Fujirebio launched 2 automated tests to quantify key protein in blood, CSF

Fujirebio has launched two fully automated laboratory tests to measure levels of the neurofilament light chain (NfL) protein, a proposed biomarker of nerve cell damage in multiple sclerosis (MS), in the blood and spinal fluid.

NfL is a structural protein found in nerve cells that gets released into the cerebrospinal fluid (CSF) — the fluid surrounding the brain and spinal cord — and into the bloodstream when these cells are damaged.

Elevations in NfL levels in the blood and CSF are increasingly used as an indicator of the extent of nerve cell damage in people with neurodegenerative diseases. In MS, this protein is considered a promising biomarker to help monitor disease activity and progression, as well as prognosis and responses to treatment.

According to Fujirebio, the novel tests — called Lumipulse G NfL CSF and Lumipulse G NfL Blood — are designed to provide measurements of NfL levels in just 35 minutes. For now, the tests are available for research use only.

Fujirebio last year debuted three fully automated blood-based lab tests of other biomarkers.

“We are now proud to once again expand our neurodegenerative disease portfolio with the highly anticipated NfL biomarker,” Christiaan De Wilde, CEO at Fujirebio Europe and global head of neuro business, said in a company press release.

The Lumipulse G NfL tests, which run on the company’s fully automated Lumipulse G instruments, are immunoassays, in which a specific antibody is used to detect a protein of interest.

The antibodies are labeled with an enzyme that generates light according to the amount of the protein present in the sample. These tests are very sensitive and can detect even small amounts of NfL.

We are working diligently to create a solid lineup of tests for the entire neurodegenerative disease field as quickly as possible.

Using these biomarker tests, researchers may continue to study the clinical utility of NfL in several neurodegenerative conditions, including amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, and acute neurological diseases (e.g. traumatic brain injury).

“The assay menu offered by other industry leaders today is still limited and we are working diligently to create a solid lineup of tests for the entire neurodegenerative disease field as quickly as possible,” De Wilde said.

In addition to NfL, the Lumipulse G system can run tests for multiple other disease biomarkers, including interleukin-6, a marker of inflammation, vitamin D, and beta-amyoloid, a marker of Alzheimer’s. Like NfL, some of these tests are available for research only, but others can be used for routine monitoring of patients in the clinic.

Fujirebio believes the system follows the necessary levels of sample output, quality, and regulatory requirements to support the future routine use of NfL.