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