Blood Test for MS Activity Gets FDA Breakthrough Designation

The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Elecsys Neurofilament Light Chain (NfL) test for multiple sclerosis (MS).

Made by Roche, the test is intended to be used as an aid in detection of disease activity in adults aged 18-55 years with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), providing insights for disease management.

Rising NfL levels are a known indicator of neuroaxonal injury and correlate with MS disease activity. Levels rise in the presence of an MS relapse or MRI activity and fall following treatment with disease-modifying therapies.

As reported earlier by Medscape Medical News, an analysis of NfL in two large MS cohorts found that elevated levels of the neuronal protein at baseline were associated with large increases in future disability risk, even in patients with no clinical relapse.

“For patients with RRMS and SPMS, detection of disease activity is critically important in enabling them and their physicians to make the best possible decisions for the management of the disease,” Roche said in a news release announcing the FDA breakthrough designation for the Elecsys NfL test.

The test has the potential to “improve outcomes for MS patients by offering a minimally invasive blood draw that can deliver rapid results,” said Matt Sause, CEO of Roche Diagnostics.

The Elecsys NfL test could “help laboratories to scale MS testing on widely available, fully automated, and standardized Roche cobas instruments with the confidence of in-vitro diagnostics quality in a timely manner,” the company added.

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