Advances in Diagnosis Alongside Dementia Drug Development... Roche Diagnostics Receives Approval for Cerebrospinal Fluid Testing

Roche Diagnostics Korea announced on the 26th that its cerebrospinal fluid (CSF) analysis tests related to Alzheimer's disease, ‘Elecsys Beta-Amyloid (β-Amyloid)(1-42) CSF II’ and ‘Elecsys Phospho-Tau (Phospho-Tau)(181P) CSF’, were approved by the Ministry of Food and Drug Safety on the 25th. These tests had previously received approval from the U.S. Food and Drug Administration (FDA) in December last year.

Roche Diagnostics' 'Elecsys Beta-Amyloid (β-Amyloid) (1-42) CSF II'
[Photo by Roche Diagnostics]

The Elecsys Aβ (beta)42 and pTau (Tau)181 analysis tests measure amyloid beta (Aβ)42 and phosphorylated tau (pTau)181 proteins, which are suspected causes of Alzheimer's disease, and are used in CSF analysis to aid in the diagnosis of cognitive impairment caused by Alzheimer's disease. By using Aβ and tau proteins, which accumulate in the brain tissue of Alzheimer's patients, as biomarkers, the concentration of these two substances is measured in cerebrospinal fluid and their ratio is calculated to assist in diagnosing cognitive impairment due to Alzheimer's disease. This helps facilitate timely diagnosis of Alzheimer's dementia and supports clinical decision-making by healthcare professionals regarding treatment directions.

These tests can be performed on all Roche Diagnostics' cobas fully automated immunoassay analyzers, including cobas e 801, cobas e 601, and cobas e 402, offering high scalability and cost-effectiveness, thereby improving broad patient access to high-quality testing.

Alzheimer's disease is a degenerative brain disorder characterized by the gradual destruction of brain cells and reduction of brain tissue due to abnormal protein deposits such as amyloid plaques in the brain, leading to loss of brain function. It is considered the most common cause of dementia. According to the Central Dementia Center, approximately 70% of the estimated 935,000 dementia patients aged 65 and older in South Korea are believed to have Alzheimer's disease. Diagnosis typically involves neuropsychological tests, blood tests, electroencephalography, brain imaging, and genetic testing, but it can take several years to confirm an accurate diagnosis.

However, since brain function damaged by Alzheimer's disease cannot be restored, early and rapid diagnosis is crucial to begin treatment and management as soon as possible. Especially for recently developed and actively used disease-modifying therapies (DMTs) such as Biogen and Eisai's 'Leqembi' (active ingredient lecanemab) and Eli Lilly's 'Donanemab', which delay disease progression, accurate early-stage diagnosis is essential to maximize their effectiveness.

[Photo by Korea Roche Diagnostics]

Until now, amyloid positron emission tomography (PET) was the only method used for early diagnosis of Alzheimer's disease, but with the introduction of Roche Diagnostics' Elecsys tests, which can identify pathological changes using specific biomarkers, options for early diagnosis of Alzheimer's disease have diversified. Currently, the only FDA-approved tests for confirming amyloid protein accumulation are amyloid PET and CSF analysis.

In particular, CSF analysis using Roche Diagnostics' Elecsys tests shows a high concordance with existing amyloid PET test results, providing a new option for confirming amyloid pathology and improving patient access to diagnosis. Since it can detect both biomarkers, Aβ and tau proteins, in a single analysis without radiation exposure, it offers advantages in terms of time and cost compared to PET scans. Until now, multiple PET scans were required to confirm both proteins, which increased radiation exposure and posed limitations.

Kit Tang, CEO of Roche Diagnostics Korea, said, “We hope that CSF analysis using Roche Diagnostics' Elecsys tests will become a meaningful diagnostic method for Alzheimer's patients to receive appropriate treatment at the right time. Through this approval by the Ministry of Food and Drug Safety, Roche Diagnostics Korea will do its best to support effective early diagnosis and response for Alzheimer's patients and healthcare professionals in South Korea.”

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