FDA OKs Revvity’s Total Testosterone Assay

Revvity, through its subsidiary Immunodiagnostic Systems (IDS), has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA).

This complements the company’s FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG). According to Revvity, it delivers a first of its kind, complete solution for testosterone-related disorders on one platform.

The comprehensive portfolio allows direct ChLIA measurements of total testosterone, SHBG, and free testosterone, offering first- and second-line diagnostic testing capabilities for suspected hypogonadism in men. It’s processed on IDS’ random-access automation platforms and allows for single platform testing and replacement of equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS) methods.

These methods require complex technologies and calculations with operational and reproducibility challenges. Revvity’s immunoassay significantly streamlines workflow without compromising accuracy and reliability.

“Adding the total testosterone assay to our automated ChLIA platform transforms the offering to a wholly integrated solution that supports diagnostic testing for androgen-related conditions in both men and women,” said Arvind Kothandaraman, vice president and general manager, Euroimmun North America. “This clearance demonstrates our commitment to continued expansion of our portfolio to aid in the timely diagnosis of endocrine disorders.”

Other FDA-cleared assays in the company’s reproductive endocrine disorders portfolio include 17-OH progesterone (17-OHP), androstenedione and prolactin.

In November 2025, Revvity launched its Living Image Synergy AI multimodal analysis software for in vivo imaging researchers. The solution provides a unified platform with artificial intelligence (AI) capabilities for seamless data analysis across optical, microCT, ultrasound, and other modalities.