Roche Diagnostics Korea said on Wednesday that two of its Alzhimer’s disease cerebrospinal fluid (CSF) tests won approval from the Ministry of Food and Drug Safety (MFDS). 

The two tests were approved by the U.S. FDA in December 2022.

The Elecsys β-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assay measures the Abeta42 and pTau181 proteins, which are believed to cause Alzheimer's disease. It is also used to analyze cerebrospinal fluid (CSF) to help diagnose cognitive impairment caused by Alzheimer's disease. 

Using beta-amyloid and tau proteins as biomarkers that accumulate in the brain tissue of patients with Alzheimer's disease, the concentration of these proteins in the CSF can be measured to aid in the timely diagnosis of Alzheimer's disease and support clinicians' treatment decision-making. 

The test is compatible with all of Roche Diagnostics' COBAS fully automated immunoassay instruments, including the COBAS E 801, COBAS E 601, and COBAS E 402.

Alzheimer's disease is a degenerative brain disorder characterized by the buildup of abnormal proteins such as amyloid plaques in the brain, which gradually destroys brain cells resulting in the loss of brain function. According to the Korea Dementia Research Center, Alzheimer’s disease accounts for 70 percent of the estimated 935,000 dementia patients over the age of 65 in Korea. 

Currently, amyloid positron emission tomography (PET) has been the only method used for the early diagnosis of Alzheimer's disease, but the introduction of Roche Diagnostics' Elecsys Abeta42 and pTau181 assays, which use specific biomarkers to identify pathological changes, has expanded the options for early diagnosis of Alzheimer's disease.

Furthermore, the assays offer the detection of both amyloid and tau proteins, in a single assay without radiation exposure, which is less time-consuming and less expensive than a PET scan. 

"We hope that our CSF assays will become a meaningful diagnostic tool for patients with Alzheimer's disease to receive the right treatment at the right time," said Roche Diagnostics Korea CEO Kit Tang, "We will make every effort to support effective early diagnosis and response for patients with Alzheimer's disease in Korea."