FDA-Cleared Assay Enables Comprehensive Automated Testosterone Testing

Reference methods such as equilibrium dialysis with liquid chromatography/mass spectrometry can be operationally complex, rely on calculations, and present reproducibility challenges. A newly cleared assay now adds total testosterone to a platform that already measures free testosterone and sex hormone‑binding globulin, enabling a single‑platform workflow.

Revvity, through its subsidiary Immunodiagnostic Systems (IDS), received U.S. Food and Drug Administration (FDA) clearance on May 13, 2026, for the Total Testosterone automated chemiluminescence immunoassay (ChLIA). Together with the company’s FDA‑cleared ChLIA tests for free testosterone and sex hormone‑binding globulin (SHBG), the addition delivers the only FDA‑cleared ChLIA testosterone testing portfolio with direct measurement of all three analytes. The combined menu is positioned to support comprehensive assessment of testosterone‑related disorders on a single platform.

The portfolio enables direct ChLIA measurement of total testosterone, SHBG, and free testosterone, providing first‑ and second‑line diagnostic testing capabilities for suspected hypogonadism in men. All assays run on IDS random‑access automation platforms, allowing laboratories to consolidate testing without batching constraints. By replacing equilibrium dialysis–liquid chromatography/mass spectrometry (ED‑LC/MS) methods that require complex technologies and calculations and can present operational and reproducibility challenges, the workflow is significantly streamlined without compromising accuracy and reliability.

The clearance also expands Revvity’s broader endocrinology offering. Additional FDA‑cleared assays in the company’s reproductive endocrine disorders portfolio include 17‑OH progesterone (17‑OHP), androstenedione, and prolactin. Together, these tests are designed to simplify clinical workflows on a single automated platform.

“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.”