Roche’s MS test scores FDA breakthrough device designation

10 November 2023

Roche’s Elecsys neurofilament light chain (NfL) test is used for detecting disease activity in multiple sclerosis.

Roche has received a breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys neurofilament light chain (NfL) test.

Multiple sclerosis is a high-grossing indication for Roche. Image Credit: JHVEPhoto / Shutterstock.

The Elecsys NfL test is intended for detecting disease activity in adults, aged 18-55 years, with relapsing-remitting or secondary progressive multiple sclerosis.

Multiple sclerosis is a high-grossing indication for Roche. The company’s Ocrevus (ocrelizumab) is a top-selling drug in the indication and is expected to generate $6.3bn in global sales in 2030, as per GlobalData.

“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 optimisation,” said Roche Diagnostics CEO Matt Sause.

“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.”

Elecsys NfL test measures NfL protein, which is present in neurons and is an indicator of neuroaxonal damage. Abnormally elevated levels of NfL in cerebrospinal fluid can be used to detect neurological damage.

Roche is also investigating the use of NfL tests in other acute and chronic neurological disorders, including traumatic brain injury and Alzheimer’s disease.

Roche Elecsys portfolio also includes interleukin 6 (IL-6) immunoassay for diagnosing neonatal sepsis, and beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays for diagnosing Alzheimer’s disease.

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