In the rush to tout Amyvid, the amyloid-plaque-seeking biomarker created by Eli Lilly, as a diagnostic breakthrough in the treatment of Alzheimer's disease, some are urging caution — including the Alzheimer's Association.
Amyvid was just approved by the FDA on Friday, yet that celebration was tempered by the refusal of CMS to approve coverage for its prescription. The drug carries a significant warning that it is incomplete as a standalone diagnosis mechanism. , and its own founders reported in the University of Pennsylvania student newspaper that Amyvid can bind to other, unintended particles, complicating the read of the PET scan.
But even if the coverage is longer in coming than expected, and even if the product doesn't work 100% as advertised, said Forbes columnist Matthew Herper its true benefit might be its time to market in advance of those of its competitors.
"Even in the best-case scenario, this isn’t a huge product, financially," Herper said in a recent blog.. From a patient standpoint, however, It still seems preferable to the only failsafe diagnosis method in use for decades: posthumous dissection of the brain.