Revvity Secures FDA Approval for Improved Automated Latent Tuberculosis Test

Business Wire
04-02

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

WALTHAM, Mass., April 02, 2025--(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.

For In Vitro Diagnostic Use. Products may not be licensed in accordance with the laws in all countries. Please check with your local representative for availability.

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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Contacts

Investor Relations:
Steve Willoughby
steve.willoughby@revvity.com

Media Contact:
Chet Murray
(781) 462-5126
chet.murray@revvity.com






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