Quanterix has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Simoa neurofilament light chain (NfL) plasma test for multiple sclerosis (MS).
The blood-based assay has obtained the designation as a prognostic aid for evaluating the disease activity risk in relapsing-remitting MS (RRMS) patients.
The digital immunoassay Simoa has been designed to quantitatively measure NfL in human serum and plasma.
Additionally, it can be used in conjunction with clinical, imaging and laboratory findings to identify RRMS patients at either lower or increased risk of relapse within four years.
Based on this information, the therapeutic approach for most effectively treating the disease can be determined.
Quanterix chairman and CEO Kevin Hrusovsky said: “For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options.
“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.”
The FDA’s designation follows a global study in which researchers at the University Hospital Basel and University of Basel, Switzerland, established a new approach to enable clinicians to identify and interpret high sNfL values in individual MS patients using the Simoa technology from Quanterix.
Quanterix noted that this is the company’s second test to receive Breakthrough Device status.
Last year, the company’s phospho-Tau 181 (pTau-181) assay for Alzheimer’s disease also received the designation.
In December 2020, the FDA issued an Emergency Use Authorization for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test.