Revvity’s Free Testosterone Test Gains FDA Clearance, Fortifies Androgen Disorder Diagnostics

Revvity, Inc. has achieved an important milestone with the first-ever FDA-cleared automated test for the direct measurement of free testosterone levels in human serum or plasma. Utilizing a chemiluminescence-based immunoassay (ChLIA) — a technique that employs light-emitting chemical reactions to detect and measure substances in the body — the test sets a new standard in diagnostic precision for androgen-related disorders.

Its design incorporates monoclonal antibodies (mAbs) to ensure specificity and batch-to-batch consistency. Each test delivers rapid results in just 48 minutes, with platforms capable of processing up to 60 samples per hour — making it a powerhouse for busy labs. This efficient setup could support high-throughput workflows while maintaining accuracy.

Free testosterone, a key hormone involved in muscle growth, bone density and reproductive health, has been challenging to measure with precision.

Traditional methods often relied on indirect calculations that introduced variability. Revvity’s newly cleared test directly quantifies free testosterone, enhancing diagnostic consistency.

Compatible with EUROIMMUN’s automated platforms, the test simplifies lab operations and reduces training requirements, making it accessible for a range of healthcare settings, from large hospitals to specialized diagnostic centers, catering to diverse patient needs.

The test addresses diagnostic needs for conditions such as hypogonadism, polycystic ovarian syndrome (PCOS) and androgenital syndromes — complex disorders that impact everything from metabolic health to sexual function.

Revvity’s leadership sees this clearance as part of their broader efforts to expand diagnostic capabilities. They plan to continue developing solutions that improve diagnostic precision and efficiency for diverse patient populations.

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Why Revvity’s Free Testosterone Test Stands Out

Accurate measurement of free testosterone is essential because it represents the biologically active form of the hormone, which is more closely associated with clinical symptoms than total testosterone.

Existing methods often rely on calculated estimates influenced by sex hormone-binding globulin (SHBG) — a protein that binds testosterone in the blood and is often affected by factors such as aging, obesity and health conditions — leading to variable results.

Among current methods, which also include saliva-based assays and other commercial lab tests such as those offered by Quest Diagnostics and Labcorp, Revvity’s test is the first to directly measure free testosterone with FDA clearance, ensuring greater accuracy and reliability.

With rapid results, high throughput and compatibility with automated platforms, the test represents a more efficient and scalable solution, addressing gaps in diagnostic precision for androgen-related disorders.