Clearance of AXSYM Testosterone Test, Abbott Labs and Axis Shield

Main Category: Fertility
Article Date: 19 Oct 2004 - 11:00 PDT

Testosterone Testing Helps Doctors Investigate Sexual Dysfunction and Other Endocrine Disorders
Abbott Laboratories today announced that its manufacturing partner Axis-Shield received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a testosterone test designed for use on Abbott's widely-used AxSYM automated immunoassay instrument system. Testosterone is frequently measured to investigate sexual dysfunction and other endocrine disorders. In April, Abbott introduced the AxSYM Testosterone test in other major markets throughout the world and expects to start distributing the product in the United States within a few weeks.

"Sometimes used in combination with other diagnostic testing, a testosterone test can help diagnose several conditions and aid in the investigation of infertility in men. Delayed or early puberty, hypogonadism, excessive body hair or polycystic ovary syndrome in women can be the result of abnormal testosterone levels," said William F. Crowley, Jr., M.D., Director of the Harvard-wide Reproductive Endocrine Sciences Center and Professor of Medicine at Harvard Medical School.

Reliably detecting low testosterone levels in patients, the AxSYM testosterone test is sensitive, precise and provides initial results within 13 minutes. Since testosterone levels vary, typically higher in men than women, the ability of the test to accurately detect testosterone levels across a wide range helps improve patient diagnosis.

"When doctors investigate endocrine disorders, they often order a variety of tests. Not only will laboratories be able to supply testosterone results quickly, but with the AxSYM system, a lab can process additional fertility or other immunoassay tests at the same time," said Michael J. Collins, vice president, U.S. Diagnostic Commercial Operations, Abbott Laboratories. "The AxSYM testosterone test provides diagnostic laboratories with an accurate and sensitive test to measure low to high concentration levels of testosterone and is an excellent addition to AxSYM's fertility menu."

Other tests on the AxSYM fertility menu include: AxSYM® Estradiol, AxSYM® FSH [follicle stimulating hormone], AxSYM® LH [luteinizing hormone], AxSYM® Prolactin, and AxSYM® Total â-hCG [Beta human chorionic gonadotropin]. Outside of the United States, AxSYM® Progesterone is also available.

The AxSYM immunoassay system can process up to 80 to 120 tests per hour allowing medium-volume clinical laboratories to process a variety of immunodiagnostic tests simultaneously. Besides fertility, other test menus include assays for abused drugs, cancer, cardiac, endocrinology, hepatitis, infectious disease, metabolic/renal, therapeutic drug monitoring and toxicology.

About Axis-Shield

Axis-Shield is a global manufacturer of in vitro diagnostic kits with a focus on new markers in cardiovascular, rheumatoid, infectious and alcohol-related diseases, diabetes, dementia and near patient testing to facilitate improved patient management. Axis-Shield has partnered with Abbott to introduce several new tests on both the IMx and AxSYM systems, Abbott's market-leading automated immunoassay analyzers. News releases and company information are available athttp://www.axis-shield.com.

About Abbott Laboratories

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.

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