Biomarkers

Quanterix Lab Earns New York State Clinical Testing Permit

Permit approval enables expanded research capabilities and underscores commitment to accuracy, reliability, and scientific excellence

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced the New York State Department of Health (NYSDOH) has granted the Quanterix Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category. The permit approval expands advanced biomarker research led by Quanterix, deepening collaborations with clinical, pharmaceutical, and research partners. The Quanterix Accelerator Lab is now fully CLIA-certified in all 50 states, enabling comprehensive clinical testing and biomarker analysis nationwide.

“Collaboration is at the core of the Quanterix Accelerator Laboratory,” said Masoud Toloue, PhD, Chief Executive Officer of Quanterix. “Every breakthrough therapy and clinical trial begins with strong partnerships. Securing this permit reaffirms our commitment to quality and compliance and enables us to extend our expertise to a broader network of clinical and research partners.”

The Quanterix Accelerator Laboratory is a cutting-edge facility leveraging ultra-sensitive Simoa® technology to deliver unmatched precision in protein biomarker detection, supporting biopharmaceutical research, clinical testing, and custom assay development. Certified under the Clinical Laboratory Improvement Amendments (CLIA) program, the Lab has developed 100+ custom assays and supported over 264 global clinical trials across neurology, immunology/oncology, and infectious diseases, combining rapid turnaround with dedicated project management to accelerate discovery and therapeutic innovation.

The latest achievement in a series of growth milestones for the Lab, the new permit underscores Quanterix’s commitment to meeting the highest benchmarks for accuracy, reliability, and safety. As one of the nation’s largest healthcare markets, New York’s clinical testing standards are among the most comprehensive in the country, requiring labs to meet rigorous Clinical Laboratory Evaluation Program (CLEP) standards.

Accelerator’s Simoa® NfL Laboratory Developed Test (LDT) gained approval as part of the laboratory permitting. Authorizations for additional clinical tests are planned to further broaden the available test menu.

Additionally, operating under the Quanterix Accelerator Laboratory, the Lucent Diagnostics brand now provides advanced serum and plasma biomarker testing to the clinical and research community. This integration combines the Accelerator 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.

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