Revvity Secures FDA Approval for Improved Automated Latent Tuberculosis Test

FDA approves leading solution for latent tuberculosis diagnostics, advancing global effort to fight infectious diseases

WALTHAM, Mass.--(BUSINESS WIRE)-- Revvity, Inc. (NYSE: RVTY), today announced that the U.S. Food and Drug Administration (FDA) has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT™.TB test. Initially launched outside the U.S. in 2024, this powerful combination allows laboratories to improve productivity while maintaining superior clinical performance in latent tuberculosis (TB) detection. This milestone marks a significant advancement in the fight against TB with a faster high-throughput solution delivering accurate diagnostic results to support timely treatment and containment in the U.S. as well as other locations around the world.

“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.

With 2024 revenue of more than $2.7 billion and approximately 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 160 countries.

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Source: Revvity