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FDA Clears Roche And Eli Lilly’s Alzheimer’s Blood Test

The FDA cleared blood tests from Roche and C2N Diagnostics to identify amyloid pathology in patients. These tools allow clinicians to detect brain plaques associated with Alzheimer's disease before a standard diagnosis would typically occur. The PrecivityAD2 test is approved for adults as young as 40. These diagnostics provide a less invasive alternative to previous methods for ruling in or ruling out the pathology of cognitive decline.

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  • ✓ The FDA cleared blood tests from Roche and C2N Diagnostics for Alzheimer's disease.
  • ✓ PrecivityAD2 is approved for use in adults as young as 40.
🛡️ Source Corroboration: 41 independent reporting domains (100% confidence) ⏱ Read time: ~2 min

What changed

Recent reports confirm the tests can identify brain plaques long before a typical diagnosis is made.

Live updates

  1. FDA Clears Alzheimer's Blood Tests from Roche and C2N Diagnostics

    The FDA cleared blood tests from Roche and C2N Diagnostics to identify amyloid pathology in patients. These tools allow clinicians to detect brain plaques associated with Alzheimer's disease before a standard diagnosis would typically occur. The PrecivityAD2 test is approved for adults as young as 40. These diagnostics provide a less invasive alternative to previous methods for ruling in or ruling out the pathology of cognitive decline.

    Why it matters

    Early detection of amyloid plaques allows for earlier intervention in Alzheimer's treatment. These blood-based tests replace more invasive diagnostic procedures. This expansion of diagnostic options aims to identify brain changes in younger adult populations.

    What is confirmed

    • The FDA cleared blood tests from Roche and C2N Diagnostics for Alzheimer's disease.
    • PrecivityAD2 is approved for use in adults as young as 40.

    What to watch next

    • Clinical adoption rates of the Elecsys pTau217 test
    • FDA decisions on further diagnostic tools for cognitive decline
    Sources used for this update (3)
    1. www.biopharmadive.com — Optogenetics researchers win a Nobel Prize; Roche bets on Alector brain drug | BioPharma Dive
    2. www.archyde.com — FDA Clears Two New Alzheimer’s Blood Tests from Roche, C2N ...
    3. welltica.com — A blood test can now detect early Alzheimer’s changes in ...
    confidence 100%

  2. FDA Clears Blood-Based Alzheimer's Diagnostic Tests

    The US FDA cleared four blood-based Alzheimer's tests to help clinicians identify amyloid pathology in patients. These include the Elecsys pTau217 test developed by Roche and Eli Lilly, as well as C2N Diagnostics' PrecivityAD2. These tools provide a less invasive method for physicians to evaluate cognitive decline and predict brain changes associated with the disease. PrecivityAD2 is approved for use in adults as young as 40. The clearance allows for more accessible rule-in and rule-out procedures for Alzheimer's pathology compared to previous diagnostic methods.

    Why it matters

    Traditional Alzheimer's diagnosis often requires invasive procedures or expensive imaging to detect amyloid plaques. Blood tests reduce patient burden and may speed up the identification of eligible candidates for treatment. The FDA manages these clearances through the Center for Drug Evaluation and Research to ensure medical device safety and efficacy.

    What is confirmed

    • The FDA cleared four blood-based Alzheimer's tests, including Roche's Elecsys pTau217 developed with Eli Lilly and C2N Diagnostics' PrecivityAD2.
    • PrecivityAD2 is indicated for adults as young as 40.
    • The FDA is a federal agency of the US Department of Health and Human Services responsible for the safety and efficacy of medical devices and drugs.
    • The Center for Drug Evaluation and Research ensures safe and effective drugs are available in the United States.

    What to watch next

    • Clinical adoption rates of blood-based tests versus traditional PET scans
    • FDA updates on additional amyloid pathology biomarkers
    • Long-term efficacy data for patients diagnosed via blood tests
    Sources used for this update (9)
    1. www.fda.gov — U.S. Food and Drug Administration
    2. www.fda.gov — Drugs | FDA
    3. en.wikipedia.org — Food and Drug Administration - Wikipedia
    4. www.usa.gov — Food and Drug Administration (FDA) | USAGov
    5. www.biopharmadive.com — Lilly, Foghorn part ways; Wave’s FDA-approved plans | BioPharma Dive
    6. www.archyde.com — Tirzepatide therapy initial weight reduction variations explained – Archyde
    7. datadashboard.fda.gov — FDA Dashboards - Home
    8. direct.fda.gov — FDA Direct - Food and Drug Administration
    9. www.youtube.com — U.S. Food and Drug Administration - YouTube
    confidence 100%

  3. FDA Clears Four Alzheimer's Blood Tests

    The US FDA has cleared four blood-based Alzheimer's tests, including Roche's Elecsys pTau217 developed with Eli Lilly, and C2N Diagnostics' PrecivityAD2. These tests help clinicians rule in and rule out amyloid pathology in Alzheimer's disease patients. The clearance provides physicians with less invasive diagnostic tools to evaluate cognitive decline and predict brain changes associated with Alzheimer's. PrecivityAD2 is indicated for adults as young as 40.

