Roche and Lilly's Alzheimer's Blood Test Gains FDA Approval, Marking Milestone in Diagnostics

In a significant development for Alzheimer's disease diagnostics, Roche and Eli Lilly have secured FDA clearance for their blood-based biomarker test, Elecsys pTau181. This approval marks a crucial step forward in the early detection and management of Alzheimer's disease, potentially accelerating patient access to emerging therapies.

First Blood Test Approved for Primary Care Use

The Elecsys pTau181 test, designed for patients 55 years and older showing signs of cognitive decline, is the first of its kind approved for use in primary care settings. This breakthrough allows for earlier and more widespread screening, potentially addressing the significant underdiagnosis of mild cognitive impairment, which affects an estimated 92% of patients according to Roche.

Brad Moore, Roche's president and CEO of North American diagnostics, emphasized the test's importance: "By bringing Alzheimer's blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys."

The test measures levels of phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer's pathology. With a 97.9% negative predictive value for ruling out Alzheimer's pathology, Elecsys offers primary care physicians a powerful tool for initial assessment and appropriate referral to specialists.

Potential Impact on Alzheimer's Drug Uptake

The approval of Elecsys could have far-reaching implications for the uptake of recently approved Alzheimer's therapies. Biogen CEO Chris Viehbacher noted that such biomarker-based tests could "remove some of the bottlenecks" in the adoption of treatments like Leqembi, which Biogen developed in partnership with Eisai.

This sentiment aligns with the pharmaceutical industry's push for improved diagnostic capabilities to support the use of new Alzheimer's treatments. Earlier this month, Eli Lilly called for urgent improvements in European countries' Alzheimer's disease diagnostic testing practices, following the approval of its therapy Kisunla in the region.

Recent Advances in Alzheimer's Treatment Landscape

The diagnostic breakthrough comes amid a series of regulatory wins in the Alzheimer's space. Notable developments include:

• FDA approval of Biogen and Eisai's subcutaneous Leqembi (branded as Leqembi Iqlik) for maintenance therapy in patients who have been on intravenous Leqembi for at least 18 months.
• Eli Lilly's Kisunla securing a label expansion for a more gradual dosing schedule, potentially reducing the risk of amyloid-related imaging abnormalities.
• Long-term efficacy data for Kisunla, demonstrating its ability to keep amyloid plaques at bay for up to 2.5 years.

These advancements, coupled with improved diagnostic capabilities, signal a new era in Alzheimer's disease management, offering hope for earlier intervention and more personalized treatment approaches.