Labcorp Launches Blood Test to Accelerate Alzheimer's Diagnosis, Joining Race for Early Detection

In a significant development for Alzheimer's disease diagnosis, Labcorp has introduced a blood-based biomarker test in the United States, aiming to support faster and more accessible detection of the neurodegenerative condition. This launch comes as pharmaceutical companies intensify efforts to diagnose and treat Alzheimer's in its early stages, following recent approvals of disease-modifying drugs.

New Blood Test Promises to Streamline Alzheimer's Diagnosis

Labcorp's newly offered immunoassay measures the ratio of two distinct Alzheimer's biomarkers: ptau-217 and beta amyloid 42. The Global CEO Initiative on Alzheimer's Disease (CEOi) has identified ptau-217 as one of the most promising blood-based biomarkers for amyloid status. This test represents a potential shift away from more invasive and less scalable diagnostic methods such as amyloid PET scans and cerebrospinal fluid (CSF) assays.

The company reports that the sensitivity and specificity of the confirmatory test are both 95%, meeting CEOi's acceptable threshold of 90% and higher. Labcorp claims the test's performance is substantially equivalent to FDA-cleared CSF assays and PET imaging methods.

Patients can provide blood samples at their physician's office or at any of Labcorp's over 2,000 patient service centers across the United States, potentially increasing accessibility to diagnosis.

Industry Push for Early Detection and Treatment

The introduction of Labcorp's blood test aligns with a broader industry trend towards accelerating Alzheimer's diagnosis and treatment. This push has gained momentum following the approvals of disease-modifying drugs such as Eisai and Biogen's Leqembi and Eli Lilly's Kisunla, which are indicated for use in patients with early symptoms.

According to Labcorp, the average time between symptom onset and Alzheimer's diagnosis is approximately 2.8 years, though this figure is based on a study published in 2002. The development of blood-based biomarker tests is seen as a way to potentially reduce this diagnostic delay and enable earlier intervention.

Competition Intensifies in Alzheimer's Diagnostics

Labcorp's announcement signals intensifying competition in the Alzheimer's blood test market. Keisuke Naito, chief operating officer at Eisai, recently stated that several diagnostic companies have submitted in vitro diagnostic (IVD) applications for confirmatory testing using high-precision composite scores, including systems that evaluate both A𝛽 and ptau-217.

Roche is also making strides in this area, having received FDA breakthrough designation for a ptau-217 blood test in 2024. Bruno Eschli, head of investor relations at Roche, indicated that ptau-217 will initially be used as a triage test and has the potential to become the first blood-based rule-in test, potentially revolutionizing timely Alzheimer's diagnosis.

As pharmaceutical companies and diagnostic developers race to improve early detection and treatment of Alzheimer's disease, the landscape of neurological diagnostics continues to evolve rapidly. The success of these blood-based tests could significantly impact patient care and the effectiveness of emerging Alzheimer's therapies.