Roche’s Elecsys NfL test offers a minimally invasive testing option that can provide rapid answers to patients and caregivers to aid in the detection of disease activity in adults with Multiple Sclerosis, supporting better disease management decisions
Roche Diagnostics in Rotkreuz, Switzerland. (Credit: F. Hoffmann-La Roche Ltd)
Roche has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its Elecsys NfL (neurofilament light chain) test for Multiple Sclerosis (MS).
Elecsys NfL is intended to help detect disease activity in adults aged 18 to 55 years, with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS).
NfL is a type of protein exclusively found in neurons and is a sensitive indicator of neuroaxonal damage.
Under normal conditions, NfL is released from axons at a low level. However, its rate of release increases with age and following neuroaxonal damage.
The abnormal, elevated levels of NfL detected in cerebrospinal fluid and blood can be related to various acute and chronic neurological disorders.
The disorders include traumatic brain injury, amyotrophic lateral sclerosis, frontotemporal dementia, Alzheimer’s disease, Huntington’s disease and other neurodegenerative diseases.
Roche Diagnostics CEO Matt Sause said: “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.
“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.”
The Swiss healthcare company said that around 85% of MS cases constitute RRMS patients.
Also, most of the people diagnosed with RRMS eventually transition to SPMS, which results in worsening of neurologic function and increased disability over time.
The detection of disease activity is important for patients with RRMS and SPMS, for making the best possible decisions for the management of the disease.
Roche said that its Elecsys NfL has the potential to help laboratories scale MS testing on its fully automated cobas instruments with IVD quality.
Last year, the FDA granted Breakthrough Device Designation to Roche’s Elecsys Amyloid Plasma Panel, a new solution that enables earlier detection of Alzheimer’s disease.