Quantitative test to measure neurofilament light chain validated

Quanterix Corp. announced the validation of a laboratory developed test to quantitatively measure neurofilament light chain in serum as an aid in the evaluation of those who may have neurodegenerative conditions.

Neurofilament light chain (NfL) is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological conditions, according to a press release from Quanterix.

Any disorder or injury that results in neuronal damage can result in the release of NfL into the interstitial fluid and cerebrospinal fluid. Some of these proteins diffuse into the blood, where concentrations are typically 50- to 100-fold lower than in the CSF and difficult to measure.

According to the release, the FDA in 2022 granted breakthrough device designation for Quanterix’s Simoa NfL test as a prognostic aid in assessing the risk for disease activity in patients diagnosed with relapsing-remitting MS.

“Assessment and monitoring of brain health is incredibly difficult and typically performed in limited fashion by surgery or imaging,” Quanterix CEO Masoud Toloue said in the release. “We see NfL as not only an important marker for neurodegenerative disease but also a critical measure of brain-related side effects during chemotherapy, CAR T-cell therapy and stroke.”

Quanterix’s Simoa NfL test will be offered through the company’s accelerator laboratory, a licensed and accredited laboratory fully equipped to support clinical diagnostic testing and translational research.