Abbott (NYSE: ABT) announced today CE Marking (Conformite Europeenne) for a testosterone assay with improved sensitivity and clinical utility. With a simple blood test, the ARCHITECT 2nd Generation Testosterone Assay can accurately measure the wide range of testosterone levels seen in a number of different patient populations and clinical settings.
Testosterone assays play an important role in the diagnosis and management of many medical conditions in men, women, and children. However, published studies have shown that many currently available testosterone assays are not sensitive enough to measure low levels of testosterone. This limits the clinical utility of these assays and can result in suboptimal patient care. For this reason, in 2010, the Endocrine Society published a consensus statement calling for improved testosterone assays and noted that the availability of highly accurate testosterone assays would result "in improved diagnosis, treatment, and prevention of disease."
"Our recent hands-on experience with the ARCHITECT 2nd Generation Testosterone Assay indicates that it allows reliable and reproducible assessment of testosterone in patients suspected to have low circulating testosterone levels. This may be beneficial for patients and their doctors as well as for the laboratory," said Dr. Rien Blankenstein, professor and chairman, Department of Clinical Chemistry, VU University Medical Center, Amsterdam.