Revvity Wins FDA Nod for Automated Free Testosterone Test

Revvity has received U.S. Food and Drug Administration (FDA) 510(k) clearance for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone.

This is the first test of its kind, according to the company, to earn FDA clearance for direct quantitative measurement of free testosterone levels. It marks a major advance in diagnostic capabilities for androgen disorders.

Rapid results on EUROIMMUN’s ChLIA platforms produce results in 48 minutes with estimated throughput of almost 60 tests an hour. The test incorporates monoclonal antibodies to ensure specificity and consistent performance across test batches.

The assay is processed on the company’s random-access iSYSTM or i10 TM instruments for quick turnaround times and high-throughput testing with minimal technician training and expertise, while maintaining accuracy and reliability. The assay offers direct measurement of free testosterone levels in a single test, boosting diagnostic capabilities for conditions like hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.

“Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone,” said Jonathan Friend, general manager at Revvity’s EUROIMMUN US. “This clearance reinforces our commitment to expanding the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics.”