Free Testosterone Test: Revvity Receives FDA Clearance for First Automated Assay
Revvity, Inc. (NYSE: RVTY), a global leader in health science solutions, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This breakthrough marks the first FDA-cleared test designed for the direct quantitative measurement of free testosterone levels, representing a significant step forward in the diagnosis and management of androgen-related disorders.
The new test, developed by EUROIMMUN, a Revvity company, is set to enhance diagnostic capabilities for various conditions involving testosterone imbalances, including hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgen disorders. The FDA clearance is a testament to the innovation and accuracy of this assay, which delivers fast, reliable results on a widely used, random-access testing platform.
Key Features of the Test
The new automated free testosterone test offers a host of advanced features that set it apart from traditional testing methods. Notable highlights include:
- FDA-Cleared Assay for Direct Measurement: This is the only FDA-cleared ChLIA assay for the direct, quantitative measurement of free testosterone in human serum or plasma. The test is designed to address the growing demand for more precise diagnostic tools in the field of andrology.
- Rapid Results: The test delivers quick results, with the first result available in as little as 48 minutes. With an estimated throughput of nearly 60 tests per hour, this assay provides fast turnaround times, making it ideal for high-volume laboratories.
- Monoclonal Antibody Technology: The assay incorporates monoclonal antibodies, ensuring high specificity and consistent performance across test batches. This guarantees accurate and reliable results, even when testing large numbers of samples.
- High Throughput and User-Friendly: The test is processed on Revvity’s iSYSTM or i10™ instruments, both of which are part of the company’s random-access automation solutions. These instruments are designed to minimize technician training requirements while maintaining high throughput, with nearly 60 tests processed per hour, ensuring efficient laboratory workflows.
- Wide Application: The test is designed for the direct measurement of free testosterone levels in a single assay, offering improved diagnostic capabilities for a variety of medical conditions. These include hypogonadism, impotence, PCOS, and other androgen-related conditions, where accurate measurement of free testosterone levels is critical for effective diagnosis and treatment.
Jonathan Friend, General Manager at Revvity’s EUROIMMUN US, emphasized the significance of this breakthrough for laboratory customers: “Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone. 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.”
The development of this FDA-cleared test is a milestone in EUROIMMUN’s efforts to expand its diagnostic portfolio. By offering an easy-to-use, rapid-testing solution for free testosterone, the company aims to support healthcare providers in offering timely, accurate diagnoses for their patients.
Revvity’s Commitment to Healthcare Innovation
Revvity, a global powerhouse in health science technologies, continues to push the boundaries of what’s possible in healthcare. The company provides a comprehensive suite of solutions, technologies, and services spanning discovery, development, diagnosis, and treatment. Its offerings include advanced capabilities in multi-omics, biomarker identification, imaging, screening, detection, informatics, and more, all of which contribute to advancing healthcare and improving patient outcomes.
With over $2.7 billion in revenue for 2023 and a workforce of more than 11,000 employees worldwide, Revvity serves a wide range of industries, including pharmaceutical and biotech companies, diagnostic laboratories, academia, and government entities. The company operates in over 190 countries and is part of the prestigious S&P 500 index.
Revvity’s commitment to driving progress in healthcare is clear from its ongoing efforts to revolutionize diagnostics, including the launch of the free testosterone test. This test not only expands the company’s diagnostic offerings but also underscores Revvity’s focus on improving healthcare through innovative, efficient, and accessible solutions.
About Revvity
Revvity is a global leader in health science solutions, technologies, and services that span the entire lifecycle of healthcare. Specializing in translational research, biomarker identification, diagnostics, and more, Revvity is committed to improving patient outcomes through innovation. With over $2.7 billion in revenue and a global presence in more than 190 countries, Revvity continues to lead the charge in revolutionizing healthcare.
