Revvity Receives FDA Clearance for Total Testosterone Assay Enabling Comprehensive Automated Testosterone Testing Solution

Original from: business news 

- Delivers the only FDA-cleared ChLIA testosterone testing portfolio with direct measurement of total testosterone, free testosterone, and sex hormone-binding globulin

- Simplifies clinical workflow on a single platform

- Expands the Company’s endocrinology portfolio and capabilities

Revvity, Inc., through its subsidiary, Immunodiagnostic Systems (IDS), today 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.”

Source: Revvity Receives FDA Clearance for Total Testosterone Assay Enabling Comprehensive Automated Testosterone Testing Solution