22 April 2022 - - US-based digitizing biomarker analysis specialist Quanterix Corp's (NASDAQ: QTRX) Simoa neurofilament light chain plasma test has been granted Breakthrough Device designation by the US Food and Drug Administration as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting MS, the company said.

The FDA's Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis or treatment of life-threatening diseases with an unmet medical need.

The program is designed to enable accelerated development, assessment and review processes, with the intention to provide patients with more timely access to breakthrough technologies or devices.

However, Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.

The Quanterix Simoa NfL test is a digital immunoassay that quantitatively measures NfL in human serum and plasma and shows promise to be used in conjunction with clinical, imaging and laboratory findings as an aid in identifying RRMS patients who are at lower or higher risk for relapse within four years.

This prognostic information could be useful in tailoring the therapeutic approach to more effectively treat the disease.

The designation comes on the heels of a large-scale, international study published in The Lancet Neurology, in which researchers from the University Hospital Basel and University of Basel leveraged Quanterix' ultra-sensitive Simoa technology to help establish a new method for clinicians to identify and interpret elevated values of sNfL in individual MS patients.

Along with this research, the Simoa NfL assay was referenced in at least 20 studies presented at the American Academy of Neurology (AAN) 74th annual meeting, further validating the biomarker's potential utility.

Quanterix is a company that's digitizing biomarker analysis with the goal of advancing the science of precision health.

The company's digital health solution, Simoa, has the potential to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.

Quanterix' technology is designed to enable 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 research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts.