The CLIA-certified facility is now authorized to operate in all 50 states, expanding biomarker testing capabilities nationwide.
Quanterix Corporation has received a clinical laboratory permit from the New York State Department of Health for its Accelerator Laboratory in the Clinical Chemistry category, the company announced.
The permit enables the Billerica, Massachusetts-based company to expand its ultrasensitive biomarker detection services to one of the nation’s largest healthcare markets. The Quanterix Accelerator Laboratory is now fully CLIA-certified in all 50 states.
“Collaboration is at the core of the Quanterix Accelerator Laboratory,” says Masoud Toloue, PhD, chief executive officer of Quanterix, in a release. “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.”
Meeting New York’s Clinical Testing Standards
New York’s clinical testing standards are among the most stringent in the country, according to a release from the company, requiring laboratories to meet Clinical Laboratory Evaluation Program standards. The permit approval allows Quanterix to serve clinical, pharmaceutical, and research partners in the state.
As part of the laboratory permitting process, the Accelerator’s Simoa NfL Laboratory Developed Test gained approval. The company plans to seek authorization for additional clinical tests to expand its available test menu.
The Quanterix Accelerator Laboratory uses ultrasensitive Simoa technology for protein biomarker detection, supporting biopharmaceutical research, clinical testing, and custom assay development. The facility has developed more than 100 custom assays and supported over 264 global clinical trials across neurology, immunology/oncology, and infectious diseases.
Lucent Diagnostics Integration
Under the Quanterix Accelerator Laboratory operations, 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 ultrasensitive Simoa technology with Lucent Diagnostics’ clinical insights delivery.
Quanterix’s Simoa technology enables detection and quantification of biomarkers in blood and other fluids at concentrations below traditional detection limits. The company reports more than 3,600 peer-reviewed publications using its technology over nearly two decades.
In 2025, Quanterix acquired Akoya Biosciences, adding multiplexed tissue imaging capabilities with single-cell resolution to its portfolio and 1,396 installed instruments. The combined company offers a platform connecting biology across blood and tissue applications.
