Revvity Launches Innovative FDA-Cleared Testosterone Test
WALTHAM, Mass. — Revvity, Inc. (NYSE: RVTY), has achieved a significant milestone with the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EUROIMMUN automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This groundbreaking test is notable as the first of its kind to secure FDA approval for the direct quantitative measurement of free testosterone levels, heralding a remarkable advancement in the diagnostics of androgen disorders.
Key Features of the FDA-Cleared Test
With an array of innovative features, the new test stands out in the market:
Exclusive FDA-Cleared Assay
It is the only FDA-cleared ChLIA assay designed specifically for the direct quantification of free testosterone in human serum or plasma. This exclusive status highlights the significance of the test in clinical settings, allowing healthcare professionals to obtain precise results swiftly.
Fast Results with High Throughput
Offering rapid results, the test operates on EUROIMMUN’s advanced ChLIA platforms, producing the first result in as little as 48 minutes. The system supports an estimated throughput of nearly 60 tests per hour, demonstrating an efficient solution for laboratories handling large volumes of testing.
Enhanced Specificity and Performance
The assay incorporates monoclonal antibodies, ensuring high specificity and consistent performance across different test batches. This technological advancement enhances the reliability of test results, providing healthcare providers with crucial data for diagnosis and treatment.
Streamlined Process on Advanced Instruments
Designed to be processed on the Company’s iSYS™ or i10™ instruments, the assay delivers quick turnaround times alongside high-throughput testing capabilities. The user-friendly system requires minimal technician training while ensuring superior accuracy and reliability. It allows for direct measurement of free testosterone levels using a single test, greatly enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.
Commitment to Diagnostic Solutions
Jonathan Friend, general manager at Revvity’s EUROIMMUN US, expressed excitement over this innovative achievement. "Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone," said Friend. "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."
About Revvity
Revvity is dedicated to transforming healthcare solutions, driven by a culture of innovation where “impossible” serves as inspiration, and “can’t be done” is seen as a call to action. The company offers a range of health science solutions including technologies, expertise, and services that cover complete workflows from discovery to development, through diagnosis to treatment. Revvity is revolutionizing possibilities in healthcare with a specific focus on translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection, diagnosis, and informatics.
With a remarkable revenue of over $2.7 billion in recent years and a dedicated team of more than 11,000 employees, Revvity serves a diverse customer base across pharmaceutical and biotech sectors, diagnostic laboratories, educational institutions, and governmental bodies. As a respected member of the S&P 500 index, Revvity maintains a global presence with customers in over 190 countries.
Frequently Asked Questions
What is the significance of Revvity's FDA clearance?
The clearance indicates the test is a medically validated solution for accurately measuring free testosterone levels, which is essential for diagnosing hormone-related disorders.
How quickly can results be obtained from the new test?
The test can produce the first results within just 48 minutes, providing timely data for clinical decisions.
What conditions can this test help diagnose?
The test is vital for diagnosing conditions such as hypogonadism, impotence, and polycystic ovarian syndrome (PCOS).
What technology does Revvity utilize in their testing?
Revvity employs advanced automated chemiluminescence immunoassay technology for its testing processes.
How does Revvity emphasize innovation?
Revvity is focused on redefining healthcare capabilities through innovative technologies and comprehensive solutions, positioning itself as a leader in health science advancements.
