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 to identify 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 a large-scale, international study published in The Lancet Neurology. The study demonstrated that the ultra-sensitive Simoa technology helped establish a new method for clinicians to identify and interpret elevated values of sNfL in individual MS patients.
“For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options,” Quanterix Chair and CEO Kevin Hrusovsky said in the release. “Obtaining FDA breakthrough device designation for our plasma NfL MS test was a key objective for 2022. We are pleased to have the opportunity to work with the FDA to help advance the Quanterix Simoa NfL test towards regulatory approval.”