Japan approved one of the world’s first blood test kit to detect signs of Alzheimer’s disease, paving 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 authorized 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 toward its coverage by Japanese national health insurance,” Sysmex said in the statement. Japan, with the world’s highest ratio of elderly, has about 6 million people with dementia, according 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’s qualified to receive a novel therapy — lecanemab — being developed by Eisai and Biogen Inc., that may get approved in the US early next year.
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 health care 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’s approved.
Quest Diagnostics Inc., Quanterix Corp. and C2N Diagnostics have also developed blood-based diagnostic products but they haven’t received approvals from the US Food and Drug Administration.
Sysmex’s domestic rival, Shimadzu Corp., secured approval in Japan for its blood testing device in 2020 but it’s different from Sysmex’s test which is an antibody-based method. This method has the advantage that laboratories inside hospitals 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 $9.6 billion by 2027 from $7 billion in 2021, ResearchAndMarkets said in August. Alzheimer’s Disease International estimates dementia could affect more than 80 million people globally in 2030 and over 150 million in 2050.
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.
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