China Approves the First Cerebrospinal Fluid Test Panel for Alzheimer’s Disease

Roche Diagnostics’ Elecsys® Alzheimer’s disease (AD) cerebrospinal fluid (CSF) test panel has received approval from the National Medical Products Administration (NMPA) for market launch in China. This marks the first in vitro diagnostic (IVD) product in China’s neurology field to be granted Priority Review status, and it is currently the only CSF-based AD test panel approved for clinical diagnosis in the country.

This milestone is expected to enable earlier and more accurate identification of AD, accelerating the development of a new ecosystem for early diagnosis and early intervention in China.

Seizing the “Golden Window” for Early AD Intervention

China is home to nearly 17 million people living with dementia, of whom an estimated 63–70% are affected by Alzheimer’s disease. As population aging accelerates, the number of AD patients continues to rise, making it a major disease that significantly impacts public health and survival.

Despite its high prevalence, AD in China is characterized by low awareness, low diagnosis rates, and low treatment rates. Many patients are diagnosed only at the middle or late stages of the disease, missing the optimal window for intervention.

Globally, AD diagnosis is shifting from reliance on clinical symptoms alone to an integrated approach that incorporates biomarker evidence. This approach typically includes medical history, cognitive assessments, routine laboratory tests, structural imaging (MRI/CT), and amyloid beta (Aβ) positron emission tomography (PET). While Aβ-PET is an important assessment tool, its high cost, limited accessibility, and radiation exposure restrict widespread use. There is therefore an urgent clinical need for a diagnostic solution that combines high accuracy, broad accessibility, and cost-effectiveness.

CSF Testing Redefines the “Gold Standard” for AD Diagnosis

The approval of the Elecsys® AD CSF test panel directly addresses this unmet clinical need. The test offers key advantages including higher cost-effectiveness, wider accessibility, and no radiation exposure. Importantly, it can detect Alzheimer’s pathology before amyloid plaques become visible on imaging, enabling much earlier disease identification and potentially shortening the diagnostic timeline by months or even years.

• Core Pathological Biomarkers
  The test directly quantifies three core AD biomarkers in human cerebrospinal fluid—Aβ42, phosphorylated Tau (pTau181), and total Tau (tTau). It demonstrates up to 90% concordance with Aβ-PET results and is widely recognized as a “gold standard” for AD diagnosis, particularly in the early stages.
• Value in Ultra-Early Prediction
  Changes in CSF biomarkers can occur 15–20 years before the onset of clinical symptoms, with alterations in Aβ42 appearing even earlier than those detectable by Aβ-PET imaging.
• Strong Endorsement by Guidelines and Expert Consensus
  The latest international and Chinese guidelines and expert consensuses recognize the value of CSF biomarker testing in early diagnosis, differential diagnosis, and disease progression assessment of AD. CSF biomarkers are also recommended as key criteria for initiating disease-modifying therapies (DMTs). In contrast, blood-based biomarkers still require confirmation by Aβ-PET or CSF testing.

Richard Yiu, General Manager of Roche Diagnostics China, commented: “Alzheimer’s disease places an enormous burden on individuals, families, and society. For more than two decades, Roche has been deeply committed to Alzheimer’s research, striving to advance early detection, precise diagnosis, and innovative treatment. The approval of the Elecsys® AD CSF test panel represents a cornerstone in Roche Diagnostics’ efforts to support the development of China’s AD prevention and treatment system. Looking ahead, we will continue to accelerate access to innovative solutions, empowering clinicians to intervene earlier and more precisely, so that patients can benefit from cutting-edge diagnostic and therapeutic advances and ultimately achieve a better quality of life.”