WALTHAM, Mass., May 13, 2026
Revvity, Inc. has received U.S. FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding the company’s endocrinology diagnostics portfolio and enabling what it describes as the first FDA-cleared automated testosterone testing solution capable of directly measuring total testosterone, free testosterone, and sex hormone-binding globulin (SHBG) on a single platform. The regulatory milestone strengthens Revvity’s position in the growing field of automated endocrine diagnostics and laboratory workflow optimization.
Comprehensive Hormone Testing on a Single Platform
The newly cleared assay complements Revvity’s existing FDA-cleared ChLIA tests for free testosterone and SHBG, creating a complete automated testing portfolio for evaluating testosterone-related disorders. The integrated platform is designed to support first- and second-line diagnostic testing for conditions such as hypogonadism in men and androgen-related disorders affecting both men and women. By enabling direct measurements through a fully automated system, the platform aims to simplify clinical laboratory operations while improving testing consistency and efficiency.
According to the company, the expanded offering operates on IDS random-access automation platforms and can replace more complex traditional methods such as equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS), which often require advanced technologies, manual calculations, and highly specialized workflows. The simplified automated approach is expected to help diagnostic laboratories reduce operational complexity while maintaining high levels of accuracy and reproducibility.
FDA Clearance Expands Endocrinology Diagnostics Portfolio
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Revvity stated that the FDA clearance reflects its continued investment in endocrine and reproductive health diagnostics. The company’s broader reproductive endocrine disorders portfolio already includes FDA-cleared assays for 17-OH progesterone (17-OHP), androstenedione, and prolactin, supporting clinicians and laboratories involved in hormone disorder diagnosis and monitoring.
Arvind Kothandaraman, Vice President and General Manager of Euroimmun North America, noted that adding the total testosterone assay transforms the company’s automated ChLIA platform into a fully integrated diagnostic solution for androgen-related conditions. He emphasized that the clearance demonstrates Revvity’s commitment to expanding diagnostic capabilities that support the timely detection and management of endocrine disorders.
Growing Demand for Automated Clinical Diagnostics
The FDA clearance comes amid increasing global demand for automated clinical diagnostic systems capable of improving laboratory productivity and reducing turnaround times. Testosterone testing has become increasingly important in diagnosing metabolic, endocrine, fertility, and age-related hormonal disorders. Clinical laboratories are seeking technologies that can deliver reliable hormone measurements without the workflow burdens associated with traditional mass spectrometry-based methods.
Revvity continues to expand its healthcare and diagnostics footprint globally through innovations in translational multi-omics technologies, biomarker identification, imaging, screening, and advanced laboratory informatics. The company reported 2025 revenue of $2.9 billion and serves customers across pharmaceutical, biotech, diagnostic laboratory, academic, and government sectors in more than 160 countries worldwide.
The latest FDA clearance positions Revvity to strengthen its role in the evolving endocrinology diagnostics market, particularly as healthcare providers and laboratories increasingly prioritize automation, workflow efficiency, and precision hormone testing for improved patient care outcomes.
Source: Revvity press release
