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 together with Japanese drugmaker Eisai Co and received regulatory approval on December 19, it said in a statement on Thursday.
The test kit is seen as a rare advance in fighting a disease that affects tens of millions of people worldwide.
The kit uses a small amount of the patient’s blood to measure amyloid beta accumulation in the brain, allowing earlier diagnosis and treatment.
Sysmex, a manufacturer of medical devices and clinical tests, says it is preparing for the imminent launch.
Eisai and its US-based partner Biogen Inc. plan to apply for full approval of their experimental Alzheimer’s drug lecanemab in the USA, Europe and Japan next year.
Presently
Existing methods for diagnosing Alzheimer’s are expensive and medically complex and often include a brain scan or a lumbar puncture.
“Sysmex has developed technology to identify the accumulation of [amyloid beta] in the brain more quickly and easily to solve problems in diagnosing Alzheimer’s disease,” the company said.
“Unlike traditional testing methods… [the kit] allows blood tests, reducing the physical, emotional and financial burden on patients,” it added.
The US-based Alzheimer’s Association says that “there is an urgent need for simple, inexpensive, noninvasive, and readily available diagnostic tools, such as blood tests, to diagnose the disease.”
“In the future, they are very likely to revolutionize the diagnosis process for Alzheimer’s and all other forms of dementia,” says the group’s website.
Data showed last month that a new drug called lecanemab slowed cognitive decline in Alzheimer’s patients by 27 percent over an 18-month period.
The drug also appeared to have side effects, such as cerebral hemorrhages and swelling, but was widely hailed as a “real treatment option” for people with degenerative cognitive disorders.
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up to form matts and plaques, which are collectively known as aggregates, which cause brain cells to die and cause brain shrinkage.