The news: A new Alzheimer’s blood test from Eli Lilly and Roche is the third to receive FDA clearance in just over a year, showing growing momentum for blood testing in Alzheimer’s diagnostics. For context, the companies also developed one of the two earlier tests cleared in October; Fujirebio developed the first, cleared in May 2025. Quest Diagnostics and Labcorp both plan to offer the new test. Quest will add it in Q4, while Labcorp is planning a nationwide rollout in the coming months.

Why it matters: Blood tests could make initial Alzheimer’s assessment more accessible than the current methods for detecting the disease’s diagnostic marker, amyloid plaque buildup in the brain, which are more complex and invasive. Positron emission tomography (PET) brain scans require specialized imaging, while cerebrospinal fluid testing requires a spinal tap.

Amyloid confirmation is the gate to treatment: the only two FDA-approved drugs that slow Alzheimer’s progression, Eisai and Biogen’s Leqembi and Lilly’s Kisunla, both require it before treatment can begin. An estimated 7.4 million US adults ages 65+ are living with Alzheimer’s, along with another 200,000 ages 30 to 64 with younger-onset disease. But the Alzheimer’s Association estimates that 19 million adults ages 65+, about 30% of that age group, are on the biological continuum of Alzheimer’s, ranging from silent biomarker changes to severe clinical symptoms. Wider blood testing could pull more of that group into evaluation, starting with those already showing symptoms.

Implications for pharma companies and healthcare systems: Blood tests could take Alzheimer’s detection out of the specialists’ office. It reduces reliance on more complex PET scans and spinal taps, and the broad planned adoption by Quest and Labcorp could widen access further. Routine primary care would become the starting point.

A positive result does not automatically establish a diagnosis or treatment eligibility, even as wider testing expands the pool of patients evaluated for treatment. This shifts the burden to the primary care physicians taking on more of the initial workup: result interpretation, patient counseling, specialist referrals, and treatment access. Educational resources for healthcare providers can clarify which patients are appropriate for testing, what the results mean, and when specialist follow-up is needed.

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