The FDA has granted the plasma NFL assay Breakthrough Device designation as a prognostic aid in assessing patients with relapsing-remitting MS. What does this mean for me?
If it doesn’t measure the smouldering disease, why would we want it to be approved? Since the majority of disability isn’t predicted by lesions and relapses (inflammatory disease) this sounds like it would not at all be similar to c-reactive protein in RA. Neurologists are already too focused on radiologic activity, it would be terrible if we now enter an era where neurologists start insisting a patient’s MS is under control just because the sNfL curve is flat…
I have been asking myself whether, when/if the assay works its way through the various Circumlocution Offices to a NICE thumbs-up, whether it may displace or spell the end of the increasingly blunt-looking tool of the annual MRI?
What is my neurofilament level doing?
If it doesn’t measure the smouldering disease, why would we want it to be approved? Since the majority of disability isn’t predicted by lesions and relapses (inflammatory disease) this sounds like it would not at all be similar to c-reactive protein in RA. Neurologists are already too focused on radiologic activity, it would be terrible if we now enter an era where neurologists start insisting a patient’s MS is under control just because the sNfL curve is flat…
I have been asking myself whether, when/if the assay works its way through the various Circumlocution Offices to a NICE thumbs-up, whether it may displace or spell the end of the increasingly blunt-looking tool of the annual MRI?