Axis-Shield's testosterone test gains FDA approval:
This article was originally published in Clinica
Executive Summary
Anglo-Norwegian firm Axis-Shield has received FDA approval to market its testosterone assay in the US using Abbott Laboratories AxSYM range of laboratory analysers. Axis-Shield will manufacture the test at its Dundee, Scotland facilities, having launched the testosterone test in non-US markets earlier this year. Detecting abnormal levels of testosterone can help diagnose conditions such as infertility, pituitary disease, obesity, adrenal disease and polycystic ovary syndrome. Axis-Shield claims there are already 17,000 AxSYM analysers placed in hospitals and laboratories worldwide, and plans to extend its range of AxSYM-based assays under its agreement with Abbott.