Roche Diagnostics Launches All Three Cerebrospinal Fluid Tests for Dementia Diagnosis

Roche Diagnostics Korea recently announced on the 4th that the Elecsys Total-Tau (t-Tau) cerebrospinal fluid (CSF) analysis test has been approved by the Ministry of Food and Drug Safety (MFDS).

Three types of Alzheimer's disease cerebrospinal fluid analysis tests by Roche Diagnostics Korea
[Photo by Roche Diagnostics Korea]

With this approval, Roche Diagnostics Korea has completed a portfolio of three Alzheimer's disease CSF analysis tests, including the Elecsys Beta-Amyloid (1-42) CSF II and Elecsys Phosphorylated-Tau (pTau) (181P) CSF analysis tests, which were approved by the MFDS last year. All three products are FDA-approved in the United States, and the Beta-Amyloid 42 and pTau 181 tests are currently prescribed at numerous university hospitals in Korea. The FDA only approves CSF analysis and amyloid positron emission tomography (PET) scans as tests to confirm the accumulation of amyloid protein, which is considered a major causative substance of Alzheimer's dementia.

The company explained that using t-Tau together with Beta-Amyloid 42 and pTau 181 improves the accuracy of Alzheimer's disease diagnosis and is useful for diagnosing and predicting the prognosis of mild cognitive impairment and mild dementia. They also added that it is significant because it can be used to assess neuronal damage and predict progression to dementia even in individuals with normal cognitive function.

In particular, the test can be performed on Roche Diagnostics' Cobas fully automated immunoassay analyzers, which are already installed in many medical institutions, offering high scalability and cost-effectiveness. Over the past five years, the estimated number of dementia patients aged 65 and older in Korea has increased by about 50,000 annually, approaching 1 million in 2023 and expected to exceed 3.38 million by 2070. Among patients with mild cognitive impairment, considered a pre-dementia stage, about 10-15% progress to dementia, which is approximately 12 times higher than the rate of progression through normal aging. However, because mild cognitive impairment is often indistinguishable from normal aging signs, many cases miss the golden window for treatment.

Dementia's early diagnosis is critically important, as delaying onset by 2 years can reduce dementia prevalence to about 80% after 20 years, and delaying by 5 years can reduce it to about 56%. Disease-modifying therapies (DMTs) for Alzheimer's disease, which have been actively developed and recently started to be used to delay progression, require accurate early-stage diagnosis to maximize their effectiveness.

Kit Tang, CEO of Roche Diagnostics Korea, stated, “As Korea enters a super-aged society, a rapid increase in the socioeconomic burden related to healthcare and welfare due to dementia is expected. Therefore, rapid and accurate diagnosis at the early stages of Alzheimer's disease is essential to protect the health of the public and national finances from dementia risk.” He added, “Roche Diagnostics will continue to strengthen its Alzheimer's disease diagnostic portfolio through ongoing investment not only in CSF tests but also in the development of blood-based tests for Alzheimer's disease.”

This content was produced with the assistance of AI translation services.