Revvity Wins FDA Clearance for Total Testosterone Test — Expanding Clinical Infrastructure for Hormone Health
Revvity has received FDA clearance for a diagnostic system capable of running both total and free testosterone — strengthening the clinical testing infrastructure that underpins the growing testosterone health market.
Editor
5/20/20261 min read
Revvity has won FDA clearance for a total testosterone testing system. The system is designed to run total testosterone and free testosterone assessments, giving clinical laboratories a cleared diagnostic tool for comprehensive hormone measurement. The clearance was reported by Indian Pharma Post.
Revvity operates across the life sciences and diagnostics space, offering instruments and systems used in clinical laboratories for a range of testing applications. Its testosterone testing system targets the clinical laboratory market, providing a platform for measuring hormone levels with regulatory backing from the US Food and Drug Administration.
The FDA clearance applies to a system designed specifically for running total and free testosterone — two of the primary biomarkers used in testosterone replacement therapy (TRT) assessments and broader male hormone health evaluations. The clearance enables clinical sites to adopt the system within a regulatory-compliant framework.
The timing is significant: as TRT adoption continues to accelerate across telehealth and in-person clinic settings, the clinical testing pipeline that supports diagnosis, monitoring, and dosage management becomes a critical dependency. FDA-cleared testosterone testing systems underpin the credibility of the entire hormone health sector, making regulatory milestones like Revvity's clearance a meaningful infrastructure development for the men's health market.