Quanterix Accelerator Laboratory Receives New York State Clinical Laboratory Permit, Enhancing Research and Testing Capabilities.

Quanterix's Accelerator Laboratory has secured a New York State clinical laboratory permit, enhancing its research and testing capabilities nationwide. The lab is now fully CLIA-certified across all 50 states, enabling comprehensive clinical testing and biomarker analysis. The permit underscores the company's commitment to quality and compliance, supporting advanced biopharmaceutical research and clinical trials.

Quanterix Corporation (NASDAQ: QTRX), a leader in ultra-sensitive biomarker detection, has secured a significant milestone with the New York State Department of Health (NYSDOH) granting its Quanterix Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category. This permit approval expands the lab's advanced biomarker research capabilities and underscores the company's commitment to accuracy, reliability, and scientific excellence.

The Quanterix Accelerator Laboratory is now fully CLIA-certified in all 50 states, enabling comprehensive clinical testing and biomarker analysis nationwide. This certification allows the lab to deliver unmatched precision in protein biomarker detection, supporting biopharmaceutical research, clinical testing, and custom assay development.

The permit approval is the latest in a series of growth milestones for the lab, which has developed over 100 custom assays and supported more than 264 global clinical trials across various fields, including neurology, immunology/oncology, and infectious diseases. The lab's Simoa® NfL Laboratory Developed Test (LDT) gained approval as part of the laboratory permitting, with plans to authorize additional clinical tests to further broaden the available test menu.

The integration of the Lucent Diagnostics brand under the Quanterix Accelerator Laboratory provides advanced serum and plasma biomarker testing to the clinical and research community. This integration combines the lab's rigor and ultra-sensitive Simoa® technology with Lucent Diagnostics' focus on delivering actionable clinical insights, expanding the reach and impact of biomarker-driven discovery and diagnostics.

The New York State clinical testing standards are among the most comprehensive in the country, requiring labs to meet rigorous Clinical Laboratory Evaluation Program (CLEP) standards. Securing this permit reaffirms Quanterix's commitment to quality and compliance, enabling the company to extend its expertise to a broader network of clinical and research partners.

Quanterix, with its proprietary Simoa® technology, has been a trusted partner to the scientific community for nearly two decades, with more than 3,600 peer-reviewed publications. In 2025, the company acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics.

References:
[1] https://www.morningstar.com/news/business-wire/20250821115585/quanterix-accelerator-laboratory-awarded-rigorous-new-york-state-clinical-laboratory-permit
[2] https://ir.quanterix.com/news-releases/news-release-details/quanterix-accelerator-laboratory-awarded-rigorous-new-york-state