Revvity Announces FDA Clearance for First Automated Free Testosterone Test
Revvity (NYSE: RVTY) has received FDA 510(k) clearance for EUROIMMUN's automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This marks a significant milestone as the first FDA-cleared test for direct quantitative measurement of free testosterone levels in human serum or plasma.
The innovative assay, which runs on the company's iSYSTM or i10TM instruments, delivers results in just 48 minutes with a throughput of nearly 60 tests per hour. The test features monoclonal antibodies for consistent performance and specificity across batches.
This advancement enhances diagnostic capabilities for conditions including hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes, offering a user-friendly, random-access platform solution for direct free testosterone measurement.
Revvity (NYSE: RVTY) ha ricevuto l'approvazione 510(k) della FDA per il test immunologico automatizzato basato su chemiluminescenza (ChLIA) di EUROIMMUN per il testosterone libero. Questo rappresenta una tappa significativa come il primo test approvato dalla FDA per la misurazione quantitativa diretta dei livelli di testosterone libero nel siero o nel plasma umano.
Il test innovativo, che utilizza gli strumenti iSYSTM o i10TM dell'azienda, fornisce risultati in soli 48 minuti con un throughput di quasi 60 test all'ora. Il test è caratterizzato da anticorpi monoclonali per prestazioni e specificità costanti tra i vari lotti.
Questo progresso migliora le capacità diagnostiche per condizioni come ipogonadismo, impotenza, sindrome dell'ovaio policistico (PCOS) e altre sindromi androgenitali, offrendo una soluzione di piattaforma accessibile e user-friendly per la misurazione diretta del testosterone libero.
Revvity (NYSE: RVTY) ha recibido la autorización 510(k) de la FDA para el ensayo inmunológico automatizado basado en quimioluminiscencia (ChLIA) de EUROIMMUN para el testosterona libre. Este es un hito significativo al ser la primera prueba autorizada por la FDA para la medición cuantitativa directa de los niveles de testosterona libre en suero humano o plasma.
El ensayo innovador, que funciona en los instrumentos iSYSTM o i10TM de la empresa, proporciona resultados en solo 48 minutos con un rendimiento cercano a 60 pruebas por hora. La prueba cuenta con anticuerpos monoclonales para un rendimiento y especificidad consistentes en los lotes.
Este avance mejora las capacidades diagnósticas para condiciones como hipogonadismo, impotencia, síndrome de ovario poliquístico (SOP) y otros síndromes androgenitales, ofreciendo una solución de plataforma de acceso aleatorio fácil de usar para la medición directa de la testosterona libre.
Revvity (NYSE: RVTY)는 EUROIMMUN의 화학발광 기반 면역 분석(ChLIA) 테스트에 대해 FDA 510(k) 승인을 받았습니다. 이는 인간 혈청 또는 혈장에서 자유 테스토스테론 수치를 직접 정량적으로 측정할 수 있는 첫 번째 FDA 승인 테스트로서 중요한 이정표입니다.
이 혁신적인 분석은 회사의 iSYSTM 또는 i10TM 장비에서 작동하며, 단 48분 만에 결과를 제공하고 시간당 거의 60개의 테스트를 처리할 수 있습니다. 이 테스트는 일관된 성능과 배치 간의 특이를 위한 단클론 항체를 특징으로 합니다.
이 발전은 저환상증, 발기부전, 다낭성 난소 증후군(PCOS) 및 기타 안드로겐성 질환과 같은 상태에 대한 진단 능력을 향상시키며, 자유 테스토스테론 측정을 위한 사용자 친화적이고 무작위 접근 플랫폼 솔루션을 제공합니다.
Revvity (NYSE: RVTY) a reçu l'autorisation 510(k) de la FDA pour le test immunologique automatisé basé sur la chimioluminescence (ChLIA) d'EUROIMMUN pour le testostérone libre. Cela marque une étape significative en tant que premier test approuvé par la FDA pour la mesure quantitative directe des niveaux de testostérone libre dans le sérum ou le plasma humain.
Le test innovant, qui fonctionne sur les instruments iSYSTM ou i10TM de l'entreprise, fournit des résultats en seulement 48 minutes avec un débit de près de 60 tests par heure. Le test présente des anticorps monoclonaux pour une performance et une spécificité constantes à travers les lots.
