Quanterix (Nasdaq:QTRX) announced today that it received FDA breakthrough device designation for a multiple sclerosis (MS) diagnostic.
Billerica, Massachusetts-based 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 as an aid in identifying RRMS patients who are at lower or higher risk for relapse within four years, offering assistance in tailoring the therapeutic approach to more effectively treat the disease.
The breakthrough nod follows the publishing of a large-scale, international study in The Lancet Neurology. The study demonstrated that the ultra-sensitive Simoa technology helped establish a new m…