Revvity Secures FDA Approval for Improved Automated Latent Tuberculosis Test
Revvity (NYSE: RVTY) has received FDA approval for its Auto-Pure 2400 liquid handling platform integrated with the T-SPOT.TB test for latent tuberculosis detection. The system, which was initially launched outside the U.S. in 2024, combines automation with high clinical accuracy in TB diagnostics.
The Auto-Pure 2400 platform features automated liquid handling and magnetic cell isolation technology, processing up to 24 samples per run and completing Day 1 testing in under 3.5 hours with minimal user interaction. The T-SPOT.TB test, recognized by WHO as the only ELISPOT-based IGRA, includes a cell number normalization step that ensures consistent results by reducing pre-analytical variables.
Key advantages include fewer indeterminate results, reduced repeat testing requirements, and reliable performance in immunocompromised patients.
Revvity (NYSE: RVTY) ha ricevuto l'approvazione della FDA per la sua piattaforma di gestione dei liquidi Auto-Pure 2400 integrata con il test T-SPOT.TB per la rilevazione della tubercolosi latente. Il sistema, lanciato inizialmente al di fuori degli Stati Uniti nel 2024, combina automazione con alta precisione clinica nella diagnostica della tubercolosi.
La piattaforma Auto-Pure 2400 dispone di tecnologia di gestione automatizzata dei liquidi e isolamento magnetico delle cellule, elaborando fino a 24 campioni per ciclo e completando il test del Giorno 1 in meno di 3,5 ore con interazione minima da parte dell'utente. Il test T-SPOT.TB, riconosciuto dall'OMS come l'unico IGRA basato su ELISPOT, include un passaggio di normalizzazione del numero di cellule che garantisce risultati coerenti riducendo le variabili pre-analitiche.
I principali vantaggi includono un numero ridotto di risultati indeterminati, minori requisiti di ripetizione dei test e prestazioni affidabili nei pazienti immunocompromessi.
Revvity (NYSE: RVTY) ha recibido la aprobación de la FDA para su plataforma de manejo de líquidos Auto-Pure 2400 integrada con la prueba T-SPOT.TB para la detección de tuberculosis latente. El sistema, que se lanzó inicialmente fuera de EE. UU. en 2024, combina automatización con alta precisión clínica en el diagnóstico de la tuberculosis.
La plataforma Auto-Pure 2400 cuenta con tecnología de manejo de líquidos automatizada y aislamiento magnético de células, procesando hasta 24 muestras por ejecución y completando la prueba del Día 1 en menos de 3.5 horas con mínima interacción del usuario. La prueba T-SPOT.TB, reconocida por la OMS como el único IGRA basado en ELISPOT, incluye un paso de normalización del número de células que asegura resultados consistentes al reducir las variables pre-analíticas.
Las principales ventajas incluyen menos resultados indeterminados, requisitos reducidos de pruebas repetidas y un rendimiento confiable en pacientes inmunocomprometidos.
Revvity (NYSE: RVTY)는 잠복 결핵 검사를 위한 T-SPOT.TB 테스트와 통합된 Auto-Pure 2400 액체 처리 플랫폼에 대해 FDA 승인을 받았습니다. 이 시스템은 2024년 미국 외 지역에서 처음 출시되었으며, 결핵 진단에서 높은 임상 정확성과 자동화를 결합합니다.
Auto-Pure 2400 플랫폼은 자동 액체 처리 및 자석 세포 분리 기술을 갖추고 있으며, 한 번의 실행에 최대 24개 샘플을 처리하고 사용자 상호작용을 최소화하여 3.5시간 이하에 첫날 테스트를 완료합니다. WHO에 의해 유일한 ELISPOT 기반 IGRA로 인정받은 T-SPOT.TB 테스트는 일관된 결과를 보장하기 위해 세포 수 정규화 단계를 포함하여 전 분석 변수를 줄입니다.
주요 장점으로는 불확실한 결과가 적고, 반복 테스트 요구가 줄어들며, 면역이 저하된 환자에서 신뢰할 수 있는 성능을 제공합니다.
Revvity (NYSE: RVTY) a reçu l'approbation de la FDA pour sa plateforme de gestion des liquides Auto-Pure 2400 intégrée au test T-SPOT.TB pour la détection de la tuberculose latente. Le système, lancé initialement en dehors des États-Unis en 2024, combine automatisation et haute précision clinique dans le diagnostic de la tuberculose.
La plateforme Auto-Pure 2400 dispose d'une technologie de gestion des liquides automatisée et d'isolement magnétique des cellules, traitant jusqu'à 24 échantillons par série et complétant le test du Jour 1 en moins de 3,5 heures avec une interaction minimale de l'utilisateur. Le test T-SPOT.TB, reconnu par l'OMS comme le seul IGRA basé sur ELISPOT, inclut une étape de normalisation du nombre de cellules qui garantit des résultats cohérents en réduisant les variables pré-analytiques.
Les principaux avantages comprennent moins de résultats indéterminés, des exigences réduites en matière de tests répétés et des performances fiables chez les patients immunodéprimés.
