WASHINGTON – The first blood test to help diagnose Alzheimer’s disease will be available from late June in the US following regulatory clearance for its use last week, according to the Japanese company behind the innovation.

The test will initially be available at about 50 American research institutes and hospitals that specialise in the disease, said Mr Goki Ishikawa, head of Fujirebio Holdings Inc, a unit of Japan’s H.U. Group Holdings Inc, in an interview on May 20.

The firm is partnering with bigger rivals like Beckman Coulter Inc to help develop and manufacture its products, he said.

Last week, the US Food and Drug Administration cleared the blood test, which will help diagnose Alzheimer’s disease, potentially making it easier to find and treat patients with the memory-robbing disease that affects nearly seven million Americans.

The test was cleared for use in people aged at least 55 and who exhibit signs of the disease.

It is designed to detect amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer’s, the most common form of dementia in the elderly. 

The process, which takes roughly 30 minutes from drawing of blood to diagnosis, will be available to patients at a fraction of the cost of a positron emission tomography (PET) scan.

The method is viewed as a critical step in making new types of Alzheimer’s treatments widely accessible.

Until now, patients typically have to get a specialised PET scan to detect amyloid in their brains or undergo cerebrospinal fluid tests, both of which are more expensive and invasive.

The lack of quick and easy tests has until now slowed the roll-out of new Alzheimer’s drugs such as Eisai Co and Biogen Inc’s Leqembi, and Eli Lilly & Co’s Kisunla.

Fujirebio Holdings plans to file data to seek approvals in Japan as early as in August, and in Europe within 2025, Mr Ishikawa said.

In China, Fujirebio’s undisclosed partner will probably submit data to regulators in 2026, he added.

The company’s partner in India, Agappe Diagnostics, has already filed data to seek clearance in the country, according to Mr Ishikawa.  

“We have a presence in Japan but that’s not necessarily the case in markets overseas,” he said. “We can’t get the market shares by ourselves, but if we supply the raw materials to partners, we can benefit through them.” BLOOMBERG

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