Automated Free Testosterone Test Advances Diagnostic Capabilities for Androgen Disorders

Revvity, Inc. (Waltham, MA, USA) has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s (Lübeck, Germany) automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This groundbreaking test is the first of its kind to receive FDA approval for the direct quantitative measurement of free testosterone levels, marking a major step forward in diagnosing androgen disorders. The advanced assay operates on the company’s random-access iSYSTM or i10TM instruments, offering quick turnaround times and high throughput testing with minimal technician training required, while ensuring exceptional accuracy and reliability.

This FDA-cleared ChLIA assay provides rapid results for the direct quantitative measurement of free testosterone in human serum or plasma. The first result is available in just 48 minutes, with an estimated throughput of nearly 60 tests per hour on EUROIMMUN’s ChLIA platforms. The use of monoclonal antibodies guarantees specificity and consistent performance across test batches.

"Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone," said Jonathan Friend, general manager at Revvity’s EUROIMMUN US. "This clearance reinforces our commitment to expanding the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics.”