Quanterix has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Simoa neurofilament light chain (NfL) plasma test for multiple sclerosis (MS).
The blood-based assay has obtained the designation as a prognostic aid for evaluating the disease activity risk in relapsing-remitting MS (RRMS) patients.
The digital immunoassay Simoa has been designed to quantitatively measure NfL in human serum and plasma.
