The first-ever blood test for Alzheimer’s disease is set to become available in the United States by late June, following recent regulatory approval. This groundbreaking test, developed by the Japanese company Fujirebio Diagnostics Inc., aims to simplify the diagnosis process for the nearly 7 million Americans affected by this debilitating condition. Goki Ishikawa, head of Fujirebio, confirmed the news in an interview on Tuesday, emphasizing the test's significance in early detection and treatment.
Initially, the Alzheimer’s blood test will be offered at approximately 50 specialized research institutes and hospitals across the U.S. These facilities focus on the diagnosis and treatment of Alzheimer’s disease. As part of its commitment to advancing healthcare, Fujirebio is also collaborating with larger companies, including Beckman Coulter Inc., to facilitate the development and manufacturing of this innovative testing method.
Last week, the Food and Drug Administration (FDA) granted clearance for this blood test, marking a pivotal moment in the fight against Alzheimer’s disease. The test is specifically designed for individuals aged 55 and older who show early signs of the disease. Its primary function is to detect amyloid proteins, which are known to accumulate in the brains of Alzheimer’s patients, serving as a key indicator of the disease.
The entire process of obtaining a diagnosis from this blood test takes roughly 30 minutes, from blood draw to result, and is significantly less expensive than a traditional PET scan. This innovative approach is expected to enhance patient access to new Alzheimer’s treatments, which have thus far been limited by the high costs and invasiveness of existing diagnostic methods.
The introduction of this blood test is anticipated to accelerate the rollout of new Alzheimer’s medications, such as Leqembi from Eisai Co. and Biogen Inc., as well as Kisunla from Eli Lilly & Co. Previously, patients often had to rely on specialized PET scans or cerebrospinal fluid tests, which are both more costly and invasive. By providing a simpler and more affordable testing option, Fujirebio aims to streamline the diagnostic process and improve treatment accessibility for patients.
Fujirebio is not stopping at the U.S. market. Ishikawa indicated that the company plans to submit data for approvals in Japan as early as August and throughout Europe later this year. Additionally, a partner in China is expected to submit regulatory data next year, while Fujirebio collaborates with Agappe Diagnostics Ltd. in India.
“While we have a presence in Japan, expanding into overseas markets requires strategic partnerships,” Ishikawa explained. “By supplying raw materials to our partners, we aim to capture market shares that we could not achieve alone.”
The upcoming launch of this blood test for Alzheimer’s signifies a major advancement in the field of neurology and patient care. With its potential to transform the diagnostic landscape and facilitate earlier treatment, this innovation is poised to have a lasting impact on the lives of millions affected by Alzheimer’s disease.
