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Affymetrix Clinical Services Laboratory and DOCRO Join Forces to Accelerate the Commercialization of In Vitro Diagnostic Products.


SANTA CLARA Santa Clara, city, Cuba
Santa Clara (sän`tä klä`rä), city (1994 est. pop. 217,000), capital of Villa Clara prov., central Cuba.
, Calif. -- Affymetrix Inc. (Nasdaq:AFFX) announced today that the Affymetrix Clinical Services Laboratory (ACSL ACSL Advanced Continuous Simulation Language (AEgis Technologies Group, Inc.)
ACSL American Computer Science League
ACSL Assistant Cub Scout Leader
ACSL Altocumulus Standing Lenticular Clouds (often confused for UFOs) 
) has signed a co-marketing agreement with DOCRO DOCRO Diagnostic Oncology Clinical Research Organization (Seymour, CT)  Inc., a leading contract research organization (CRO) that specializes in the commercialization of in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 diagnostic (IVD (Interactive VideoDisc) See interactive video. ) biomarker technologies. The two companies will work together to help customers gain clearance or approval of IVD products from the U.S. Food and Drug Administration (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 bring those products to market faster than before.

Over the past decade, there have been hundreds of microarray discoveries -- expression and genotyping -- with potential diagnostic implications. However, researchers have not had effective or efficient means to translate these discoveries into validated clinical diagnostic tests. With more than 80 FDA submissions, DOCRO is an experienced CRO that provides ACSL customers with a clear path and understanding of how to commercialize IVD products.

ACSL is a CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a  (Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. )-registered clinical testing laboratory that offers microarray-based molecular diagnostic send-out and clinical trial testing services to pharmaceutical companies, IVD companies and other laboratories. The co-marketing agreement with DOCRO provides ACSL customers with access to a full suite of validation and regulatory clinical trial services and resources. These include:

* protocol design

* patient recruitment

* clinical site training and monitoring

* clinical sample procurement

* predicate In programming, a statement that evaluates an expression and provides a true or false answer based on the condition of the data.  device testing

* guidance through the regulatory submission process

"DOCRO welcomes the opportunity to collaborate with Affymetrix through its CLIA laboratory, ACSL," said Thomas F. Soriano, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of DOCRO. "For the past 10 years, DOCRO has a proven formula for success that has led to an unparalleled track record with the FDA, making DOCRO the clear choice for FDA pre-market approvals. Together with Affymetrix, we can expedite the commercialization process of ACSL customers' products."

"We are very excited to work with the highly experienced and enthusiastic team at DOCRO," said Cynthia French, Ph.D., vice president of ACSL. "Together, we will enable our customers to bring more effective molecular diagnostic tests to patients faster than ever before."

About ACSL

ACSL is a CLIA-registered clinical testing laboratory that specializes in send-out and clinical trial testing services for gene expression monitoring, genotyping and chromosomal copy number analysis, as well as other molecular diagnostic tests. ACSL also prepares supporting documentation and offers training programs for customers looking to transfer the laboratory methods and apply validated protocols in their own regulated environments. ACSL is located in a 10,000-square-foot facility in West Sacramento, Calif.

For more information about the Affymetrix Clinical Services Laboratory, please send an email to diagnosticsales@affymetrix.com.

About DOCRO

DOCRO is headquartered in Seymour, Connecticut Seymour is a town located in western New Haven County,Connecticut, United States. The population was 15,454 at the 2000 census.

The town has a train station on the Waterbury Branch of the New Haven Line of the Metro-North Railroad.
, and has been servicing the IVD industry for more than 10 years. DOCRO is a specialty CRO that provides a full range of professional services (job) professional services - A department of a supplier providing consultancy and programming manpower for the supplier's products.  to biotechnology, therapeutic, pharmaceutical manufacturers and IVD manufacturers. DOCRO's services include strategic consulting, product development, specimen acquisition and regulatory consulting. DOCRO owns a CLIA-certified laboratory that offers a full suite of clinical trial testing services.

With more than half of the IVD pre-market approvals during the past decade, DOCRO has demonstrated its expertise and real-world experience in the development, clinical validation and market-making introduction of many of the then innovative, but now standard, diagnostic tests in the field of oncology. DOCRO has in-depth experience with a wide variety of protein-based and molecular biology-based diagnostic tests. Beyond its traditional core specialty of oncology diagnostics, DOCRO has worked extensively in the validation and regulatory submission process involving infectious diseases infectious diseases: see communicable diseases. , perinatal and prenatal disease, cardiology, endocrinology, metabolic diseases, obstetrics and gynecology obstetrics and gynecology

Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system.
, hematology/coagulation, transplant immunology, drugs of abuse, and other medical specialties. For more information about DOCRO, please visit the company's website at www.docro.com.

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 related to the agreement between Affymetrix and DOCRO 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 related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties related to sole-source suppliers; uncertainties related to FDA and other regulatory approvals; competition; risks related 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. DOCRO and the DOCRO logo are registered trademarks owned or used by DOCRO 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
Date:Jul 16, 2007
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