Fujirebio Launches 2 Automated Tests to Quantify Key Protein in Blood and CSF

 

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

When nerve cells are damaged, NfL, a structural protein found in them, is released into the cerebrospinal fluid (CSF), the fluid surrounding the brain and spinal cord, and into the bloodstream.

NfL levels in the blood and CSF are increasingly being used to assess the extent of nerve cell damage in people with neurodegenerative diseases. In MS, this protein is thought to be a promising biomarker for monitoring disease activity and progression, as well as prognosis and treatment responses.

According to Fujirebio, the new Lumipulse G NfL CSF and Lumipulse G NfL Blood tests are designed to provide NfL levels in just 35 minutes. For the time being, the tests are only available for research purposes.

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

“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 are immunoassays that use a specific antibody to detect a protein of interest. They are performed on the company’s fully automated Lumipulse G instruments.

The antibodies are labeled with an enzyme that produces light in proportion to the amount of protein in the sample. These tests are extremely sensitive, detecting even trace amounts of NfL.

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

Researchers may continue to investigate the clinical utility of NfL in a variety of neurodegenerative conditions, including amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, and acute neurological diseases, using these biomarker tests (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 test for a variety of other disease biomarkers, such as interleukin-6, an inflammatory marker, vitamin D, and beta-amyoloid, an Alzheimer’s marker. Some of these tests, like NfL, are only available for research purposes, but others can be used for routine clinic monitoring of patients.

Fujirebio believes the system meets the sample output, quality, and regulatory requirements needed to support the future routine use of NfL.

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