FDA-Cleared Assay Streamlines Testosterone Testing

Revvity, Inc., through its subsidiary, Immunodiagnostic Systems (IDS), has announced that it received clearance from the U.S. Food and Drug Administration (FDA) 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, thereby significantly streamlining 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.”

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