Japan approves blood test kit to detect Alzheimer’s as breakthrough therapy is round the corner

Japan, with the world’s highest ratio of elderly, has about six million people with dementia. PHOTO ILLUSTRATION: PEXELS

TOKYO – Japan has approved one of the world’s first blood test kits to detect signs of Alzheimer’s disease, paving the way for a simpler and speedier diagnosis of the brain-wasting ailment for which a blockbuster therapy is finally on the horizon.

Sysmex Corp’s diagnostic product that measures amyloid beta in the blood – an abnormal protein that jams nerve cells in the brain and is a marker of Alzheimer’s – was authorised for use by Japan’s Health Ministry, the Kobe-based firm said in a statement on Thursday.

“We plan to prepare for the early introduction of the product to the market, while working towards its coverage by Japanese national health insurance,” Sysmex said in the statement.

Japan, with the world’s highest proportion of elderly in the population, has about six million people with dementia, according to the Health Ministry. Dementia is a broader category that includes Alzheimer’s.

The blood test kit co-developed with Eisai Co will give doctors in Japan an easy, inexpensive and minimally invasive tool to screen people quickly for the disease, which is currently done through PET scans, MRI or painful spinal taps.

Convenient testing will also help physicians decide who is qualified to receive a novel therapy – the drug lecanemab – being developed by Eisai and Biogen, that may get approved in the US in early 2023.

Screening patients

Eisai’s drug is the first ever therapy to clearly slow the progress of Alzheimer’s – a breakthrough more than 100 years after the telltale signs of the disease were discovered.

After billions of dollars spent in research by healthcare companies over more than 100 experimental failed drugs, the promise around lecanemab is spurring a global rush to make blood test products that can quickly screen patients who should receive the novel treatment once it is approved.

Quest Diagnostics, Quanterix Corp and C2N Diagnostics have also developed blood-based diagnostic products but they have not received approvals from the United States’ Food and Drug Administration (FDA).

Sysmex’s domestic rival, Shimadzu Corp, secured approval in Japan for its blood testing device in 2020 but it is different from Sysmex’s test which is an antibody-based method. This latter method has the advantage, as hospital laboratories are generally equipped to use it.

The diagnostics and therapeutics market for Alzheimer’s disease, the most common form of dementia, is expected to touch US$9.6 billion (S$12.9 billion) by 2027 from US$7 billion in 2021, said the ResearchAndMarkets.com news research site in August.

Alzheimer’s Disease International estimates dementia could affect more than 80 million people globally in 2030 and over 150 million in 2050.

Accelerated approval

That changed after a study published in November showed that lecanemab is able to slow its progression. The FDA is expected to take a decision by early January on Eisai’s request for an accelerated approval of its breakthrough drug after demonstrating the ability to lower amyloid.

If the novel therapy gets FDA’s nod, Eisai plans to quickly submit the trial efficacy data for a full clearance in the US and then file documents for approval in Japan and Europe by March, according to the Tokyo-based company. Sysmex has been in a non-exclusive pact with Eisai since 2016 to create new diagnostics in dementia. It develops and makes instruments, reagents and software needed for in-vitro diagnostics that can detect cancer to chronic diseases. BLOOMBERG

Join ST's Telegram channel and get the latest breaking news delivered to you.