FDA approval for first in vitro diagnostic for early Alzheimer’s detection

The US FDA has approved the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD). The Lumipulse G ?-Amyloid Ratio (1-42/1-40) test, from Fujirebio Diagnostics, detects amyloid plaques associated with AD in adults aged 55 or older.

The test has been approved for adults who are under investigation for AD, and other causes of cognitive decline. The FDA shared that the test minimises radiation risks to patients who would otherwise need to be tested with positron emission tomography (PET) scans.

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