    Why it matters

    The FDA's clearance of these blood tests marks a significant development in Alzheimer's diagnosis, offering a less invasive alternative to existing methods. Alzheimer's disease is a complex condition, and early diagnosis is crucial for effective management. The availability of these tests is expected to impact primary care and the way clinicians approach cognitive decline.

    What is confirmed

    • The FDA has cleared four blood-based Alzheimer's tests.
    • Roche's Elecsys pTau217 is one of the cleared tests.
    • C2N Diagnostics' PrecivityAD2 is indicated for adults as young as 40.
    • These tests help clinicians rule in and rule out amyloid pathology in Alzheimer's disease patients.

    What to watch next

    • How primary care clinicians will interpret and act on results from these tests
    • Potential impact on Alzheimer's diagnosis and treatment
    • Future FDA clearances for similar tests
    Sources used for this update (4)
    1. emerging-tech-lab.com — FDA Clears Four Alzheimer's Blood Tests as Simpler Diagnosis ...
    2. us.headtopics.com — FDA Clears Roche Elecsys pTau217 and C2N PrecivityAD2 ...
    3. www.biopharmadive.com — PhRMA names next CEO; Pierre Fabre takes third swing at Ebvallo approval | BioPharma Dive
    4. southfloridareporter.com — FDA Clears 2 New Alzheimer’s Blood Tests, Including One For ...
    confidence 100%

  4. FDA Clears Roche and Eli Lilly's Alzheimer's Blood Test

    The US FDA has cleared Roche's Elecsys pTau217 blood test, developed in collaboration with Eli Lilly, to help clinicians rule in and rule out amyloid pathology in Alzheimer's disease patients. This test is the first single-biomarker blood test for this purpose. The clearance provides physicians with a less invasive diagnostic tool to evaluate cognitive decline and predict brain changes associated with Alzheimer's.

    Why it matters

    Alzheimer's disease is a neurodegenerative disorder that affects millions of people worldwide. Early diagnosis and detection are crucial for effective management and treatment. The FDA's clearance of this blood test offers a new option for clinicians to assess patients with suspected Alzheimer's.

    What is confirmed

    • The FDA cleared Roche's Elecsys pTau217 blood test for Alzheimer's disease.
    • The Elecsys pTau217 blood test was developed by Roche in collaboration with Eli Lilly.
    • The test helps clinicians rule in and rule out amyloid pathology in patients with Alzheimer's disease.
    • The FDA also cleared C2N Diagnostics' PrecivityAD2 blood test for Alzheimer's disease.

    What to watch next

    • Future studies on the effectiveness of these blood tests in clinical practice
    • Potential approval of other Alzheimer's disease diagnostic tests
    • Updates on Roche and Eli Lilly's ongoing research and development of Alzheimer's treatments
    Sources used for this update (12)
    1. www.foxbusiness.com — Health Care
    2. www.daijiworld.com — FDA clears two new blood tests for Alzheimer’s assessment
    3. www.medicalnewstoday.com — New FDA-cleared blood tests could help identify Alzheimer’s earlier - MedicalNewsToday
    4. www.neurologylive.com — From Biomarkers to Prevention: Key Alzheimer Research Stories of 2026 | NeurologyLive - Clinical Neurolog....
    5. www.ajmc.com — Value-Based Care | Topic | AJMC
    6. pharmaphorum.com — FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test
    7. trial.medpath.com — FDA Grants Clearance to Two New Blood Tests for Alzheimer's ...
    8. www.headlinesorbit.com — FDA Clears Roche Elecsys pTau217 and C2N PrecivityAD2 ...
    9. www.biopharmadive.com — Novo pursues long-acting obesity drugs; Acadia slumps on Alzheimer’s data | BioPharma Dive
    10. pharmaphorum.com — Roche, Lilly join forces on blood test for Alzheimer’s
    11. www.biopharmadive.com — Lilly’s latest China drug deal; Immunovant’s setback in lupus | BioPharma Dive
    12. clearthoughtsfoundation.org — Detecting Alzheimer’s Through Blood Tests: What You Need to ...
    confidence 100%

  5. FDA Clears Roche and Eli Lilly Alzheimer Blood Test

    The US Food and Drug Administration cleared the Elecsys pTau217 blood test, developed by Roche in collaboration with Eli Lilly. This assay serves as the first single-biomarker blood test to help clinicians rule in and rule out amyloid pathology in patients with Alzheimer's disease. The clearance provides physicians with a less invasive diagnostic tool to evaluate cognitive decline and predict brain changes associated with the condition.

