Beckman Coulter Receives FDA Clearance to Market Automated Testosterone Test.

Business Editors and Health/Medical Writers

FULLERTON, Calif.--(BW HealthWire)--Nov. 20, 2000

Beckman Coulter, Inc. (NYSE:BEC) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Access(R) Testosterone, a new test for the quantitative determination of total testosterone levels in human serum and plasma.

Available on the company's Access Immunoassay System, a fully automated, random-access instrument with full stat capability, Access Testosterone is designed to assist in the management of patients with fertility disorders, sexual dysfunction, tumors or other medical conditions.

The test is the 34th assay to be cleared or approved by the FDA for use on the Access system, which performs cardiac, cancer, anemia, thyroid, infectious disease and other endocrine and reproductive tests.

Intended for use by commercial laboratories, hospitals, and endocrinology and fertility clinics, Access Testosterone quickly and reliably measures testosterone levels, helping to improve patient outcomes and lower overall healthcare costs. Test results can be generated in as little as 16 minutes and the assay can detect testosterone levels as low as .01 ng/mL.

"Our testosterone assay is among the most sensitive and reliable tests in the industry and is designed to provide physicians with the information they need to make important treatment decisions for their patients," said Jim Rigo, Beckman Coulter marketing manager, immunodiagnostics. "With the addition of Access Testosterone, we now have a full panel of reproductive tests on our Access system to aid doctors in the diagnosis and management of a wide range of medical conditions."

The production of testosterone -- a steroid hormone -- occurs naturally in both men and women. Testosterone helps build muscle, influences sex drive and stimulates production of red blood cells, which carry oxygen throughout the body.

In men, abnormal levels of testosterone may be a symptom of deficient production of pituitary hormones -- which influence growth, metabolism and maturation -- or Kleinfelter's syndrome, a chromosomal anomaly characterized by the presence of two X chromosomes and one Y chromosome, resulting in infertility. Irregular levels of testosterone can also indicate disease of the liver or kidneys.

In women, abnormal levels may be a sign of ovarian or adrenal tumors or polycystic ovarian disease (PCOD), a medical condition that results in irregular menstrual cycles, small cysts on the ovaries and infertility. High levels of testosterone also have been linked to the development of cancer in the endometrium, the lining of the uterus.

Beckman Coulter, headquartered in Fullerton, Calif., is a leading provider of instrument systems and complementary products that simplify and automate processes in life science and clinical laboratories. The company's products are used throughout the world in all phases of the battle against disease, from pioneering medical research and drug discovery to diagnostic testing that aids in patient treatment. Annual sales for the company totaled $1.8 billion in 1999, with approximately half of this amount generated outside the United States. More information on the company is available at www.beckmancoulter.com.