FDA Approves Revvity's Automated Latent Tuberculosis Test, Enhancing Diagnostic Efficiency
核心洞察
The FDA has approved Revvity (搜索)'s Auto-Pure 2400 (搜索) liquid handling platform with the T-SPOT.TB (搜索) test, offering laboratories higher throughput capabilities for latent tuberculosis (搜索) detection without compromising clinical accuracy.
The automated system can process up to 24 samples per run and completes the first day of testing in under 3.5 hours with minimal user interaction, significantly streamlining laboratory workflows.
As the only ELISPOT-based IGRA identified by the WHO, the T-SPOT.TB (搜索) test delivers fewer indeterminate results, reduced repeat testing needs, and consistent performance in immunocompromised patients.
Revvity (搜索), Inc. (NYSE: RVTY) announced that the U.S. Food and Drug Administration (FDA) has approved its Auto-Pure 2400 (搜索) liquid handling platform with the T-SPOT.TB (搜索) test for latent tuberculosis (搜索) (TB) detection. This approval represents a significant advancement in TB diagnostics, providing laboratories with a high-throughput automated solution that maintains superior clinical performance.
The system, which was initially launched outside the U.S. in 2024, combines advanced liquid handling with magnetic cell isolation technology to deliver faster and more reliable results for latent TB (搜索) infection, a condition affecting approximately one-quarter of the global population.
"The integration of the Auto-Pure 2400 (搜索) platform with the T-SPOT.TB (搜索) test gives laboratories the ability to process latent TB (搜索) tests at higher volumes without compromising clinical accuracy," said Yves Dubaquie, senior vice president, diagnostics at Revvity (搜索). "By automating T-SPOT.TB testing, we are empowering laboratories with increased throughput and reliability, ultimately leading to better patient outcomes."
Technical Capabilities and Clinical Advantages
The Auto-Pure 2400 (搜索) system significantly enhances laboratory efficiency by processing up to 24 samples per run and completing the first day of T-SPOT.TB (搜索) testing in under 3.5 hours with only a single mid-run user interaction. This automation addresses the growing demand for TB testing while reducing manual handling errors and improving standardization.
The World Health Organization (WHO) recognizes T-SPOT.TB (搜索) as the only ELISPOT-based Interferon-Gamma Release Assay (IGRA). This methodology incorporates a cell number normalization step that ensures reproducible results by minimizing the impact of pre-analytical variables commonly seen in other IGRAs.
The test offers several clinical advantages that are particularly valuable in TB management:
- Fewer indeterminate results, reducing diagnostic uncertainty
- Decreased need for repeat testing, saving time and resources
- Consistent performance in immunocompromised patients, a population where TB detection is often challenging
Global TB Burden and Diagnostic Challenges
Tuberculosis (搜索) remains one of the world's deadliest infectious diseases, with an estimated 10 million new cases annually. Latent TB (搜索) infection, where individuals harbor the bacteria without showing symptoms, affects approximately 1.7 billion people globally—roughly one-quarter of the world's population.
Early and accurate detection of latent TB (搜索) is crucial for preventing progression to active disease and reducing transmission. However, traditional diagnostic methods have limitations in throughput, accuracy, and performance in certain patient populations.
The approval of this automated system addresses these challenges by providing a scalable solution that maintains high clinical standards while increasing testing capacity—a critical factor in high-burden settings and screening programs.
Market Impact and Availability
The FDA approval allows Revvity (搜索) to market the Auto-Pure 2400 (搜索) platform with the T-SPOT.TB (搜索) test in the United States, expanding its global footprint. The company notes that the product may not be licensed in all countries, and customers should check with local representatives for availability.
Revvity (搜索), with 2024 revenue exceeding $2.7 billion and approximately 11,000 employees, serves customers across pharmaceutical and biotech sectors, diagnostic laboratories, academia, and governments in more than 160 countries. The company is part of the S&P 500 index and focuses on delivering diagnostic solutions, translational multi-omics, biomarker discovery, imaging, screening, and informatics.
This approval strengthens Revvity (搜索)'s position in the infectious disease diagnostics market while contributing to global efforts to control tuberculosis (搜索) through improved detection capabilities.