Roche Diagnostics 'Dementia Diagnostic Test'... Supplied to GC Green Cross Medical Foundation

Roche Diagnostics Korea announced on the 29th that the Elecsys Beta-Amyloid (1-42) CSF II and Elecsys Phosphorylated Tau (181P) CSF analysis tests for Alzheimer's disease diagnosis have been introduced at GC Green Cross Medical Foundation, a major specialized testing institution.

GC Green Cross Medical Foundation is conducting Alzheimer's disease cerebrospinal fluid (CSF) testing using the Cobas e801 analyzer from Roche Diagnostics Korea.
[Photo by Roche Diagnostics Korea]

With this introduction, patients who wish to undergo cerebrospinal fluid (CSF) testing can have their samples collected at medical institutions nationwide and then request testing through GC Green Cross Medical Foundation. These tests were approved by the U.S. Food and Drug Administration (FDA) in December 2022 and subsequently authorized by the Ministry of Food and Drug Safety in July last year, leading to their release in Korea.

Accurate diagnosis at the early stages of Alzheimer's dementia is crucial to significantly enhance the effectiveness of treatment. Recently approved disease-modifying therapies (DMTs) for Alzheimer's disease, such as Eisai and Biogen’s Leqembi, must be used after precise early diagnosis to maximize their ability to delay disease progression.

Roche Diagnostics’ two Elecsys analysis tests utilize amyloid-beta and tau proteins, which accumulate in the brain tissue of Alzheimer's patients, as biomarkers to aid in diagnosing cognitive impairment caused by Alzheimer's disease. By measuring the concentration and ratio of these two proteins in cerebrospinal fluid, the tests assist in timely diagnosis of Alzheimer's dementia and support clinicians’ clinical decision-making regarding treatment direction. The analysis tests are performed using Roche Diagnostics’ Cobas fully automated immunoassay analyzers.

Currently, the FDA only approves CSF testing and amyloid positron emission tomography (PET) scans to confirm the accumulation of amyloid proteins, the causative agents of Alzheimer's disease. However, PET scans have limitations such as long diagnostic times and the need to inject radioactive pharmaceuticals into patients.

Roche Diagnostics explained, "The two Elecsys analysis tests can detect both amyloid and tau protein biomarkers in a single test without radiation exposure, requiring less time and cost compared to PET scans." They added, "The tests show a high positive agreement rate (90.9%) and negative agreement rate (89.2%) with existing amyloid PET scan results, enhancing diagnostic accessibility for patients as a new option for confirming amyloid pathology."

Dr. Ahn Sun-hyun, a specialist in diagnostic laboratory medicine at GC Green Cross Medical Foundation, said, “Since timely treatment through rapid diagnosis is critical for Alzheimer's disease, GC Green Cross Medical Foundation decided to quickly adopt Roche Diagnostics’ two Elecsys analysis tests following their approval.” He added, “From the patient’s convenience perspective, the tests have lower costs, shorter waiting times for testing and results, and improve the differential accuracy of mild cognitive impairment, which is expected to strengthen dementia prevention and treatment.”

Kit Tang, CEO of Roche Diagnostics Korea, also stated, “With the introduction of the two Elecsys analysis tests at GC Green Cross Medical Foundation, we hope many patients in Korea will be able to receive rapid and accurate Alzheimer's disease diagnoses and successful treatments.” He continued, “Roche Diagnostics will continue its efforts to improve the Alzheimer's diagnostic environment in Korea and enhance patients’ access to testing.”