    Why it matters

    Traditional Alzheimer's assessment methods often involve invasive or costly procedures to detect amyloid pathology. Blood-based biomarkers aim to streamline early evaluation for adults experiencing cognitive symptoms. Meanwhile, related clinical developments continue in Europe, where a major trial for Roche's Brainshuttle drug trontinemab recently started in the UK.

    What is confirmed

    • The US Food and Drug Administration cleared the Elecsys pTau217 blood test developed by Roche in collaboration with Eli Lilly.
    • The Elecsys pTau217 test acts as the first single-biomarker assay to help rule in and rule out amyloid pathology in Alzheimer's disease.
    • Roche announced a separate collaboration with Treeline Biosciences to study combination immunotherapies for B-cell lymphomas.
    • The PrevenTRON trial for Roche's Brainshuttle drug trontinemab in preclinical Alzheimer's disease has started in the UK.

    Still unconfirmed

    • Labcorp and Quest Diagnostics plan to provide the Elecsys pTau217 test to healthcare providers.

    What to watch next

    • Implementation of the Elecsys pTau217 blood test by diagnostic providers such as Labcorp and Quest Diagnostics
    • Results from the PrevenTRON trial of Roche's trontinemab drug in the UK
    • Further clinical updates from Roche and Treeline Biosciences regarding B-cell lymphoma therapies
    Sources used for this update (3)
    1. finance.yahoo.com — Roche Holding (SWX:ROP) Received FDA Clearance For An Alzheimer’s Blood Test
    2. pharmaphorum.com — Major trial of Roche Alzheimer's drug kicks off in Europe
    3. medicaldialogues.in — US FDA clears Roche's Elecsys® pTau217 blood test, developed in collaboration with Lilly, to aid identification of amyloid pathology associated with Alzheimer's disease
    confidence 90%

  6. FDA Clears Roche and Eli Lilly Alzheimer's Blood Test

    The US FDA cleared the Elecsys pTau217 blood test, a collaboration between Roche and Eli Lilly, to help physicians identify signs of Alzheimer's disease. The test targets adults aged 55 and older who show symptoms of cognitive decline. As the first single-biomarker blood test of its kind, it predicts the likelihood of Alzheimer's-related brain changes. Labcorp and Quest Diagnostics plan to provide the test to healthcare providers, offering a less invasive alternative to traditional assessment methods.

    Why it matters

    Traditional Alzheimer's assessments often rely on expensive or invasive procedures that are difficult for many patients to access. This blood-based approach aims to simplify how doctors evaluate patients for brain changes. The test focuses on a specific biomarker to streamline the screening process.

    What is confirmed

    • The FDA cleared the Elecsys pTau217 blood test for adults 55 and older with signs of cognitive decline.
    • Roche and Eli Lilly collaborated to develop the test.
    • The tool is a single-biomarker blood test used to identify signs of Alzheimer's disease.

    What to watch next

    • Integration of amyloid blood tests into routine primary care health checks
    • Clinical adoption rates by healthcare providers via Labcorp and Quest Diagnostics
    Sources used for this update (4)
    1. finance.yahoo.com — Roche Holding (SWX:ROP) Secures FDA Clearance For Alzheimer’s Blood Test
    2. www.medicalbrief.co.za — First single-biomarker blood test for Alzheimer's approved
    3. www.psychologytoday.com — Can a Blood Test Predict Your Risk of Alzheimer’s Disease?
    4. finance.yahoo.com — Could Roche and Lilly’s Blood Test Make Alzheimer’s Assessment More Accessible?
    confidence 100%

  7. FDA clears first single-biomarker blood test for Alzheimer's

    The US FDA cleared the Elecsys pTau217 blood test, developed by Roche and Eli Lilly, to identify signs of Alzheimer's disease in adults 55 and older experiencing cognitive decline. This tool uses a single biomarker to predict the likelihood of Alzheimer's-related changes rather than providing a formal diagnosis. Labcorp and Quest Diagnostics intend to offer the test to healthcare providers.

    Why it matters

    Traditional Alzheimer's detection often requires more invasive or expensive procedures. This blood test provides a less intrusive method for doctors to screen patients. It marks a shift toward biomarker-based screening for cognitive impairment.

    What is confirmed

    • The FDA cleared the Elecsys pTau217 blood test developed by Roche and Eli Lilly.
    • The test is intended for adults aged 55 and older with cognitive decline.
    • The pTau217 test uses a single biomarker to predict Alzheimer's-related changes.
    • The test does not provide a formal diagnosis of Alzheimer's disease.

