Roche Diagnostics' total-tau CSF test approved for Alzheimer’s in Korea

Roche Diagnostics Korea said its Elecsys Total-Tau CSF (t-Tau) test, a cerebrospinal fluid (CSF) test method for Alzheimer’s disease, has received approval from the Ministry of Food and Drug Safety (MFDS).

With this approval, Roche Diagnostics Korea has completed its cerebrospinal fluid (CSF) test portfolio for Alzheimer’s disease, adding to its previously approved Elecsys β-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau(181P) CSF (pTau181) tests.

Currently, the Abeta42 and pTau181 tests are prescribed at major hospitals across Korea. All three Roche Diagnostics Alzheimer’s tests have also been approved by the U.S. FDA, where CSF analysis and amyloid PET imaging are the only approved methods for confirming amyloid protein buildup, a hallmark of Alzheimer’s.

When used alongside Abeta42 and pTau181, the t-Tau test increases diagnostic accuracy for Alzheimer’s disease, aiding in the detection of mild cognitive impairment (MCI) and early-stage dementia, and providing valuable insights for prognosis.

The t-Tau test can also be used to predict the progression to dementia, even in individuals with normal cognitive function, making it a significant tool for early diagnosis and intervention.

These tests can be performed on all Roche Diagnostics fully automated immunoassay analyzers, which are already installed in numerous medical institutions. This accessibility enhances both the scalability and cost-effectiveness of Alzheimer's diagnostics in Korea.

As Korea’s elderly population rapidly grows, the burden of dementia is increasing. Over the past five years, the number of estimated dementia patients aged 65 and older has risen by approximately 50,000 annually, with nearly one million patients projected in 2023.

By 2070, this number is expected to exceed 3.38 million. Roughly 10-15 percent of individuals with MCI progress to dementia, a rate that is about 12 times higher than that of normal aging. Early diagnosis is critical, as delaying dementia onset by two years could reduce its prevalence by 80 percent in 20 years, while a five-year delay could lower it by 56 percent

Early and accurate diagnosis is also essential for maximizing the effectiveness of disease-modifying therapies (DMTs), which are increasingly being developed and used to slow the progression of Alzheimer's disease.

"Korea is rapidly entering a super-aged society, and the rising socio-economic burden of dementia on healthcare and welfare systems is anticipated," Roche Diagnostics Korea General Manager Kit Tang said. "Timely and precise diagnosis in the early stages of Alzheimer’s disease is crucial to protect both public health and national finances from the risks of dementia.”

Roche Diagnostics will continue to strengthen its Alzheimer’s diagnostic portfolio, not only through CSF testing but also through continued investment in blood-based diagnostic development, Tang added.