Pursuit to Introduce Fujirebio's FDA-Authorized Alzheimer's Blood Examination

Pursuit to Introduce Fujirebio's FDA-Authorized Alzheimer's Blood Examination

Fujirebio's FDA-Cleared Alzheimer's Blood Test Offers Improved Diagnostic Accuracy

Fujirebio's Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test, a blood test for detecting Alzheimer's disease pathology, has received FDA clearance and shown promising results in a clinical study of 499 patients.

The study, which closely mirrors US demographics, demonstrates a 92% positive predictive value (PPV) and 97% negative predictive value (NPV) for the test. This means that the test correctly identifies 92% of people with Alzheimer's disease and 97% of those without the disease.

This test measures blood levels of phosphorylated tau protein (pTau 217) and amyloid beta 1-42, key proteins involved in Alzheimer's. It provides a less invasive and more accessible alternative to amyloid PET scans and cerebrospinal fluid testing.

In contrast, Quest Diagnostics’ existing laboratory-developed tests (LDTs), part of their AD-Detect™ portfolio, assess plasma amyloid beta 42 and 40 ratios to evaluate Alzheimer’s risk but are not FDA-cleared and may have more limited clinical validation compared to the Fujirebio test.

The Fujirebio test adds an FDA-approved, clinically validated option for specialized care settings, potentially improving diagnostic accuracy and early detection.

Clinical Implications

• The FDA-cleared Fujirebio test enables earlier and more reliable detection of Alzheimer's pathology, which is critical as new disease-modifying treatments are more effective in early stages.
• With high PPV and NPV, it offers strong confidence in ruling in or out Alzheimer's in patients with cognitive symptoms, reducing the need for more invasive diagnostic procedures.
• Integrated into Quest’s broad patient access network (~8,000 locations), it expands access to advanced diagnostics in both clinical and research contexts.
• The addition of this FDA-cleared test complements existing lab-developed assays, enabling clinicians to tailor testing choices based on setting, patient risk, and required regulatory status.

Impact on the Diagnostic Landscape

The clinical lab plans to make Fujirebio's Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test available for use by physicians and researchers this summer. This development could significantly change the diagnostic landscape for Alzheimer's disease, offering a more accessible and scalable alternative to existing diagnostic methods.

Quest Diagnostics is planning to offer laboratory testing based on Fujirebio Diagnostics' FDA-authorized Alzheimer's disease blood test. This move could further solidify the test's position as a leading diagnostic tool for Alzheimer's disease.

Primary care physicians are using Quest's LDT to determine whether a patient should be referred to a neurologist, addressing the issue of getting a referral into a neurologist, which is often a significant challenge in Alzheimer's disease diagnosis.

Blood tests could eventually eliminate the need for PET scans in some patients, making diagnosis more accessible and less costly. This development could revolutionize the way Alzheimer's disease is diagnosed and managed, offering hope for earlier intervention and improved patient outcomes.

References: [1] Fujirebio Diagnostics Inc. (2025). Press Release: FDA Clears First Blood Test to Aid in the Diagnosis of Alzheimer's. [2] Taylor, N. P. (2025). FDA clears first blood test to aid Alzheimer's diagnosis. [3] Alzheimer's Association. (2025). What are biomarkers? [4] Quest Diagnostics. (2025). AD-Detect™: Alzheimer's Disease Diagnostic Testing.

1. The FDA-cleared Fujirebio test, a blood test for detecting Alzheimer's disease pathology, could revolutionize the way Alzheimer's disease is diagnosed and managed, offering hope for earlier intervention and improved patient outcomes.
2. The diagnostic landscape for Alzheimer's disease may significantly change with the availability of Fujirebio's Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test, offering a more accessible and scalable alternative to existing diagnostic methods.
3. Primary care physicians may use Quest Diagnostics' laboratory testing based on Fujirebio Diagnostics' FDA-authorized Alzheimer's disease blood test to determine whether a patient should be referred to a neurologist, addressing the issue of getting a referral into a neurologist, which is often a significant challenge in Alzheimer's disease diagnosis.
4. With high positive predictive value (PPV) and negative predictive value (NPV), the Fujirebio test offers strong confidence in ruling in or out Alzheimer's in patients with cognitive symptoms, reducing the need for more invasive diagnostic procedures.
5. In the realm of medtech and health-and-wellness, the integration of Fujirebio's test into Quest’s broad patient access network (~8,000 locations) expands access to advanced diagnostics in both clinical and research contexts.
6. As new disease-modifying treatments are more effective in early stages, the early and reliable detection of Alzheimer's pathology enabled by the FDA-cleared Fujirebio test is critical for improving patient outcomes.
7. Integrated AI and analytics in the medical field can help in the research and development of therapies and treatments for Alzheimer's disease and other neurological disorders, such as the interpretation of test results for better patient management.

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