FDA clears chemiluminescence-based immunoassay for free testosterone

The FDA has granted 510(k) clearance to EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for the quantitative measurement of free testosterone levels in serum or plasma, Revvity, Inc, announced in a news release.¹

The test also has European CE mark approval.

It the first test of its kind to receive FDA approval for the measurement of free testosterone, the company noted. The ChLIA test also has European CE mark approval.²

According to Revvity, the test can provide results in 48 minutes to provide diagnostic insights for conditions such as hypogonadism, impotence,polycystic ovarian syndrome, and other androgenital syndromes. The FDA clearance is for an assay range of 0.40 pg/mL to 60.00 pg/mL.³

The test is processed using the company’s iSYS or i10 instruments and incorporates highly specific monoclonal antibodies to ensure accurate and reproducible results. EUROIMMUN's ChLIA tests "use magnetic particles coated with antibodies or antigens as a solid phase to detect specific antigens or antibodies in patient samples by means of chemiluminescence signals," the company explained.⁴

"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, in the news release.¹ "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.”

This test adds to EUROIMMUN’s suite of reproductive testing options, which includes an automated assay for the quantitative measurement of total testosterone.⁵

The total testosterone test has been granted CE mark approval in Europe and can be used in the diagnosis and treatment of conditions such as primary and secondary hypogonadism, delayed or precocious puberty, impotence in males, hirsutism and virilization in females due to tumors, polycystic ovaries, and adrenogenital syndromes.The test has not been granted FDA clearance in the US.

References

1. Revvity announces FDA Clearance for first automated free testosterone test. News release. Published online and accessed January 10, 2025. https://news.revvity.com/press-announcements/press-releases/press-release-details/2025/Revvity-Announces-FDA-Clearance-for-First-Automated-Free-Testosterone-Test/default.aspx

2. Endocrine Reproductive. Immunodiagnosticssystems. Accessed January 10, 2025. https://www.idsplc.com/disease-areas/endocrinology/endocrine-reproductive/

3. Free testosterone. Immunodiagnosticssystems. Accessed January 10, 2025. https://www.idsplc.com/products/free-testosterone/

4. ChLIA. EUROIMMUN. Accessed January 10, 2025. https://www.euroimmun.us/techniques/chlia/

5. Total testosterone. Immunodiagnosticssystems. Accessed January 10, 2025. https://www.idsplc.com/products/total-testosterone/