Quanterix Accelerator Laboratory Secures New York State Clinical Laboratory Permit, Expanding Biomarker Research and Clinical Testing Capabilities Nationwide
Quanterix Corporation (NASDAQ: QTRX), a biotechnology company recognized for revolutionizing precision medicine through its ultrasensitive biomarker detection platforms, today announced a major regulatory milestone: the New York State Department of Health (NYSDOH) has officially granted the Quanterix Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category.
This approval represents a significant expansion of the Lab’s authority to provide clinical testing services and strengthens its ability to support biopharmaceutical companies, clinical researchers, and healthcare providers. Importantly, the designation makes the Quanterix Accelerator Laboratory one of the few facilities with certification to conduct advanced biomarker testing under both the Clinical Laboratory Improvement Amendments (CLIA) program and New York State’s rigorous Clinical Laboratory Evaluation Program (CLEP). With this approval, the Laboratory is now positioned to deliver clinical-grade testing to patients and research participants across all 50 U.S. states.
Strengthening Clinical and Research Collaborations
Commenting on the achievement, Masoud Toloue, PhD, Chief Executive Officer of Quanterix, emphasized the company’s commitment to advancing partnerships that fuel therapeutic discovery and development:
“Collaboration is at the core of the Quanterix Accelerator Laboratory. 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 newly granted permit is more than just a regulatory checkbox. It opens the door for Quanterix to deepen collaboration with clinical researchers, pharmaceutical developers, and diagnostic innovators who rely on biomarker-driven insights to power their studies. By being certified to perform testing in New York—one of the largest and most highly regulated healthcare markets in the nation—Quanterix can now provide its partners with an unmatched combination of scientific precision, clinical reliability, and compliance rigor.
Inside the Quanterix Accelerator Laboratory
The Quanterix Accelerator Laboratory stands at the forefront of biomarker research and clinical assay development. At its core is the company’s Simoa® (Single Molecule Array) technology, which enables ultra-sensitive measurement of proteins and biomarkers at levels previously undetectable using traditional immunoassays.
This platform has been transformative in clinical research, allowing scientists to study disease processes with unprecedented clarity and monitor therapeutic responses with precision. Diseases of the central nervous system, immune system dysregulation, cancer, and infectious diseases have all been major areas of application for the technology.
Key highlights of the Lab’s capabilities include:
- Over 100 custom assay developments, tailored to the specific needs of pharmaceutical and academic research partners.
- Support for more than 264 global clinical trials, enabling biomarker insights that accelerate drug development pipelines.
- Dedicated project management teams to ensure efficient collaboration and timely results delivery.
- CLIA certification, which sets a high bar for laboratory quality and clinical testing standards.
With the addition of the New York State permit, the Lab strengthens its reputation as a trusted partner for translational medicine and precision diagnostics.
Meeting New York’s Rigorous Standards
The approval is particularly notable because New York State’s CLEP standards are among the toughest in the country. Unlike many states that defer to CLIA certification, New York conducts its own comprehensive evaluations of laboratory quality systems, personnel qualifications, analytical methods, and performance standards.
To secure this permit, the Quanterix Accelerator Laboratory had to demonstrate compliance with requirements that exceed baseline federal CLIA standards. These include extensive validation of test methods, documentation of quality assurance practices, and proficiency testing across multiple assay categories.
For biopharma partners, this ensures that any data generated by the Quanterix Accelerator Laboratory for New York-based trials meets the highest levels of regulatory scrutiny. For clinicians and patients, it provides additional confidence that the biomarker data used to inform diagnosis or treatment decisions is accurate and reliable.
Expanding Clinical Test Menu
As part of the permitting process, the Simoa® NfL (neurofilament light chain) Laboratory Developed Test (LDT) received authorization in New York. Neurofilament light chain is a key biomarker of neuroaxonal damage and has emerged as a critical tool in neurology research, particularly in conditions such as multiple sclerosis, Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), and traumatic brain injury.
The ability to quantify NfL with ultrasensitive accuracy allows clinicians and researchers to track neurodegeneration in real time, providing insights that could transform disease monitoring and therapeutic evaluation.
Quanterix has already announced plans to seek approval for additional clinical assays to broaden its test menu. These future expansions will likely include biomarkers relevant to oncology, immunology, and infectious diseases, reflecting the company’s strategic focus on delivering impactful clinical insights across multiple therapeutic areas.
Integration with Lucent Diagnostics
The Quanterix Accelerator Laboratory also operates under the Lucent Diagnostics brand, which provides advanced biomarker testing directly to clinicians and researchers. Through Lucent Diagnostics, healthcare providers can access serum and plasma biomarker assays powered by the Accelerator Lab’s Simoa® technology, translating cutting-edge science into actionable insights at the point of care.
This integration represents a key step in bridging the gap between translational research and clinical practice. By combining the rigor of a CLIA- and NYSDOH-certified laboratory with a diagnostic brand focused on patient impact, Quanterix is positioning itself as both a research partner and a clinical solutions provider.
A Track Record of Growth and Innovation
The New York State permit is the latest in a string of milestones that reflect Quanterix’s momentum:
- Scaling of custom assay services to meet the unique needs of pharmaceutical developers.
- Global trial support, with the company now playing a role in hundreds of clinical studies worldwide.
- Investments in laboratory infrastructure and compliance systems, ensuring operational excellence at scale.
- Commercial expansion of Lucent Diagnostics, bringing ultrasensitive biomarker testing closer to clinical decision-making.
This progress is underpinned by Quanterix’s overarching mission: to fuel scientific discovery and improve human health through better measurement of biology. By making the invisible measurable, the company is enabling breakthroughs in how diseases are diagnosed, monitored, and treated.
Implications for Biopharma and Healthcare
For biopharma companies, the Quanterix Accelerator Laboratory’s expanded certification means greater flexibility in selecting testing partners for clinical trials. It ensures that biomarker data generated in New York—the nation’s second-largest pharmaceutical market—meets both state and federal requirements.
For clinicians and researchers, it provides access to advanced testing methodologies that can yield more sensitive, specific, and reliable results than traditional assays. This could have significant implications for drug development timelines, patient stratification in clinical trials, and ultimately, the delivery of precision medicine.
For patients, particularly those affected by devastating neurological and immune-mediated conditions, it represents a step closer to earlier diagnoses, better monitoring of disease progression, and more targeted therapeutic interventions.
With the New York State permit secured, Quanterix is poised to extend its leadership in biomarker discovery and clinical testing. The company has signaled its intent to continue expanding its menu of validated assays, invest in next-generation Simoa® technologies, and deepen collaborations across academia, pharma, and clinical practice.
In an era where biomarkers are increasingly central to precision medicine and regulatory approvals, the ability to deliver clinically validated, ultrasensitive assays is not just a technical achievement—it is a strategic differentiator.
The New York State Department of Health’s approval of the Quanterix Accelerator Laboratory in the Clinical Chemistry category represents a pivotal milestone for the company and the broader field of biomarker science. By securing one of the most rigorous state-level certifications in the country, Quanterix has reaffirmed its commitment to quality, compliance, and scientific innovation.
Through the Accelerator Laboratory and its integration with Lucent Diagnostics, the company is bridging the gap between research and clinical practice, enabling actionable insights that can transform drug development and patient care.
As the healthcare ecosystem increasingly relies on biomarkers to guide therapeutic decisions, Quanterix is well-positioned to remain a driving force in the future of precision medicine.