    What to watch next

    • Implementation timelines for Labcorp and Quest Diagnostics
    • Clinical outcomes from widespread adoption of the pTau217 test
    Sources used for this update (4)
    1. finance.yahoo.com — Eli Lilly Clears Big Hurdle in Alzheimer's Fight
    2. finance.yahoo.com — FDA Nods Lilly-Roche's Alzheimer's Blood Test: Healthcare ETFs to Track Now
    3. sg.news.yahoo.com — Russia’s overnight drone barrage ignites fires across Ukrainian cities
    4. www.aol.com — FDA clears first single-biomarker blood test for Alzheimer’s: 4 experts weigh in
    confidence 100%

  8. FDA Clears Roche and Eli Lilly's Alzheimer's Blood Test

    The US FDA has cleared the Elecsys pTau217 blood test developed by Roche and Eli Lilly to help detect signs of Alzheimer's disease in adults aged 55 and older with cognitive decline. The test predicts the likelihood of Alzheimer's-related changes using a single biomarker but does not provide a formal diagnosis. Labcorp and Quest Diagnostics plan to offer the test.

    Why it matters

    This clearance is significant for Alzheimer's diagnosis, as it provides a simpler way to assess Alzheimer's-related changes. The test is designed to aid the evaluation process for patients reporting cognitive issues. Alzheimer's disease is a complex condition, and early detection is crucial for effective management.

    What is confirmed

    • The Elecsys pTau217 blood test is intended for adults aged 55 and older who are experiencing cognitive decline.
    • The test predicts the likelihood of Alzheimer's-related changes using a single biomarker.
    • Labcorp and Quest Diagnostics both plan to offer the test.
    • The test secured CE mark certification earlier this year.
    • The FDA clearance was announced on August 24 by Roche.

    What to watch next

    • Health Canada status and Canadian availability of the test
    • Disclosed price of the test
    • Future FDA clearances for similar Alzheimer's blood tests
    Sources used for this update (7)
    1. www.yahoo.com — Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test
    2. www.aha.org — FDA approves new Alzheimer’s blood test
    3. insights.citeline.com — US Alzheimer’s Blood Test Battle Begins With Roche, C2N FDA Clearence
    4. www.benefitsandpensionsmonitor.com — FDA clears blood test to flag Alzheimer's in patients 55 and older
    5. uk.finance.yahoo.com — Eli Lilly Clears Big Hurdle in Alzheimer's Fight
    6. ca.style.yahoo.com — FDA clears two more Alzheimer's blood tests in a single week
    7. www.yahoo.com — FDA Approves Pancreatic Cancer Drug That Could Double Survival Time
    confidence 100%

  9. FDA Clears Roche and Eli Lilly Alzheimer's Blood Test

    The US Food and Drug Administration cleared the Elecsys pTau217 blood test developed by Roche and Eli Lilly to help detect signs of Alzheimer's disease. The test is intended for adults age 55 and older who are experiencing cognitive decline. While the test predicts the likelihood of Alzheimer's-related changes using a single biomarker, it does not provide a formal diagnosis of the brain disorder. The tool is designed to aid the evaluation process for patients reporting cognitive issues.

    Why it matters

    Traditional Alzheimer's detection often requires more invasive or expensive procedures. Moving biomarker testing into primary care could streamline the early identification of the disease. This shift allows clinicians to screen patients more efficiently before pursuing definitive diagnostic paths.

    What is confirmed

    • The FDA cleared a blood test developed by Roche and Eli Lilly to help identify signs of Alzheimer's disease.
    • The test is intended for use in adults age 55 and older with cognitive decline.
    • The specific test name is Elecsys pTau217.
    • The test uses a single biomarker to predict the likelihood of Alzheimer's-related changes.
    • The blood test is not a diagnosis of Alzheimer's disease.

    What to watch next

    • Integration of the test into primary care clinical workflows
    • Clinical data on the test's accuracy compared to traditional diagnostic methods
    Sources used for this update (11)
    1. WSJ — FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
    2. Forbes — FDA Clears Roche And Eli Lilly’s Alzheimer’s Blood Test
    3. WashU Medicine — FDA clears blood test to aid evaluation for Alzheimer’s disease
    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. consent.yahoo.com — FDA clears Roche and Eli Lilly Alzheimer's blood test
    7. theprint.in — US FDA clears Roche-Lilly single-biomarker blood test that helps check for Alzheimer’s-linked changes
    8. www.yahoo.com — Roche, Eli Lilly’s Alzheimer’s blood test gets FDA clearance
    9. www.straitstimes.com — Roche, Eli Lilly’s Alzheimer’s blood test gets US FDA clearance
    10. pharmaphorum.com — FDA greenlights Roche’s biomarker blood test for Alzheimer's
    11. finance.yahoo.com — Roche, Lilly Get US FDA Clearance for Alzheimer's Blood Test
    confidence 100%
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