The Quanterix Corporation’s https://www.quanterix.com goal to advance the science of precision health. The company’s digital health solution, Simoa® has the potential to change healthcare by giving researchers the ability to closely examine the continuum from health to disease.
Recently, Quanterix announced that their Simoa® Neurofilament Light Chain (NfL) plasma test has been granted Breakthrough Device designation by FDA https://www.fda.gov as a prognostic aid in assessing the risk of disease activity in patients with Relapsing Remitting MS (RRMS).
“For more than two million people suffering from MS worldwide, there is an important need for more informed and effective treatment options. Obtaining FDA breakthrough device for our plasma NfL MD test was our key objective for 2022 and we are pleased to work with FDA to advance the test towards regulatory approval.” said Kevin Hrusovsky, Chairman and CEO, Quanterix and Founder of Powering Precision Health.
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.
Previously, according to Dr. Tanuja Chitnis, Professor of Neurology at Brigham and Women’s Hospital, Harvard Medical School, “This new test incorporates results available from the Army’s Medical Research and Development Command via the Congressionally Directed Medical Research Program’s (CDMRP) https://cdmrp.army.mil Multiple Sclerosis Research Program (MSRP).
According to Dr. Chitnis, the new test has several advantages for patients and doctors, such as convenience as the test can be done in an office setting and does not require the use of an MRI. The test can lead to closer monitoring of the risk, relapse, and or better treatment outcomes, and ultimately prevent longer term disability.