Cette avancée améliore les capacités diagnostiques pour des conditions telles que hypogonadisme, impuissance, syndrome des ovaires polykystiques (SOP) et d'autres syndromes androgénitaux, offrant une solution de plateforme d'accès aléatoire facile à utiliser pour la mesure directe de la testostérone libre.
Revvity (NYSE: RVTY) hat die FDA 510(k)-Zulassung für den automatisierten chemilumineszenzbasierten Immunassay (ChLIA) von EUROIMMUN zur Bestimmung von freier Testosteron erhalten. Dies stellt einen bedeutenden Meilenstein dar, da es sich um den ersten von der FDA zugelassenen Test zur direkten quantitativen Messung der freien Testosteronspiegel im menschlichen Serum oder Plasma handelt.
Der innovative Test, der auf den Instrumenten iSYSTM oder i10TM des Unternehmens läuft, liefert Ergebnisse in nur 48 Minuten mit einer Durchsatzrate von fast 60 Tests pro Stunde. Der Test nutzt monoklonale Antikörper für eine konsistente Leistung und Spezifität über verschiedene Chargen hinweg.
Dieser Fortschritt verbessert die diagnostischen Möglichkeiten für Erkrankungen wie Hypogonadismus, Impotenz, polyzystisches Ovarialsyndrom (PCOS) und andere androgenitale Syndrome und bietet eine benutzerfreundliche, zufällige Zugangsplattformlösung zur direkten Messung von freiem Testosteron.
- First FDA-cleared automated test for direct quantitative measurement of free testosterone
- High efficiency with 48-minute initial results and 60 tests per hour throughput
- Enhanced diagnostic capabilities for multiple conditions
- Superior accuracy and reliability with minimal training requirements
- None.
Insights
The FDA clearance of Revvity's automated free testosterone test represents a groundbreaking development in endocrine diagnostics. The direct measurement capability eliminates the need for complex calculations and estimations previously required, potentially reducing diagnostic errors and improving patient care. The test's 48-minute turnaround time and 60 tests per hour throughput could revolutionize laboratory workflows, particularly beneficial for high-volume clinical settings.
The technology's application extends beyond basic hormone testing - it's particularly valuable for diagnosing and monitoring complex endocrine disorders like PCOS, which affects up to 15% of reproductive-age women. The monoclonal antibody-based approach ensures consistent results across batches, addressing a long-standing challenge in hormone testing reliability. This precision could significantly impact treatment decisions and patient outcomes.
In simple terms: Imagine upgrading from a manual calculator to a smartphone - that's the leap this test represents in hormone testing. It's faster, more accurate and removes human error from the equation.
This FDA clearance positions Revvity strategically in the $3.6 billion global hormone testing market. Being first-to-market with an automated free testosterone test creates a significant competitive advantage and potential market leadership position. The random-access platform design and minimal training requirements lower the barrier to adoption for laboratories, potentially accelerating market penetration.
The timing is particularly advantageous given the growing focus on personalized medicine and the increasing prevalence of hormone-related disorders. The test's ability to serve diverse patient populations expands the addressable market significantly. For context - the demand for testosterone testing is growing at approximately 8.5% annually, driven by aging populations and increased awareness of hormone-related conditions.
Think of this as securing prime real estate in a rapidly growing neighborhood - Revvity has just claimed the best spot in a market that's only getting more valuable.
Key features of the new test include:
- The only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma.
- Rapid results on EUROIMMUN’s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per hour.
- Incorporation of monoclonal antibodies to ensure specificity and consistent performance across test batches.
The state-of-the-art assay is processed on the Company’s random-access iSYSTM or i10 TM instruments to deliver quick turnaround times and high-throughput testing with minimal technician training and expertise, while maintaining superior accuracy and reliability. The assay provides direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.
"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.”
For more information about EUROIMMUN and its diagnostic solutions, please visit this webpage.
About Revvity
At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise, and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.
With 2023 revenue of more than
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Investor Relations:
Steve Willoughby
steve.willoughby@revvity.com
Media Relations:
Chet Murray
(781) 462-5126
chet.murray@revvity.com
Source: Revvity
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