Quanterix Corporation, has announced that the New York State Department of Health has given its Quanterix Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category. This approval expands the company’s work in advanced biomarker research and enhances its partnerships with clinical, pharmaceutical, and research organizations. Now, the Quanterix Accelerator Laboratory is fully CLIA certified across all 50 states, allowing it to perform comprehensive clinical testing and biomarker analysis throughout the country.
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“Every groundbreaking therapy and clinical trial starts with strong partnerships. Getting this permit shows our dedication to quality and compliance and allows us to share our expertise with a wider network of clinical and research partners,” said Masoud Toloue PhD, Chief Executive Officer of Quanterix.
The facility uses ultra-sensitive Simoa technology to provide exceptional precision in detecting protein biomarkers and supports biopharmaceutical research, clinical testing, and custom assay development. Operating under CLIA regulations, the lab has developed more than 100 custom assays and has supported over 264 global clinical trials in fields like neurology, immunology/oncology, and infectious diseases.
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It also offers fast results and dedicated project management to speed up discovery and therapeutic innovation. This permit is another important step in the lab’s growth and highlights Quanterix’s commitment to accuracy, reliability, and safety.
New York’s clinical testing standards are some of the strictest in the nation, and obtaining lab approval meant meeting the requirements of its Clinical Laboratory Evaluation Program. As part of the permit, the lab’s Simoa NfL Laboratory Developed Test received approval. The Quanterix Accelerator Laboratory also now offers advanced serum and plasma biomarker testing under the Lucent Diagnostics brand, combining the Accelerator Lab’s high standards and ultra-sensitive Simoa technology with Lucent Diagnostics’ focus on providing meaningful clinical insights and expanding biomarker-driven discovery and diagnostics to a broader clinical and research community.
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