<!–
–>
Roche has received a breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys neurofilament light chain (NfL) test.
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.
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
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.
<!– –>
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://www.medicaldevice-network.com/news/roches-ms-test-scores-fda-breakthrough-device-designation/
