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Genzyme Laboratory Recognized for Quality


Date: December 9, 2009

First Commercial Genetic Testing Facility to Achieve Accreditation From College of American Pathologists


Genzyme Corporation (NASDAQ: GENZ) announced today that its genetic testing laboratory located in Phoenix, Arizona, has obtained the CAP 15189SM Accreditation to the International Standards Organization 15189:2007 Standard for laboratories from the College of American Pathologists. This accreditation recognizes the laboratory’s technical competence and continual quality management and underscores Genzyme’s commitment to improved patient outcomes by providing reliable test results.

The College of American Pathologists offers laboratories the opportunity to be measured against the quality standards outlined by the International Organization of Standardization. The College of American Pathologists rigorously assessed Genzyme’s quality management systems over the course of a full year before awarding it the CAP 15189 designation.

“Achieving this accreditation demonstrates our commitment to achieving superior quality standards and delivering overall operational excellence,” said Jon Hart, senior vice president and general manager of Genzyme Genetics, the business unit of Genzyme Corporation focused on complex testing services for pathology, oncology, reproductive and genetic medicine. “Going through the rigorous and extensive accreditation process has allowed us to mitigate risk and continually provide highly accurate test results to physicians and patients nationwide.”

“Although the 15189 Standard is not currently mandated in the United States, CAP believes that laboratories that strive to be in the top tenth percentile in quality will benefit from seeking this standard and the College is proud to make it available to American laboratories,” said Cordelia Sever, MD, FCAP, chair of the CAP 15189 Committee.

Genzyme expects to pursue CAP 15189 accreditation in all of its genetic testing laboratories located throughout the United States.

About CAP 15189

CAP 15189 is a voluntary, non-regulatory accreditation to the ISO 15189:2007 Standard as published by the International Organization of Standardization. This program does not replace the CAP’s CLIA-based Laboratory Accreditation Program, but complements CAP accreditation and other quality systems. This program optimizes processes to improve patient care, strengthen quality standards while reducing institutional errors and risks, and controls costs. CAP 15189 is an educational program that offers a highly disciplined approach to implementing and sustaining change.

About CAP

The College of American Pathologists (CAP) is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of board certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective patient care. For additional information on the CAP 15189 Program, e-mail CAP15189@cap.org

About Genzyme Genetics

Genzyme Genetics is driven by its commitment to patients and offers a broad array of testing services for pathology, oncology, reproductive and genetic medicine. Over twenty-five years of testing expertise utilizing sophisticated technologies has made Genzyme Genetics a leading provider of high-quality testing services for physicians and their patients. With an extensive network of laboratories across the United States, Genzyme Genetics assists thousands of clinicians in providing the best care possible to patients. As a division of Genzyme Corporation, Genzyme Genetics contributes its resources and strengths to one of the world’s leading biotechnology companies. For more information, please visit www.genzymegenetics.com

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

CAP 15189SM is a service mark of the College of American Pathologists.

Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.




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