Quanterix Receives FDA Breakthrough Device Tag For NfL Test For Multiple Sclerosis

Quanterix Corp QTRX received FDA breakthrough device designation for multiple sclerosis (MS) diagnostic.
Quanterix designed its Simoa neurofilament light chain (NfL) plasma test as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting MS (RRMS).
According to a news release, the company designed the digital immunoassay to quantitatively measure NfL in human serum and plasma.
It has shown promise in conjunction with clinical, imaging, and laboratory findings to identify RRMS patients at lower or higher risk for relapse within four years, offering assistance in tailoring the therapeutic approach to treat the disease more effectively.
The breakthrough nod follows a large-scale, international study published in The Lancet Neurology.
The study demonstrated that the Simoa technology helped establish a new method for clinicians to identify and interpret elevated values of sNfL in individual MS patients.
Last October, the company received FDA Breakthrough Device status for Simoa phospho-Tau 181 (pTau-181) blood test to aid in the diagnostic evaluation of Alzheimer's Disease.
Price Action: QTRX shares are down 0.37% at $24.43 during the market session on the last check Friday.