FDA grants breakthrough device designation for MS plasma test

The FDA has granted breakthrough device designation to Quanterix Corp. for its Simoa neurofilament light chain plasma test, a prognostic aid that assesses risk for disease activity in patients with relapsing-remitting MS.

“For the more than 2 million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options,” Quanterix CEO and Chairman Kevin Hrusovsky, said in a company press release.

Breakthrough device designations are typically granted to products that have the potential to offer more effective diagnosis or treatment for life-threatening diseases with an unmet medical need. Although the breakthrough device designation was granted, it does not guarantee the application will be approved.

The Simoa neurofilament light chain plasma test is a digital immunoassay that measures neurofilament light in human serum and plasma and could be used in conjunction with clinical, imaging and laboratory findings to help identify relapsing-remitting MS patients who are at risk for relapse within 4 years.

“Obtaining FDA breakthrough device designation for our plasma [neurofilament light] MS test was a key objective for 2022,” Hrusovsky said. “We are pleased to have the opportunity to work with the FDA to help advance the Quanterix Simoa [neurofilament light] test towards regulatory approval.”