Quanterix Corporation announced the validation of a Laboratory Developed Test (LDT) to quantitatively measure neurofilament light chain (NfL) in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage. NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders. Any disorder or injuring force resulting in neuronal damage can lead to the release of NfL into the interstitial fluid and cerebrospinal fluid (CSF). A fraction of these proteins diffuses into the blood, where concentrations are typically 50- to 100-fold lower than in CSF and difficult to measure with conventional immunoassay technologies. Measurement of this protein in serum and plasma was first enabled with the release of the research use only (RUO) Simoa NfL kit several years ago. Simoa NfL is the most widely published NfL test with hundreds of research papers demonstrating its validity for assessing neuronal damage, and it has become widely adopted in therapeutic clinical trial designs. Published research using the Simoa NfL test has shown correlations between increased serum NfL levels and neuronal injury across a range of disorders, including amyotrophic lateral sclerosis (ALS), Huntington's disease, HIV infection, Parkinsonian disorders, traumatic brain injury (TBI), concussion, small vessel disease, Alzheimer's disease, and multiple sclerosis (MS). Additionally, recent studies characterizing changes of blood NfL levels in normal aging populations have provided
necessary reference range values to aid the interpretation of measurements from individuals being evaluated in clinical care settings. Simoa NfL measurements have supported approval of therapeutics, such as Novartis' Kesimpta (ofatumumab) for MS, and have been used in a number of therapeutic trials related to Alzheimer's disease, including Eisai's lecanemab Phase 3 Clarity AD study, highlighted at the recent Clinical Trials for Alzheimer's Disease (CTAD) conference. Last year, the FDA granted Breakthrough Device designation for Quanterix's NfL test as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting MS (RRMS). The FDA's Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis or treatment of life- threatening diseases with an unmet medical need. The program is designed to enable accelerated development, assessment, and review processes, with the intention to provide patients with more timely access to breakthrough technologies or devices.