www.fdanews.com/articles/206872-altpeps-alzheimers-disease-blood-test-designated-a-breakthrough-device
AltPep’s Alzheimer’s Disease Blood Test Designated a Breakthrough Device
March 8, 2022
The FDA has designated Seattle, Wash.-based AltPep’s SOBA-AD diagnostic for Alzheimer’s disease (AD) a Breakthrough Device.
Existing FDA-cleared diagnostic tests for AD look for amyloid-beta plaques and neurofibrillary tangles in the brains of patients, while the SOBA-AD blood test in plasma aims to detect the early molecular triggers of the disease before plaque formation.
The blood test, which is intended to detect the disease before symptoms arise, potentially opens the way for more effective treatments that limit cognitive decline.