NEW YORK – Sysmex said this week it had received manufacturing and marketing approval in Japan for a pair of assay kits to identify elevated amyloid beta concentrations characteristic of Alzheimer's disease.
The Kobe, Japan-based firm said Monday it had received approval form Japan's Pharmaceuticals and Medical Devices Agency for its blood-based HISCL β-Amyloid 1-42 Assay Kit and HISCL β-Amyloid 1-40 Assay Kit, which are designed for use on its automated HISCL-Series immunoassay instruments. The assays measure the ratio of Aβ 1-42 and 1-40 peptides with a chemiluminescence enzyme immunoassay that requires a sample of 10-30 microliters of plasma, and deliver results in 17 minutes.
The firm said the assays provide a less invasive and simpler alternative to conventional methods of diagnosing Alzheimer's disease through Aβ accumulation. Other diagnostic methods for the disease include analysis of cerebrospinal fluid through lumbar puncture, and more recently blood-based tests.
"In recent years, there has been an increase in the development of new therapeutic drugs worldwide that address the underlying pathology of Alzheimer's disease, so testing and diagnosis are becoming even more important for the appropriate use and dissemination of these drugs," the firm said.
Sysmex said it is launching sales while working toward coverage by Japan's national health insurance entity.