CDC Foundation Announces $1.7 Million Grant to Improve and Standardize Testosterone Measurements in Laboratories Nationwide

The Centers for Disease Control and Prevention (CDC) Foundation today announced a $1.7 million grant from Solvay Pharmaceuticals, Inc. to improve and standardize hormone measurements, specifically testosterone, among laboratories nationwide. Results from the multi-year project, which involves scientists at CDC and Boston Medical Center (BMC), will help clinicians better diagnose and manage hormone-related diseases, such as hypogonadism in men.

“The extreme variability in hormone measurements that currently exists among laboratories makes it difficult to identify people at risk of hormone-related chronic diseases and conditions, to conduct research in these areas, and to apply important research findings in everyday clinical practice” said Hubert Vesper, Ph.D., a research chemist in CDC’s National Center for Environmental Health, Division of Laboratory Sciences. “We are eager to improve and standardize the state of hormone testing so doctors can better assess and manage hormone-related diseases like those caused by low testosterone levels.”

Low testosterone levels affect an estimated 13 million American men age 45 and older. Men with chronic conditions, such as obesity, diabetes and hypertension, are more likely to have low testosterone compared with other men. Symptoms may include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density. Because the symptoms associated with low testosterone can be nonspecific, physicians also rely on the measurement of testosterone levels in the blood to better assess the condition.

“Solvay Pharmaceuticals is proud to be a part of this initiative to help advance the medical community’s ability to diagnose and manage hypogonadism in men,” said Laurence Downey, M.D., president and CEO of Solvay Pharmaceuticals, Inc.

About the Testosterone Measurement Project

At the outset of the project, a working group consisting of members from the clinical, research and assay manufacturing communities will be established to collect information about the problems and potential solutions related to testosterone measurements and provide guidance throughout the span of this project.

The scientific team working on the project will:

• Assess current laboratory performance in testosterone measurements through inter-laboratory comparison studies in order to identify measurement problems.
• Develop a new, precise and accurate method for reliably measuring testosterone in people. This process will be led by the Clinical Chemistry Branch in the Division of Laboratory Sciences at CDC’s National Center for Environmental Health.
• Use this new method to create reference materials that laboratories nationwide can use to begin standardizing testosterone testing. The method and reference materials are the key components to successfully improving testosterone measurements over time.
• Measure samples from the Framingham Heart Study to determine reference ranges of testosterone in men (led by endocrinologist Shalender Bhasin, M.D., of BMC).
• Develop a reference laboratory that will assist other laboratories in improving accuracy and precision over time to minimize laboratory variability. CDC will seek to obtain certification as a reference laboratory from international accreditation bodies, such as the International Organization Standards and Joint Committee for Traceability in Laboratory Medicine.

“The CDC Foundation is excited about the potential of this project to help people better manage chronic health conditions and live healthier lives,” says Charles Stokes, president and CEO of the CDC Foundation. “We are grateful to Solvay Pharmaceuticals for helping CDC bring leaders in this field of research together to address this important issue.”