N-geneous Automated HDL Cholesterol Test Launched in the U.S.
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N-geneous Automated HDL Cholesterol Test Launched in the U.S.

CAMBRIDGE, Mass., Oct. 17, 1996 -- The diagnostic products unit of Genzyme Corp.'s General Division (Nasdaq: GENZ) announced today that it has begun marketing its N-geneous(TM) HDL cholesterol test in the United States.

The product launch follows clearance to market the test by the U.S. Food and Drug Administration's Center for Devices and Radiological Health.

The new test, which is being distributed by Genzyme under a worldwide agreement with the manufacturer of the test, Daiichi Pure Chemicals Co., Ltd., of Tokyo, measures how much high-density lipoprotein cholesterol is present in a patient's serum. It is simpler than other HDL cholesterol tests currently on the market because it eliminates the need to pretreat patient samples manually.

Instead, N-geneous HDL can be conducted completely on an automated clinical chemistry analyzer. The automation of HDL testing with N-geneous HDL will provide labs with significant operational benefits while at the same time enabling them to improve results by reducing the probability of error introduced by sample handling and manual sample pretreatment.

The N-geneous HDL test is being marketed as a replacement for current HDL cholesterol tests, which are often run in conjunction with total cholesterol testing. Genzyme estimates the U.S. market for the N-geneous HDL test to be between 50 and 100 million tests per year. Genzyme has been marketing N-geneous HDL in Europe and the rest of the world, with the exception of Asia, since June.

High levels of HDL cholesterol, also known as "good" cholesterol, have been shown to be beneficial in preventing heart disease. The N-geneous HDL test complements the Direct LDL(TM) test currently manufactured and marketed by Genzyme to measure how much low-density lipoprotein (LDL) cholesterol is in a patient's serum. People with high LDL cholesterol levels, also known as "bad" cholesterol, are at greater risk for developing heart disease.

One of the world's top five biotechnology companies, Genzyme focuses on developing innovative products and services for major unmet medical needs. The company's General Division develops and markets pharmaceuticals, genetic diagnostic services, and diagnostic, surgical, and specialty therapeutic products.

This press release contains forward-looking information, including an estimate of the potential market size for the N-geneous HDL cholesterol test. Actual results may differ materially depending on the accuracy of the company's information about competitive products.

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