Revvity has received clearance from the US Food and Drug Administration (FDA) for its total testosterone automated chemiluminescence immunoassay (ChLIA) via its Immunodiagnostic Systems (IDS) subsidiary.
This addition further supports Revvity’s FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG), offering a fully integrated approach for testosterone-related disorder diagnostics on one platform.
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The new offering allows for direct ChLIA measurements of SHBG, total testosterone, and free testosterone, delivering key first- and second-line diagnostic capabilities in the identification of suspected hypogonadism in men.
The entire portfolio is processed on IDS’ random-access automation platforms, consolidating testing onto a single platform and eliminating the need for equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS) methods.
These legacy methods traditionally involve complex technologies, detailed calculations, and present challenges in operations and reproducibility.
By streamlining workflow and centralising diagnostics without compromising results, Revvity’s automated solution aims to ease operational hurdles for laboratories.
Revvity’s Euroimmun North America vice-president and general manager Arvind Kothandaraman said: “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.
“This clearance demonstrates our commitment to continued expansion of our portfolio to aid in the timely diagnosis of endocrine disorders.”
The company’s portfolio for reproductive endocrine disorders also features FDA-cleared assays for 17-OH progesterone (17-OHP), androstenedione and prolactin.
Revvity serves pharmaceutical and biotech sectors, diagnostic laboratories, academia, and governments and has customers in more than 160 countries.
In April 2025, the FDA granted its approval for Revvity’s Auto-Pure 2400 liquid handling platform, used in conjunction with the T-SPOT.TB test.
