Labcorp is moving into a different segment of testing with the launch of its latest diagnostic. The Burlington, NC-based company said it has developed a test that can give greater insight into neurodegeneration and neuronal injuries such as Multiple Sclerosis, Alzheimer’s, Parkinson’s, and Concussions.
The Neurofilament Light Chain (NfL) blood test will allow doctors to identify and verify signs of neurodegenerative disease, enabling physicians to provide a more effective and efficient path to diagnosis and treatment for patients. Elevated NfL levels signal neuronal injury, whether from diseases like multiple sclerosis, Alzheimer’s, and Parkinson’s, or brain injury, such as concussion.
The NfL test brings Labcorp to the forefront of the recent changes that are occurring in neurology, said Joseph Volpe, neurology business segment and discipline director at Labcorp.
“The field of neurology is changing so rapidly now,” Volpe told MD+DI. “[Neurology] is moving toward a more blood-based diagnostics business, that is going to include a lot more blood biomarkers – particularly in fields like Alzheimer’s and Parkinson’s. The [NfL] test really sets the stage and is the groundwork for being able to bring into the market a lot more of those biomarkers in the future.”
NfL isn’t a newly discovered biomarker, and it has been widely studied in research settings. However, this is one of the first times a company has developed a commercial test around the biomarker, Volpe said. He pointed out that there were a few reasons why Labcorp was one of the first companies to move forward with a test using the NfL biomarker.
“Just because something is being well-studied in the literature and doctors are very familiar with it, doesn’t necessarily translate into a clear path for commercialization,” Volpe said. “So, a lot of times what must happen is a lot of nuanced negotiation with a lot of suppliers who produce these types of reagents in order to make sure deals can be made such that everyone is happy to get a product out of the door.”
He added, “in this case, Labcorp worked really hard with some good partners that we have to make sure that we were going to be able to offer this product.”
The concept of blood-based tests in neurology is catching on.
Abbott Laboratories won a nod from FDA for a hand-held blood plasma test in January of 2021.
The Abbott Park, IL-based company’s test enables a quick and quantified analysis of suspected concussions without waiting for imaging to be done and read. Abbott developed the test in collaboration with the U.S. Department of Defense; the partnership, was announced in 2014.
A little more than two years ago, Billerica, MA-based Quanterix announced progress on the Single Molecule Array technology to generate data on the value of blood biomarkers as research tools to study pathophysiological mechanisms of concussion and as potential clinical tools and objective indicators for sports-related concussions and mild TBIs.
Labcorp Working Overtime
Labcorp has had its hands full recently. The company announced it was offering monkeypox testing. About a week ago, the Labcorp said it would use the Centers for Disease Control and Prevention’s orthopoxvirus test, which detects all non-smallpox related orthopoxviruses, including monkeypox.
And in May, LabCorp turned its attention to skin cancer with a new test that determines the level of expression of the lymphocyte-activation gene 3 (LAG-3).