The FDA has granted clearance to Revvity’s automated chemiluminescence immunoassay (ChLIA) for total testosterone measurement.1 The assay is designed to support diagnostic testing for androgen-related disorders, including suspected hypogonadism.
The clearance adds to Revvity’s previously cleared ChLIA assays for free testosterone and sex hormone-binding globulin (SHBG), allowing laboratories to perform multiple testosterone-related measurements on a single 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 of Euroimmun North America, in the news release.1 “This clearance demonstrates our commitment to continued expansion of our portfolio to aid in the timely diagnosis of endocrine disorders.”
According to Revvity, the platform marks “the only FDA-cleared ChLIA testosterone testing portfolio with direct measurement of total testosterone, free testosterone, and sex hormone-binding globulin.” The company noted that the integrated workflow could reduce reliance on equilibrium dialysis–liquid chromatography/mass spectrometry (ED-LC/MS) methods, which remain widely regarded as reference methodologies for free testosterone assessment but are technically complex and less broadly available. Revvity emphasized that the automated platform is intended to streamline testing workflows while maintaining analytical reliability.
The assay is intended for use on the company’s IDS random-access automation platforms.
Additional Revvity platforms
The new clearance builds on the company’s earlier FDA authorization for its automated free testosterone ChLIA assay, which Revvity announced in January 2025.2 At that time, the company described the assay as the first FDA-cleared automated ChLIA test for direct quantitative measurement of free testosterone in serum or plasma. The assay was developed for use on the company’s iSYS and i10 platforms and can generate results in 48 minutes, with an estimated throughput of nearly 60 tests per hour.
In addition to testosterone-related assays, Revvity stated that its reproductive endocrinology testing portfolio includes FDA-cleared assays for 17-hydroxyprogesterone, androstenedione, and prolactin.
