Quanterix’s Multiple Sclerosis Test Designated a Breakthrough Device by the FDA

Digital biomarker analysis company Quanterix has been granted the FDA’s Breakthrough Device designation for its Simoa neurofilament light-chain (NfL) plasma test for multiple sclerosis (MS).

The immunoassay, which assesses the risk of disease activity in patients with the relapsing-remitting form of MS, may be used in conjunction with clinical, imaging and laboratory findings to help identify patients who are at lower or higher risk for relapse within four years.

The plasma test results could help tailor the therapeutic approach to more effectively treat the disease, the Billerica, Mass.-based company said.