Revvity Expands Endocrine Diagnostics After FDA Clearance for Total Testosterone Assay
Revvity Expands Endocrine Diagnostics After FDA Clearance for Total Testosterone Assay
Revvity Inc. has strengthened its endocrine diagnostics portfolio after receiving U.S. Food and Drug Administration clearance for its Total Testosterone automated chemiluminescence immunoassay, also known as ChLIA. The clearance was announced on May 13, 2026, through Revvityâs subsidiary Immunodiagnostic Systems, or IDS.
FDA Clearance Marks a Key Step for Revvityâs Diagnostics Business
The newly cleared assay is designed to measure total testosterone and is intended to support testing for testosterone-related and androgen-related conditions. It adds to Revvityâs already FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin, commonly called SHBG. Together, these tests create an automated portfolio that can measure total testosterone, free testosterone, and SHBG on a single platform.
This development is important for clinical laboratories because testosterone evaluation often requires more than one marker. Physicians may need total testosterone, free testosterone, and SHBG results to better understand a patientâs hormonal status. By bringing these tests together through one automated workflow, Revvity aims to make endocrine testing more efficient and easier to manage.
Why the Total Testosterone Assay Matters
Total testosterone testing is commonly used in the evaluation of suspected hypogonadism in men and other androgen-related conditions in both men and women. Revvity said the expanded testing menu provides first-line and second-line diagnostic capabilities for suspected hypogonadism.
The companyâs assay runs on IDS random-access automation platforms. This means laboratories can process tests more flexibly instead of relying on more complex testing workflows. According to Revvity, the platform may reduce the need for equilibrium dialysis-liquid chromatography/mass spectrometry methods, which can require more complex technologies, calculations, and operational handling.
A More Complete Automated Testosterone Testing Portfolio
Revvity describes the expanded ChLIA testosterone testing portfolio as the only FDA-cleared ChLIA portfolio that directly measures total testosterone, free testosterone, and SHBG. This positions the company more strongly in the endocrine diagnostics market, especially as laboratories continue looking for automated solutions that can improve turnaround times and reduce workflow complexity.
The clearance also builds on Revvityâs earlier progress in reproductive and endocrine diagnostics. In January 2025, the company received FDA clearance for an automated free testosterone ChLIA test, which Revvity described as the first FDA-cleared automated ChLIA test for direct quantitative measurement of free testosterone in serum or plasma.
Company Leadership Highlights Broader Clinical Use
Arvind Kothandaraman, vice president and general manager of Euroimmun North America, said the addition of the total testosterone assay turns the automated ChLIA platform into a more integrated solution for androgen-related diagnostic testing in both men and women. He also said the clearance reflects Revvityâs continued effort to expand its portfolio for timely diagnosis of endocrine disorders.
Potential Impact on Laboratories and Patients
For laboratories, the key benefit is workflow consolidation. Instead of using several methods or platforms, labs may be able to perform related hormone tests through one automated system. This can help reduce manual steps, support consistency, and improve operational efficiency.
For healthcare providers, access to a broader automated testing menu may support faster and more organized decision-making. While test results must always be interpreted by qualified medical professionals, more streamlined diagnostics can help support care for patients being evaluated for endocrine or androgen-related disorders.
Revvityâs Position in Specialty Diagnostics
The FDA clearance gives Revvity another way to expand its presence in specialty diagnostics. The company operates across life sciences and diagnostics, and this announcement shows its focus on building practical laboratory tools for complex clinical areas such as endocrinology.
By combining total testosterone, free testosterone, and SHBG testing in one automated portfolio, Revvity is aiming to meet demand from laboratories that need reliable, efficient, and scalable testing options. The move also supports the companyâs broader strategy of expanding its automated immunodiagnostics menu.
Conclusion
Revvityâs FDA-cleared Total Testosterone ChLIA assay represents a meaningful expansion of the companyâs endocrine diagnostics offering. The clearance allows Revvity to offer a more complete automated testosterone testing solution that includes total testosterone, free testosterone, and SHBG.
As laboratories face pressure to improve speed, accuracy, and efficiency, automated platforms like IDSâ random-access systems may become more valuable. For Revvity, the approval strengthens its diagnostics portfolio and reinforces its role in the growing field of endocrine and reproductive health testing.
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