Revvity (NYSE: RVTY) hat die FDA-Zulassung für seine Auto-Pure 2400 Flüssigkeits-handhabungsplattform erhalten, die mit dem T-SPOT.TB-Test zur Erkennung latenter Tuberkulose integriert ist. Das System, das 2024 zunächst außerhalb der USA eingeführt wurde, kombiniert Automatisierung mit hoher klinischer Genauigkeit in der Tuberkulose-Diagnostik.
Die Auto-Pure 2400-Plattform verfügt über automatisierte Flüssigkeits-handhabung und magnetische Zellisolierungstechnologie und verarbeitet bis zu 24 Proben pro Durchgang und schließt den Test am Tag 1 in weniger als 3,5 Stunden mit minimaler Benutzerinteraktion ab. Der T-SPOT.TB-Test, der von der WHO als der einzige auf ELISPOT basierende IGRA anerkannt ist, umfasst einen Schritt zur Normalisierung der Zellzahl, der konsistente Ergebnisse gewährleistet, indem präanalytische Variablen reduziert werden.
Die wichtigsten Vorteile sind weniger unbestimmte Ergebnisse, reduzierte Anforderungen an Wiederholungstests und zuverlässige Leistung bei immungeschwächten Patienten.
- FDA approval secured for automated TB testing platform
- High-throughput capability: 24 samples per run with 3.5-hour completion time
- Superior clinical performance with fewer indeterminate results
- Effective in immunocompromised patients, reducing need for repeat testing
- None.
Insights
This FDA approval for Revvity's Auto-Pure 2400 platform with T-SPOT.TB test represents a significant advancement in latent tuberculosis diagnostics. The integration of liquid handling and magnetic cell isolation technology addresses key workflow challenges in clinical laboratories.
The system's ability to process 24 samples per run with completion in under 3.5 hours dramatically improves laboratory efficiency compared to conventional methods that typically require more manual intervention and longer processing times. Most importantly, this automation doesn't compromise clinical accuracy.
What's technically impressive is the cell number normalization step in the ELISPOT-based IGRA methodology, which the WHO uniquely recognizes. This feature substantially reduces pre-analytical variables that often plague other interferon-gamma release assays, resulting in fewer indeterminate results and reduced repeat testing—both significant cost and time factors in diagnostic laboratories.
The consistent performance in immunocompromised patients is particularly valuable, as these high-risk populations often present diagnostic challenges with traditional tuberculosis testing methods. This capability ensures more reliable detection in vulnerable groups where accurate diagnosis is most critical for treatment decisions.
The FDA approval of Revvity's Auto-Pure 2400 platform with T-SPOT.TB test unlocks the substantial U.S. market for this diagnostic solution previously only available internationally. This regulatory milestone comes at an opportune time as healthcare systems increasingly demand higher throughput solutions with reduced labor requirements.
The automation capabilities directly address the ongoing clinical laboratory staffing challenges, offering a compelling value proposition: higher productivity with minimal user intervention. Laboratories can realize operational efficiencies while maintaining diagnostic integrity, creating a strong adoption case for high-volume testing centers.
From a competitive standpoint, the WHO recognition of T-SPOT.TB as the only ELISPOT-based IGRA establishes a technical differentiation in the tuberculosis testing market. The reduced need for repeat testing translates to better economics for laboratory customers—fewer consumables, less labor, and improved turnaround times.
This approval strengthens Revvity's diagnostics portfolio with a solution that delivers both clinical and operational benefits. While tuberculosis might not grab headlines like other infectious diseases, it remains a global health priority with sustained testing demand, providing Revvity with an expanded market opportunity for this automated platform.
FDA approves leading solution for latent tuberculosis diagnostics, advancing global effort to fight infectious diseases
“The integration of the Auto-Pure 2400 platform with the T-SPOT.TB test gives laboratories the ability to process latent TB tests at higher volumes without compromising clinical accuracy,” said Yves Dubaquie, senior vice president, diagnostics at Revvity. “By automating T-SPOT.TB testing, we are empowering laboratories with increased throughput and reliability, ultimately leading to better patient outcomes.”
Key Features of the Automated Latent Tuberculosis Test
- The Auto-Pure 2400 system seamlessly integrates liquid handling and magnetic cell isolation technology.
- The Auto-Pure 2400 system streamlines lab workflows, testing up to 24 samples per run, completing Day 1 of the T-SPOT.TB testing in under 3.5 hours with only a single mid-run user interaction.
- The WHO identifies T-SPOT.TB as the only ELISPOT-based IGRA. This methodology, with its added cell number normalization step, ensures reproducible results by minimizing the impact of pre-analytical variables seen in other IGRAs.
- The T-SPOT.TB test delivers key advantages, including fewer indeterminate results, reduced need for repeat testing, and consistent performance in immunocompromised patients.
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About Revvity
At Revvity, we turn "impossible" into innovation and transform scientific challenges into breakthroughs. We deliver cutting-edge solutions in diagnostics, translational multi-omics, biomarker discovery, imaging, screening, and informatics—helping our customers move from research to real-world impact.
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Source: Revvity
FAQ
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