Quanterix Corporation announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Simoa® neurofilament light chain (NfL) plasma test for patients with relapsing-remitting multiple sclerosis (MS), as published in the company’s press release.

The NfL device is a digital immunoassay that measures NfL in serum and assesses the risk of relapse in these patients.

“For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options,” said Kevin Hrusovsky, chairman and chief executive officer of Quanterix and founder of Powering Precision Health.

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“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.”

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The device is expected to aid clinicians in tailoring the treatment approach for patients with relapsing-remitting MS by determining, along with clinical, imaging, and laboratory data, the risk of relapse within 4 years. The Breakthrough Device Designation follows a recent study published in The Lancet Neurology, which demonstrated the ability of Quanterix’ technology to accurately identify increased serum NfL levels in patients with MS.

In addition, at least 20 studies cited at the American Academy of Neurology 74th Annual Meeting referenced the assay, further confirming the potential usefulness of this biomarker.

While the Breakthrough Device Designation does not guarantee approval by the FDA, the growing body of research supporting NfL as a useful biomarker is an exciting advance in MS research with the potential to significantly improve clinicians’ ability to assess patients’ prognosis and monitor their treatment responses.


Quanterix granted Breakthrough Device Designation from U.S. FDA for NfL test for multiple sclerosis. News release. Quanterix Corporation; April 22, 2022.