Revvity has secured US regulatory clearance for a major expansion in endocrine diagnostics, strengthening its push into automated hormone testing.
The company announced that it has received clearance from the U.S. Food and Drug Administration for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), developed through its subsidiary Immunodiagnostic Systems (IDS).
The approval completes a broader testosterone testing suite already including free testosterone and sex hormone-binding globulin (SHBG), creating what the company describes as a fully integrated diagnostic platform.
The system is designed to run total testosterone, free testosterone, and SHBG on a single automated platform, enabling streamlined diagnosis of suspected hypogonadism and other androgen-related disorders.
It also positions the company’s ChLIA portfolio as an alternative to more complex laboratory methods such as equilibrium dialysis and LC/MS workflows, which require specialized infrastructure and manual processing.
“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.”
With the latest clearance, Revvity now offers one of the most complete FDA-cleared automated endocrine testing menus in the reproductive hormone space, including assays for 17-OH progesterone, androstenedione, and prolactin.
The company, which reported $2.9 billion in 2025 revenue and operates in more than 160 countries, continues to expand its diagnostics footprint across laboratories, biotech, and clinical research markets.
