FDA awards clearance to Revvity’s total testosterone assay
Revvity, Inc. has received FDA clearance for its Total Testosterone chemiluminescence immunoassay, offering a comprehensive testing platform for testosterone-related disorders, streamlining diagnosis and replacing complex traditional methods.
The U.S. Food and Drug Administration (FDA) has granted clearance to Revvity, Inc., through its subsidiary, Immunodiagnostic Systems (IDS) for its Total Testosterone automated chemiluminescence immunoassay (ChLIA).
This offering complements the Company’s FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG), delivering a first of its kind, complete solution for testosterone-related disorders on a single platform.
This comprehensive portfolio enables direct ChLIA measurements of total testosterone, SHBG, and free testosterone, providing first- and second-line diagnostic testing capabilities for suspected hypogonadism in men. Processed on IDS’ random-access automation platforms, the expanded portfolio allows for single platform testing and replacement of equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS) methods that require complex technologies and calculations with operational and reproducibility challenges.
