Biomarker analysis firm Quanterix has secured breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its Simoa neurofilament light chain (NfL) test for multiple sclerosis (MS).
Simoa measures NfL in human serum and plasma and is intended to help identify patients with relapsing-remitting MS who are at risk of relapse within four years. The designation comes after a study published March 1 in The Lancet Neurology described the effective use of Simoa to interpret elevated NfL values in MS patients, the company said.
