The clinical services giant Labcorp is rolling out its first blood test to help identify and confirm the signs of multiple neurodegenerative diseases and brain injury, including ALS, dementia and Parkinson’s disease, as well as concussions.
The diagnostic tracks a particular kind of protein—known as neurofilament light chain, or NfL—as found in the bloodstream. Originally produced inside the brain’s neurons, it can be released into the body in higher-than-normal amounts when those cells come under strain.
“Importantly, NfL isn’t specific to one disease, but it is highly specific to neuronal damage from a wide variety of causes, from Alzheimer’s and multiple sclerosis to concussion and physical injury,” Labcorp’s neurology business segment director, Joseph Volpe, said in a statement.
“Serial use of NfL testing can help doctors to follow trends that indicate the effectiveness of medicines or therapies, or whether there is continued injury or disease progression,” Volpe added.
The test can be performed from a standard blood draw done at a hospital, doctor’s office or one of Labcorp’s patient service centers. The goal is to offer neurologists with a simpler, more objective tool that provides direct evidence of trauma within the brain, allowing for a faster diagnosis.
In Alzheimer’s, for example—which Labcorp estimates affects more than 6 million people in the U.S.—the NfL test can assess patients that have begun to show the more subjective signs of declining memory and can help predict the disease’s progression. Labcorp also offers tests to analyze samples of cerebrospinal fluid and other proteins associated with an increased risk of onset.
NfL can also be used alongside other clinical evaluation methods to determine whether an athlete can return to play following a concussion.
Last year, researchers at King’s College London found that though different and increasing amounts of NfL proteins are expected to be seen as a person ages, abnormally high blood levels could provide earlier warnings before clinical signs of neurodegeneration become definitive.
Using a supersensitive test, they found small differences in readings could indicate rarer courses of Parkinson’s disease, as well as help identify patients with Down syndrome that may or may not also have dementia or a predisposition to Alzheimer’s disease.
And this past April, the FDA granted a breakthrough designation to the blood test developer Quanterix for its NfL diagnostic designed to gauge the risk of relapse among people with multiple sclerosis.
Though relapsing-remitting MS can be managed with approved treatments, there is currently no FDA-cleared method to predict when or if another relapse will occur—including periods of new or worsening symptoms, such as double vision, numbness, weakness and balance issues.
Quanterix’s immunoassay is designed to be used alongside other clinical, imaging and lab tests to determine the risk that a patient will relapse within the next four years.