FDA names Elecsys NfL blood test for MS a breakthrough device

A test called Elecsys NfL  — developed by Roche to measure blood levels of the nerve damage biomarker neurofilament light chain (NfL) in people with multiple sclerosis (MS) — has received breakthrough device designation in the U.S.

That status, granted by the U.S. Food and Drug Administration (FDA), is meant to advance products that more effectively diagnose or treat life-threatening diseases. It offers a range of incentives, including more frequent interactions with FDA experts and priority review.

The Elecsys NfL test is believed to help detect disease activity in adults, ages 18-55, with relapsing types of MS.

In so doing, it may provide key insights to rapidly adjust disease management approaches in patients with relapsing-remitting MS (RRMS) — the condition’s most common form — or secondary progressive MS (SPMS), the stage that typically follows RRMS.

“We are excited about the potential Elecsys NfL has to improve outcomes for MS patients by offering a minimally invasive blood draw that can deliver rapid results,” Matt Sause, Roche Diagnostics’s  CEO, said in a company press release.

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Elecsys may help in disease management in RRMS, SPMS

MS is caused by the immune system erroneously attacking the myelin sheath, the fatty coating around nerve fibers that helps them communicate more efficiently. The resulting myelin loss, called demyelination, leads to impaired nerve function and a range of symptoms.

RRMS is the most common form of MS, accounting for around 85% of newly diagnosed MS cases. It is characterized by relapses, or periods where new symptoms suddenly appear or old symptoms worsen, followed by remissions, which are periods of partial or complete symptom recovery.

Without treatment, most people with RRMS will transition to SPMS within two or three decades after disease onset. In this phase, disease symptoms steadily worsen over time, even if the patient has no relapses.

Detection of disease activity and confirmed disability progression is critical for improving the management of people with RRMS and SPMS. For example, patients with more active disease will generally need highly effective disease-modifying treatments (DMTs) to keep their symptoms under control and prevent more disability from accruing.

In recent decades, doctors have used MRIs to monitor disease activity in these patients, or have looked at patient records to determine their relapse rates. However, follow-up MRIs are generally recommended every six months to two years, and relapse rates require that patients are followed for long periods of time, which is not feasible for assessing if a treatment is working as it should.

After diagnosis, many face challenges with managing their disease due to significant gaps in access to testing. This can lead to missed opportunities to detect disease progression in support of treatment optimization.

Given these issues, better tools are needed to improve disease management, Sause said, noting that “around 2.8 million people are estimated to live with multiple sclerosis.”

“After diagnosis, many face challenges with managing their disease due to significant gaps in access to testing. This can lead to missed opportunities to detect disease progression in support of treatment optimization,” Sause said.

NfL is an established biomarker of nerve damage. The protein helps to provide structure to nerve fibers, but is released to the surrounding fluids when nerve cells are damaged. Eventually, high levels of NfL will become detectable in the blood and spinal fluid.

Increased levels of NfL have been extensibly reported in people with MS and other neurological disorders, such as Alzheimer’s disease and Huntington’s disease. In MS, the biomarker is believed to help detect disease activity.

“With Elecsys NfL receiving this designation, it is an important step as the organization strengthens its diagnostics neurology portfolio to meet growing societal needs,” the company stated in the press release.

If approved, Roche’s Elecsys NfL test likely will be integrated into the fully automated and standardized Roche instruments, enabling the test to become widely available to MS patients in a timely manner, according to the company.