Amyloid testing reaches a limited market

Never let it be said that the FDA does not have a sense of timing. Two days after Biogen pretty much gave up on its anti-amyloid drug Aduhelm, the US regulator has granted de novo clearance to the first in vitro diagnostic for amyloid plaques. The Lumipulse G β-Amyloid Ratio (1-42/1-40) test, made by Fujirebio, may now be used for patients aged 55 and older who have cognitive impairment and are being evaluated for Alzheimer’s disease. The Lumipulse test measures the ratio of two different β-amyloid fragments, 1-42 and 1-40, in cerebral spinal fluid. β-amyloid 1-42 is generally recognised as one of the major constituents of amyloid plaques. While the commercial failure of Aduhelm means that short-term uptake of Lumipulse might not be as good as it could have been, the test could still find a niche. Amyloid is used as a diagnostic criterion for Alzheimer’s, and this test might take the place of more expensive and hazardous PET scans. That said, a lumbar puncture is still fairly invasive. Perhaps Lumipulse’s best chance of ramping sales will come if another β-amyloid MAb gains approval; Lilly’s donanemab and Eisai/Biogen's lecanemab face regulatory decisions this year.