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Japan’s Sysmex Corp says it has received regulatory approval in Japan for a blood test to detect amyloid beta in the brain, a characteristic of Alzheimer’s disease.
The company developed the test with Japanese drugmaker Eisai Co and gained approval from regulators on December 19, it said in a statement on Thursday.
The test kit is being seen as a rare advance in tackling a condition that affects tens of millions worldwide.
The kit uses a small amount of the patient’s blood to measure amyloid beta accumulation in the brain, allowing for earlier diagnosis and treatment.
Sysmex, a maker of medical equipment and clinical tests, said it was preparing for market introduction as soon as possible.
Eisai and its United States-based partner Biogen Inc are planning to seek full approval of their experimental Alzheimer’s drug lecanemab in the US, Europe and Japan next year.
Current existing methods of diagnosing Alzheimer’s are expensive and medically intrusive, often involving a brain scan or spinal tap.
“Sysmex has been developing a technology to more quickly and readily identify the accumulation of [amyloid beta] in the brain in order to solve issues in the diagnosis of Alzheimer’s disease,” the company said.
“Unlike conventional testing methods … [the kit] allows testing with blood, thus reducing the physical, emotional, and financial burden on patients,” it added.
The US-based Alzheimer’s Association says “an urgent need exists for simple, inexpensive, non-invasive and easily available diagnostic tools such as blood tests to diagnose the disease”.
“In the future, they are very likely to revolutionise the diagnostic process for Alzheimer’s and all other dementia,” the group says on its website.
Data showed last month that a new drug called lecanemab slowed cognitive decline in Alzheimer’s patients by 27 percent across an 18-month period.
The drug also appeared to have adverse effects including brain bleeds and swelling but was largely hailed as offering a “real treatment option” for those with degenerative cognitive disease.
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
