Fujirebio has been developing tests for Alzheimer’s disease for decades, but it wasn’t until May 2025 that it received approval from the U.S. Food and Drug Administration (FDA) for the first Alzheimer’s blood test. Previous tests relied on detecting markers of Alzheimer’s proteins in cerebrospinal fluid—often requiring a lumbar puncture—but the latest test looks for the ratio between two hallmark disease proteins in blood, offering a less invasive option and the opportunity for more patients to be diagnosed early and potentially benefit from treatment.
Goki Ishikawa, who will become Fujirebio’s new president and group CEO in April, will face challenges in establishing the new test in real-world lab settings; at a conference of experts in December, doctors raised concerns about the test’s high false positive rate. But the test marks a significant step toward better screening options that will help doctors and patients detect the disease earlier.