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The Endocrine Society and CDC Collaborate to Standardize Testosterone Assays for Clinical Practice
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June 5, 2007 Contact: Aaron Lohr, Manager, Media Relations Toronto, Canada—A workshop at ENDO 07, The Endocrine Society’s 89th Annual Meeting, marks the beginning of a new collaboration between the Society and the Centers for Disease Control and Prevention (CDC) to establish standards and standardized methods to validate the performance of laboratory assays of serum testosterone (T) levels. Widely used assay methods to measure T levels suffer from a lack of accuracy and sensitivity, making it difficult for physicians to appropriately diagnose and treat androgen-related disorders in women, children, and men. To address the severely limited utility of these tests, The Endocrine Society issued a position statement in February 2007 that emphasized the need for standardizing and validating the methods by which serum T is measured. This new collaboration addresses that need. The workshop, Testosterone Assays in Practice: Addressing the Problems and Approaching Solutions, will take place on Tuesday, June 5 from 12:15 – 1 p.m. in room 104C/D at the Metro Toronto Convention Centre. The workshop will be chaired by Dr. William Rosner, professor of medicine, Columbia University College of Physicians and Surgeons, New York City, and member of the Society’s Androgen Assay Working Group, which studied the accuracy of the assays and prepared the Society’s statement. Also speaking at the workshop will be Dr. Hershel Raff of the Medical College of Wisconsin and Dr. Hubert Vesper from CDC. “There are serious problems with sensitivity and accuracy in testosterone assays, which need to be as accurate and reproducible as possible,” said Dr. Rosner. “The diagnosis and management of many serious medical conditions for women and men will depend to a large degree on highly accurate testosterone measurements.” As part of the collaboration, the Society will focus on the clinical aspects of establishing valid reference ranges and determining the level of accuracy and precision required by the medical community to ensure valid classification of patients into normal or disease states. CDC will focus on assessing the performance of labs that perform T assays, developing reference materials and guidelines, and identifying repositories for the materials and methods. CDC’s work is supported through a partnership with the CDC Foundation and Solvay Pharmaceuticals, Inc. Testosterone is the primary male sex hormone, but it may also fulfill important functions in women and children, including helping to maintain bone and muscle mass throughout life. In men, insufficient testosterone levels (hypogonadism) have been linked to obesity, low libido, and other serious medical conditions. Other members of the Society’s Androgen Assay Working Group include Dr. Richard J. Auchus, division of endocrinology and metabolism, University of Texas Southwestern Medical Center, Dallas; Dr. Ricardo Azziz, center for androgen related disorders and department of obstetrics/gynecology, Cedars-Sinai Medical Center, and department of obstetrics-gynecology and department of medicine, The David Geffen School of Medicine, University of California, Los Angeles; and Dr. Patrick M. Sluss, reproductive endocrinology unit and department of pathology, Massachusetts General Hospital, Boston. # # # The Endocrine Society's position statement was published in the February 2007 issue of The Journal of Clinical Endocrinology & Metabolism. Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.
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