Sysmex has received manufacturing and marketing approval for its in-vitro diagnostic test to detect amyloid beta (Aβ) accumulation in the brain, which is an indicator of Alzheimer’s disease.
The test, HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit, uses a small amount of blood sample for measuring the Aβ levels using the company’s automated immunoassay system HISCL-5000/HISCL-800.
The company’s HISCL-Series uses chemiluminescence enzyme immunoassay (CLEIA) as its measurement principle.
The HISCL-Series uses 10 to 30μL of blood and provides results in 17 minutes. It also helps in improving the efficiency and standardising the testing.
Sysmex’s new test measures the ratio of Aβ peptides (the 1-42 peptide and 1-40 peptide) in the blood to determine the Aβ accumulation in the brain.
This facilitates the earlier diagnosis and optimal treatment for patients, which is essential for the treatment of Alzheimer’s disease.
Sysmex is preparing to launch the minimally invasive and simple test in Japan market, as soon as possible.
It stated that the new HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit enables testing with blood, unlike other traditional testing methods.
This reduces the physical, and financial burden on patients who are suspected of Aβ accumulation in the brain.
According to Sysmex, Alzheimer’s disease is the most common form of dementia and accounts for nearly 60% to 70% of all cases.
It is caused by accumulation of Aβ peptides in the brain. This causes damage to the nerve cells, which cannot be regenerated once damaged.
The company stated that the diagnosis of Alzheimer’s disease requires advanced technology to identify the accumulation of Aβ in the brain.