We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

LabMedica

Download Mobile App
Recent News Expo
ADLM 2025
Clinical Chem. Molecular Diagnostics Hematology Immunology Microbiology Pathology Technology Industry Focus

Automated Free Testosterone Test Advances Diagnostic Capabilities for Androgen Disorders

By LabMedica International staff writers
Posted on 17 Jan 2025

A state-of-the-art assay offers direct measurement of free testosterone levels in a single test, significantly improving diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgen-related disorders.

Revvity, Inc. (Waltham, MA, USA) has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s (Lübeck, Germany) automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This groundbreaking test is the first of its kind to receive FDA approval for the direct quantitative measurement of free testosterone levels, marking a major step forward in diagnosing androgen disorders. The advanced assay operates on the company’s random-access iSYSTM or i10TM instruments, offering quick turnaround times and high throughput testing with minimal technician training required, while ensuring exceptional accuracy and reliability.


Image: The state-of-the-art assay is processed the random-access iSYSTM or i10 TM instruments (Photo courtesy of EUROIMMUN)
Image: The state-of-the-art assay is processed the random-access iSYSTM or i10 TM instruments (Photo courtesy of EUROIMMUN)

This FDA-cleared ChLIA assay provides rapid results for the direct quantitative measurement of free testosterone in human serum or plasma. The first result is available in just 48 minutes, with an estimated throughput of nearly 60 tests per hour on EUROIMMUN’s ChLIA platforms. The use of monoclonal antibodies guarantees specificity and consistent performance across test batches.

"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.”


Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
Serological Pipet Controller
PIPETBOY GENIUS
New
Urine Chemistry Control
Dropper Urine Chemistry Control
New
Specimen Radiography System
TrueView 200 Pro

Latest Molecular Diagnostics News

First Blood-Based Test Measures Key Alzheimer's Biomarker in Asymptomatic and Symptomatic Individuals
17 Jan 2025  |   Molecular Diagnostics

Rapid Molecular Diagnostic Device to Detect and Differentiate Ebola and Marburg Virus Species
17 Jan 2025  |   Molecular Diagnostics

New RNA-Based Measure Predicts Mortality Risk and Tracks Aging
17 Jan 2025  |   Molecular Diagnostics



PURITAN MEDICAL