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FDA approves new blood test for Alzheimer’s disease

The US FDA has cleared the Elecsys pTau-217 blood test, a diagnostic tool developed by Roche and Eli Lilly to detect Alzheimer's disease pathology. Labcorp will provide the single-biomarker test in specialty and primary care settings for adults 55 and older exhibiting cognitive decline. The test uses a single vial of blood to identify biomarkers, offering a less invasive alternative to traditional diagnostic procedures. Early detection is critical because current FDA-approved prescriptions are most effective when administered during the earliest stages of the disease.

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What changed

Roche Holding has officially secured FDA clearance for the Elecsys pTau-217 blood test.

Live updates

  1. FDA Clears Roche Elecsys pTau-217 Blood Test for Alzheimer's Disease

    The US FDA has cleared the Elecsys pTau-217 blood test, a diagnostic tool developed by Roche and Eli Lilly to detect Alzheimer's disease pathology. Labcorp will provide the single-biomarker test in specialty and primary care settings for adults 55 and older exhibiting cognitive decline. The test uses a single vial of blood to identify biomarkers, offering a less invasive alternative to traditional diagnostic procedures. Early detection is critical because current FDA-approved prescriptions are most effective when administered during the earliest stages of the disease.

    Why it matters

    Traditional Alzheimer's diagnostics often require invasive methods to confirm pathology. This blood-based approach allows clinicians to identify the disease sooner. Earlier diagnosis enables the use of medications that target the disease before significant symptom progression.

    What is confirmed

    • The FDA cleared the Elecsys pTau-217 blood test for Alzheimer's disease.
    • Roche and Eli Lilly developed the single-biomarker diagnostic.
    • Labcorp will offer the test in primary and specialty care settings.
    • The test is intended for adults aged 55 and older showing signs of cognitive decline.
    • The diagnostic identifies biomarkers using a single vial of blood.

    What to watch next

    • Clinical data on the impact of early detection via pTau-217 on patient outcomes
    • Updates on the rollout schedule for Labcorp clinics across the US
    Sources used for this update (7)
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    4. finance.yahoo.com — Roche Holding (SWX:ROP) Secures FDA Clearance For Alzheimer’s Blood Test
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    6. www.wfmz.com — Health Beat: Blood test helps detect Alzheimer's disease early
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  2. Labcorp to deploy FDA-cleared Elecsys pTau-217 Alzheimer's blood test

    Labcorp will offer the Elecsys pTau-217 blood test in primary and specialty care settings following US FDA clearance. Developed by Roche and Eli Lilly, the single-biomarker test detects Alzheimer's disease pathology using a blood sample rather than invasive methods. The diagnostic is intended for adults aged 55 and older who show signs of cognitive decline. By identifying biomarkers in a single vial of blood, the tool helps clinicians detect the disease earlier and provides a less invasive alternative to traditional diagnostic procedures.

    Why it matters

    Early detection of Alzheimer's is critical for managing cognitive decline and accessing potential treatments. Traditional diagnostics often require invasive lumbar punctures or expensive imaging. This blood-based approach simplifies the screening process for healthcare providers.

    What is confirmed

    • The US FDA cleared the Elecsys pTau-217 single-biomarker blood test to detect Alzheimer's disease pathology.
    • Labcorp will provide the Elecsys pTau-217 test in specialty and primary care settings.
    • The test is designed for adults 55 and older experiencing cognitive decline.
    • Roche and Eli Lilly developed the biomarker blood test.

    What to watch next

    • Clinical data on the test's accuracy compared to traditional cerebrospinal fluid analysis
    • Insurance coverage determinations for the Elecsys pTau-217 test
    Sources used for this update (11)
    1. pharmabiz.com — Labcorp to offer Elecsys pTau-217 test, an US FDA-cleared blood test to detect Alzheimer's disease pathology in both primary and specialty care settings
    2. finance.yahoo.com — Eli Lilly Clears Big Hurdle in Alzheimer's Fight
    3. www.inquirer.com — You want to join a clinical trial. Here's what to know about the hurdles.
    4. www.yahoo.com — New Alzheimer's blood test could help doctors detect disease earlier
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    6. medicalxpress.com — Writing the next bible of psychiatry: For the first time, the DSM will use biology to understand mental disorders
    7. elifesciences.org — Prenatal Alcohol Exposure Disrupts γ-Secretase Activity and Impairs Learning and Memory in Wild-Type and 3xTg-AD Mice
    8. www.aol.com — FDA clears first single-biomarker blood test for Alzheimer’s: 4 experts weigh in
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    11. www.detroitnews.com — Want to join a clinical trial? Be prepared for hurdles
    confidence 100%

  3. FDA Approves Roche and Eli Lilly Alzheimer's Blood Test

    The US Food and Drug Administration approved a first-of-its-kind biomarker blood test developed by Roche and Eli Lilly to detect signs of Alzheimer's disease. The test is intended for adults aged 55 and older who are already experiencing cognitive decline. Roche announced the approval on August 24. This diagnostic tool allows clinicians to identify Alzheimer's markers through a blood sample rather than more invasive methods.

    Why it matters

    Early and accurate detection of Alzheimer's is critical for initiating treatment and planning care. Traditional diagnostics often require expensive imaging or invasive spinal taps. This biomarker test provides a less invasive alternative for screening symptomatic older adults.

    What is confirmed

    • The FDA approved an Alzheimer's biomarker blood test developed by Roche and Eli Lilly.
    • The test is designed for people aged 55 and older showing signs of cognitive decline.
    • Roche announced the FDA approval on August 24.

    What to watch next

    • Clinical adoption rates among healthcare providers
    • Insurance coverage determinations for the new test
    • Long-term efficacy data on patient outcomes following blood-test diagnosis
    Sources used for this update (8)
    1. WSJ — FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
    2. Fierce Biotech — Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
    3. Reuters — Roche, Eli Lilly's Alzheimer's blood test gets FDA clearance
    4. The Washington Post — FDA approves a new blood test to detect signs of Alzheimer’s
    5. The Hill — FDA approves new blood test for Alzheimer’s disease
    6. www.aha.org — FDA approves new Alzheimer’s blood test
    7. www.yahoo.com — FDA Approves New Blood Test to Identify Signs of Alzheimer’s
    8. malaysia.news.yahoo.com — Another Alzheimer’s blood test gets OK from FDA
    confidence 100%