Quanterix Granted Breakthrough Device Designation from U.S. FDA for NfL Test for Multiple Sclerosis

Quanterix Granted Breakthrough Device Designation from U.S. FDA for NfL Test for Multiple Sclerosis

Apr 22, 2022 by Business Wire Health: Oncology News

Key Facts

  • “For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options” > > Tweet this 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.

  • 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.
  • “There has been an ever-growing body of research with the Simoa® NfL blood test supporting NfL as a reliable biomarker for MS disease activity prognosis and treatment response monitoring,” said Dr. Mark S. Freedman, Professor of Neurology and Director of Multiple Sclerosis Research at the Ottawa Hospital.
  • “The FDA’s grant of Breakthrough Device designation for this test has the potential to help the multiple sclerosis community further advance the optimal use of NfL measurements in both research and clinical practice aimed at more effective therapeutic management of the disease for the millions of patients suffering from the condition.”

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