, gold, silver, plate, or bullion, which having been hidden or concealed in the earth or other private place, so long that its owner is unknown, has been discovered by accident.
 of information in archived FFPE samples should help accelerate the development of more effective treatments for complex genetic diseases such as cancer."

"The NuGEN WT-Ovation[TM] FFPE System has unlocked valuable, high-quality biological data in our large archive of samples," said Johnathan M. Lancaster, M.D., Ph.D., chief, Division of Gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology.  Surgical Oncology surgical oncology Oncological surgery The field of surgery dedicated to the operative ablation of neoplasia, generally, 'solid' tumors  at the H. Moffitt Cancer Center & Research Institute, who participated in Beta trials of the WT-Ovation[TM] FFPE System. "This is a significant advancement in our cancer exploration, as it enables us to study low-abundance transcripts in severely degraded RNA--something we've previously been unable to accomplish. We're impressed with the product's sensitivity and reproducibility in such a simple process. We hope that success with this system will enable us to rapidly translate FFPE-based genomic signatures into clinical tools that will help guide therapy for women with gynecologic cancer gynecologic cancer Gynecology Any malignancy of the ♀ reproductive tract, including cervix, endometrium, fallopian tubes, ovaries, uterus, vagina and, for some the breast ."

NuGEN will begin accepting orders for the WT-Ovation[TM] FFPE System on April 18th and will begin shipping the product in late May. Researchers may now process valuable samples using the Ovation[TM]/GeneChip([R]) pairing through Expression Analysis Inc. of North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures


Area, 52,586 sq mi (136,198 sq km). Pop.
, an authorized service provider An Authorized Service Provider (ASP) is a third party person that has been cleared to work on a product that is still under warranty by another company without voiding the warranty.  for both NuGEN and Affymetrix.

For pricing and availability of the WT-Ovation[TM] FFPE System (Cat.# 3400) and the FL-Ovation[TM] cDNA Biotin Module V2 (Cat.# 4200), please contact NuGEN Technologies at 888-654-6544 or custserv@nugeninc.com, or visit the NuGEN website at www.nugeninc.com.

About NuGEN Technologies

NuGEN Technologies is focused on the development and commercialization of sensitive, rapid and cost-effective amplification and labeling systems for genomic research. The company's technologies enable the comprehensive analysis and discovery of biological mechanisms, cellular responses and disease pathologies. NuGEN's proprietary SPIA SPIA Single Premium Immediate Annuity
SPIA School of Public and International Affairs (Virginia Tech)
SPIA Standards Profile for Imagery Access
SPIA Small Payload Interface Adapter
SPIA Scanner Power Interface Assembly
[TM] and Ribo-SPIA[TM] amplification and labeling system for DNA- and RNA-based applications form the foundation for a wide range of methods and products used by life scientists. The Ovation[TM] amplification and labeling system, the company's first commercially available product line, has applied these technologies to enhancing the sensitivity, convenience and accuracy of gene expression analysis. Based in San Carlos, Calif., NuGEN has a world-class investor syndicate, several collaborations with leading academic and commercial organizations and a management team with significant experience developing and marketing products for research or clinical diagnostic applications.

Note: NuGEN, Ovation, SPIA, Ribo-SPIA, WT-Ovation, FL-Ovation and Imagine More From Less are trademarks or service marks of NuGEN Technologies. All other marks are the property of their respective owners.

About Expression Analysis

Expression Analysis (www.expressionanalysis.com) is the industry's leading provider of microarray-based genomic services for clinical trials, specializing in gene expression and genotyping assays on multiple platforms and systems. The company is an authorized service provider for Affymetrix GeneChip([R]) microarrays and the NuGEN Ovation[TM] system amplification and labeling solutions.

About Affymetrix

Affymetrix GeneChip([R]) microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.

Today, 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 1,500 systems have been shipped around the world and more than 8,500 peer-reviewed papers have been published using the technology.

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit the company's website at www.affymetrix.com.

Forward-looking Statements

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 and uncertainties associated with the success of the collaboration with NuGEN Technologies discussed in this press release; risks of the company's ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
; uncertainties relating to technological approaches, manufacturing and product development; 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
. These and other risk factors are discussed in Affymetrix' Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2006, and other SEC reports, including its Quarterly Reports on Form 10-Q Form 10-Q

See 10-Q.
 for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking 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[R] are registered trademarks owned or used by Affymetrix Inc.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Clinical report
Date:Apr 17, 2007
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