A new dawn breaks for blood tests in neurological diseases, though future data remain important.
Evaluate Vantage | June 2, 2023
Qalsody, Biogen’s therapy for a specific form of amyotrophic lateral sclerosis, in April became the first neurological drug whose accelerated approval was based on a levels of a surrogate biomarker in patients’ blood. This is great news for Quanterix, maker of the leading blood test for the biomarker in question, neurofilament light chain.
“Blood is a great proxy for whether the drug is working the way you’d like it to work,” says Masoud Toloue, chief executive of Quanterix. The group hopes that Qalsody’s approval will presage the use of more blood biomarkers for approval decisions and other applications. But some clinical data have been questionable, and much will depend on Qalsody’s confirmatory trial.