Quanterix Poised to Launch Test That Monitors NfL Levels
Simoa NfL LDT blood test is for neurodegenerative diseases, including MS
Quanterix Corporation‘s laboratory test designed to measure blood levels of neurofilament light chain (NfL) has been validated by the Clinical Laboratory Improvement Amendments (CLIA), an arm of the U.S. Food and Drug Administration (FDA) that regulates laboratory testing.
The company now is planning to launch its laboratory developed test, called Simoa NfL LDT, to help monitor neuronal damage in people with neurodegenerative diseases, including multiple sclerosis (MS).
The test will be available through Quanterix’s Accelerator Laboratory, which is dedicated to biomarker research and clinical sample testing. This laboratory is CLIA-licensed, which ensures quality laboratory testing, and ISO 15189 accredited, meaning it is a competent, impartial, and accurate functioning medical laboratory.
“Today is another translational step on our mission. We expect the launch of our CLIA validated NfL blood test to power future therapeutic trials and advance clinical care,” Masoud Toloue, CEO at Quanterix, said in a company press release.
NfL is a protein found on nerve fibers that is released into the spinal fluid and bloodstream when nerve cell damage occurs. In MS, levels of this protein are elevated in the blood, and may help predict disease progression and response to treatment in patients.
While this means that NfL levels in circulation could serve as a biomarker of disease progression in people with neurodegenerative conditions, the amount of NfL that actually reaches the blood is difficult to measure using conventional technologies.
The Simoa NfL test, initially developed for research purposes, was the first to accurately measure NfL levels in the blood. The test was designed detect single molecules of NfL via an ultra-sensitive immunoassay, which enabled researchers to detect NfL levels with up to 1,000 times greater sensitivity than conventional measurements.
Using this test, it was possible to establish a correlation between increased serum NfL levels and neuronal injury in several disorders, including MS, amyotrophic lateral sclerosis, Huntington’s disease, and Alzheimer’s disease.
The test has been used in several clinical trials to monitor neurofilament light chain levels, and supported the approvals of a number of therapies, including the CD20 antibody Kesimpta (ofatumumab).
“Assessment and monitoring of brain health is incredibly difficult and typically performed in limited fashion by surgery or imaging. 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,” Toloue said.
Last year, the Simoa NfL test received breakthrough device designation from the FDA as a prognostic parameter to assess the risk of disease activity in people with relapsing-remitting MS.
This designation is granted to products that may improve the diagnosis or treatment of life-threatening diseases and is designed to accelerate the platform’s development toward regulatory approval.
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