EUROIMMUN US announces that its automated chemiluminescence-based immunoassay (ChLIA) test has received FDA clearance for direct quantitative measurement of free testosterone levels, enabling diagnostic capabilities for androgen disorders. The assay features rapid results on EUROIMMUN’s ChLIA platforms with the first result available in 48 minutes and an estimated throughput of nearly 60 tests per hour. Able to incorporate monoclonal antibodies to ensure specificity and consistent performance across test batches, it can be operated with minimal technician training and expertise. The assay provides direct measurement of free testosterone levels in a single test, aiming to enhance diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.