About Genzyme Genetics

Genzyme Genetics is a leading worldwide provider of reproductive and oncology diagnostic testing, as well as genetic counseling services. As a business unit of Genzyme Corporation, Genzyme Genetics employs over 1,500 people and has eight laboratories located across the United States and operations in Europe and Japan.

Extensive Test Menu

Genzyme Genetics leadership is evidenced by its state-of-the-art menu of reproductive testing services. We offer innovative products such as CFplus^™, an extensive cystic fibrosis carrier screening test that addresses the needs of the pan-ethnic U.S. population, and an industry-leading menu of maternal serum screening tests designed to provide the critical information to pregnant patients as early and accurately as possible in their pregnancy.

Additionally, we have extensive testing experience in the areas of breast cancer, colorectal cancer, hematolymphoid and difficult-to-diagnose cases. The company leads the market in breast cancer therapeutic and prognostic analysis, providing critical information on over 20% of newly diagnosed breast cancer cases in the United States, and in hematology/oncology testing services, seeing 20% of newly-diagnosed cases of suspected leukemia and lymphoma in the U.S. annually.

Sophisticated Testing

Genzyme Genetics employs a variety of sophisticated testing methods, including:

• Biochemistry: A screening technique using biochemical markers in a pregnant woman's serum (blood) to assess the risk for chromosome abnormalities and open neural tube defects in her fetus.
• Cytogenetics: A method to detect abnormalities in the number and structure of chromosomes.
• Drug Resistance Assay (DRA^™): A technology that assesses the resistance of tumor cells to specific drugs.
• Flow Cytometry: A technique to quantify and classify different types of blood cells.
• Fluorescence In Situ Hybridization (FISH): A technique using fluorescently tagged DNA probes to characterize chromosome abnormalities and rearrangements.
• Immunohistochemistry (IHC): A technique for identifying cellular or tissue constituents, so called antigens, by means of antigen-antibody interactions.
• Molecular Genetics: A DNA-based analysis to detect known mutations of genes.

Genetic Counseling

Our commitment to high quality diagnostic testing is accompanied by an equally rigorous dedication to first-class prenatal genetic counseling services. For that reason, Genzyme Genetics employs over 140 board certified genetic counselors who interpret results for physicians and patients. This represents the largest network of genetic counselors in the country.

Our genetic counselors assess prenatal genetic risks for individual patients, and explain the benefits, risks and limitations of genetic testing. We also offer an extensive array of medical educational programs to health care professionals regarding current standards of testing and the issues presented by it.

Medical and Technical Expertise

Our staff of more than 75 academic and community-trained physicians and scientists has extensive industry experience. Using both traditional and cutting-edge technologies, they review every case and are also available around the clock to offer brief or extended consultations as needed.

Our Approach to Quality

In the highly competitive market of clinical laboratory testing, simply complying with standard regulations is not enough. Our goals are to offer superior diagnostic testing and counseling today, to prepare for the future and to regularly exceed the expectations of our clients. Our holistic approach to quality focuses on customer satisfaction, exemplary laboratory and clinical practices and continual improvement processes.

In order to accomplish our goals, we have looked to many regulatory and guidance organizations, including CAP standards, state laboratory requirements, FDA Class I Medical Device Regulations, ASR Regulations, Baldridge Excellence, Six Sigma, and ISO 9000. As a result, our quality program is comprehensive, precise, relevant and results-driven.

Senior managers throughout our organization champion our quality program. Their commitment, matched daily by the active participation of all our employees, is what makes Genzyme Genetics the industry leader in providing quality diagnostic testing services.