Roche wins FDA clearance for Elecsys pTau217 Alzheimer's blood test
核心洞察
F. Hoffmann-La Roche (搜索) has received FDA 510(k) clearance for its Elecsys pTau217 (搜索) blood test, which supports identification of amyloid pathology associated with Alzheimer's disease (搜索).
Roche Diagnostics K.K. (搜索) said in a September 11 release that the parent company published an investor update on August 24 regarding the clearance.
Elecsys pTau217 (搜索) is under application in Japan and remains unapproved there, with the Japanese unit noting the notice was not promotion, advertising or medical advice.
F. Hoffmann-La Roche (搜索) has obtained U.S. Food and Drug Administration 510(k) clearance for its Elecsys pTau217 (搜索) blood test, which is designed to support identification of amyloid pathology associated with Alzheimer's disease (搜索). Roche Diagnostics K.K. (搜索) disclosed the clearance in a release dated September 11, stating that the parent company had published an investor update on August 24 covering the FDA decision.
The clearance was granted under the FDA's 510(k) pathway, a U.S. regulatory process for medical devices cleared on the basis of substantial equivalence to legally marketed products. Amyloid pathology refers to abnormal amyloid protein (搜索) accumulation in the brain and is one of the biological features associated with Alzheimer's disease (搜索).
Elecsys pTau217 (搜索) is currently under application in Japan and remains unapproved in the country. Roche Diagnostics K.K. (搜索) said the notice was intended to provide the latest information on Roche to stakeholders in Japan and was not meant as promotion, advertising or medical advice. Blood-based testing for Alzheimer's-related biomarkers has drawn increasing attention as drugmakers and diagnostic companies seek less invasive tools that could complement established methods such as positron emission tomography scans and cerebrospinal fluid testing.
Source: IBTimes JP