WALTHAM, Mass. — Revvity Inc. said it has received U.S. Food and Drug Administration clearance for its Total Testosterone automated chemiluminescence immunoassay, expanding the company’s testosterone testing portfolio.
The Waltham-based life sciences company said the clearance was received through its subsidiary Immunodiagnostic Systems. The assay complements Revvity’s FDA-cleared chemiluminescence immunoassay tests for free testosterone and sex hormone-binding globulin, or SHBG.
Revvity said the expanded offering provides a complete testosterone testing solution on a single automated platform. The company said the portfolio enables direct measurement of total testosterone, free testosterone and SHBG for use in first- and second-line diagnostic testing for suspected hypogonadism in men.
The tests are processed on IDS’ random-access automation platforms. Revvity said the system can simplify clinical workflow by allowing single-platform testing and by reducing reliance on equilibrium dialysis-liquid chromatography/mass spectrometry methods, which require more complex technologies and calculations.
The company said the expanded portfolio is designed to improve operational efficiency while maintaining 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.”
