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LEXINGTON, Mass.鈥擬ay 17, 2017鈥� , a company digitizing biomarker analysis to advance the science of precision health, today announced the launch of the Simoa鈩� Neurology 4-Plex A assay (N4PA). The Simoa N4PA assay is the first test that can simultaneously measure four protein biomarkers from either cerebrospinal fluid (CSF) or directly from blood samples for the study of traumatic brain injury (TBI) and other neurodegenerative conditions. The four biomarkers used on the panel include neurofilament light (NF-L), tau, glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1). Launch of the Simoa N4PA panel will be highlighted this week in Boston at Brain Trust: Pathways to InnoVAtion, the 2nd annual event hosted by the Department of Veteran Affairs (VA).

Recent studies indicate that serum NF-L is a biomarker for mild TBI in amateur boxers and professional hockey players1, that plasma tau is related to concussion severity and return-to-play2, and that serum GFAP and UCH-L1 can detect mild to moderate TBI.3 The has also hosted a 2017 Consensus Conference, where thought leaders have identified NF-L, tau, GFAP and UCH-L1 as the top four fluid biomarkers of interest for mild TBI assessment.

鈥淭he Simoa N4PA panel is an essential research tool for assessing head trauma-induced neural damage, particularly mild cases of TBI, which are the hardest to detect,鈥� said Kevin Hrusovsky, Executive Chairman and Chief Executive Officer at Quanterix. 鈥淭he assay is the first of its kind to detect all four key neuro biomarkers linked to TBI. This can be done simultaneously in a single well, at 1/1000th of the concentration level required by traditional ELISAs. As a result of continued product advances, we plan to usher this ultrasensitive multiplex technology into the clinic, and develop the most accurate and predictive tests for neurological disorders. So many people in this world suffer from head trauma and its deleterious effects. Our digital biomarker tests could revolutionize objective testing and lead to a new standard of care for treating concussions and neurodegenerative disease.鈥�

The assay鈥檚 high degree of sensitivity allows the use of blood serum or blood plasma to detect neurological biomarkers, in place of conventional CSF sampling that is invasive and painful. Similarly, ultra-low level detection enables measuring biomarkers, from early/mild stages to severe impairment.

鈥淭he design of this multiplexed assay will provide researchers with the insights needed to speed the development of a new generation of diagnostic products that will hopefully be useful for early detection of neurological disease,鈥� said Henrik Zetterberg, M.D., Ph.D., Professor of Neurochemistry and Head of the Department of Psychiatry and Neurochemistry, Sahlgrenska Academy, University of Gothenburg. 鈥淐omparing the diagnostic and prognostic utility of tau, NF-L, UCHL-1 and GFAP head-to-head in samples collected at different time points following traumatic brain injury will give us new information on how we could potentially use these markers in clinical practice.鈥�

The Simoa N4PA assay is for research use only and not for use in diagnostic procedures. The assay kit includes Simoa reagents, calibrators, multiplex Simoa beads, detector antibodies, and sample diluent required to run up to 96 tests. It is available for immediate purchase to run on the Simoa HD-1 Analyzer or via the Simoa Accelerator Lab, an innovation center for biomarker research, custom assay development and clinical sample testing.

Research and development of neurological tests including the Simoa N4PA assay is a result of two GE and NFL Head Health Challenge grants that have been awarded to Quanterix since 2015.

About Quanterix

is a company that鈥檚 digitizing biomarker analysis to advance the science of precision health. The company鈥檚 digital health solution, Simoa, is changing the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. In doing so, Quanterix enables much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for applications in a majority of therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Lexington, Massachusetts.

Legal Notice:

Simoa鈩� is a registered trademark of Quanterix, Inc.

References

1. Shahim P, Zetterberg H, Tegner Y, Blennow K. . Neurology 2017; (e-version ahead of print).

2. Gill J, Merchant-Borna K, Jeromin A, Livingston W, Bazarian J. . Neurology. 2017: 7;88(6):595-602.

3. Papa L, Brophy GM, Welch RD, Lewis LM, Braga CF, Ciara NT, et al. . JAMA Neurol 2016; 73(5):551-60.