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The blood test revolution in Alzheimer's diagnosis

The blood test revolution in Alzheimer's diagnosis

New Capabilities

From $5,000 Brain Scans to $130 Blood Draws

November 14th, 2025: Bipartisan ASAP Act Introduced

Overview

For decades, diagnosing Alzheimer's meant either a $5,000 brain scan with radiation exposure or a painful spinal tap. In October 2025, the FDA cleared Roche's blood test for use in primary care—a simple blood draw that rules out Alzheimer's 97.9% of the time. It's the second blood test approved in five months, transforming a diagnosis that once required specialists and imaging centers into something your family doctor can order.

The stakes are massive: 7.2 million Americans have Alzheimer's, costing $384 billion annually in care. New drugs like Leqembi and Kisunla can slow the disease—but only if patients get diagnosed early, before severe cognitive decline. Blood tests could catch cases years earlier than current methods, finally making the disease detectable when treatment actually works.

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Key Indicators

7.2M
Americans with Alzheimer's
First time prevalence has exceeded 7 million, with projections reaching 13.8 million by 2060
97.9%
Accuracy ruling out disease
Roche's pTau181 test correctly ruled out Alzheimer's in clinical trial of 312 participants
$130
Medicare reimbursement per test
CMS finalized rate after initially proposing just $17, making tests economically viable
$384B
Annual cost of Alzheimer's care
Projected to reach nearly $1 trillion by 2050 without medical breakthroughs
2
FDA-cleared blood tests
Fujirebio's Lumipulse (May 2025) and Roche's Elecsys pTau181 (Oct 2025)

Voices

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People Involved

Jeff Shuren
Jeff Shuren
Oversaw approval of first Alzheimer's blood tests
 Thomas Schinecker
Thomas Schinecker
Led development of newly-approved pTau181 test
 Maria C. Carrillo
Maria C. Carrillo
Advocating for broader access to blood-based diagnostics

Organizations Involved

Roche Diagnostics
Roche Diagnostics
Medical Device Manufacturer
Developer of FDA-cleared Elecsys pTau181 test

Swiss pharmaceutical and diagnostics giant pioneering blood-based Alzheimer's biomarker testing.
Fujirebio Diagnostics
Fujirebio Diagnostics
In Vitro Diagnostics Company
Developer of first FDA-cleared Alzheimer's blood test

Japanese diagnostics company that won FDA clearance for the first Alzheimer's blood test in May 2025.
C2N Diagnostics
C2N Diagnostics
Precision Medicine Company
FDA submission under review for PrecivityAD test

St. Louis-based company pioneering mass spectrometry-based Alzheimer's blood tests.
Eli Lilly and Company
Eli Lilly and Company
Pharmaceutical company
Partner in diagnostic development and maker of Kisunla

Pharmaceutical giant developing both Alzheimer's treatments and the diagnostics to identify eligible patients.
Centers for Medicare & Medicaid Services
Centers for Medicare & Medicaid Services
Federal Agency
Determining reimbursement rates for blood tests

Federal agency whose reimbursement decisions determine whether blood tests become economically viable.
Laboratory Corporation of America
Laboratory Corporation of America
Clinical Laboratory Services
Offering FDA-cleared blood tests nationwide

Major lab operator making Alzheimer's blood tests available at 2,200+ patient service centers.
Quest Diagnostics
Quest Diagnostics
Clinical Laboratory Services
Offering blood tests including direct-to-consumer options

Lab giant offering both physician-ordered and controversial direct-to-consumer Alzheimer's tests.

Timeline

January 2018 November 2025

13 events Latest: November 14th, 2025 · 7 months ago Showing 8 of 13
Tap a bar to jump to that date

  1. Bipartisan ASAP Act Introduced

    Latest Legislative

    Congress introduces bill creating Medicare pathway for FDA-cleared blood biomarker screening tests.

  2. FDA Clears Roche Test for Primary Care

    Regulatory

    Elecsys pTau181 becomes first blood test cleared specifically for primary care use, ruling out disease 97.9% of the time.

  3. C2N Submits FDA Application

    Regulatory

    C2N files first multi-analyte algorithmic blood test using high-resolution mass spectrometry for FDA review.

  4. Labcorp Launches Lumipulse Nationwide

    Commercial

    First FDA-cleared test becomes available at 2,200+ Labcorp patient service centers across United States.

  5. Roche Receives European CE Mark

    Regulatory

    Elecsys pTau181 test receives CE Mark certification, clearing path for European market entry.

  6. FDA Clears First Alzheimer's Blood Test

    Regulatory

    Fujirebio's Lumipulse becomes first FDA-cleared blood test, measuring pTau217/Aβ1-42 ratio with 91.7% positive predictive value.

  7. Fujirebio Discovers Manufacturing Issues

    Quality

    At CTAD conference, Fujirebio identifies problems with commercial lots, placing Lumipulse product on quality hold.

  8. CMS Finalizes $130 Reimbursement Rate

    Policy

    After proposing just $17, CMS sets $130 Medicare reimbursement, making tests economically viable for labs.

  9. FDA Approves Kisunla, Second Anti-Amyloid Drug

    Treatment

    Donanemab approval intensifies pressure for accessible diagnostics, as drug only works in early-stage disease.

  10. Roche-Lilly Test Gets Breakthrough Designation

    Regulatory

    FDA grants Roche's Elecsys pTau217 test Breakthrough Device designation, expediting review for partnership with Eli Lilly.

  11. Quest Launches Controversial Direct-to-Consumer Test

    Commercial

    Quest introduces direct-to-consumer Alzheimer's blood test, sparking debate about testing without physician guidance.

  12. FDA Approves Leqembi, First Disease-Modifying Drug

    Treatment

    Lecanemab becomes first therapy proven to slow Alzheimer's cognitive decline, creating urgent need for early diagnostic tools.

  13. C2N Receives First Breakthrough Device Designation

    Regulatory

    FDA grants C2N Diagnostics Breakthrough Device designation for its mass spectrometry-based blood test, beginning the regulatory sprint.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1985-1990

HIV Antibody Test Approval (1985)

FDA approved the first blood test detecting HIV antibodies in March 1985, three years after HIV was identified as the cause of AIDS. The test transformed a death sentence into a manageable chronic disease by enabling early treatment. However, initial rollout faced controversy over false positives, stigma, and questions about testing without available treatments.

Then

Testing initially limited to blood banks and high-risk populations, with significant debate over mandatory testing.

Now

Blood testing became routine medical practice, enabling the antiviral revolution that turned HIV into a manageable condition.

Why this matters now

Like HIV testing, Alzheimer's blood tests arrive alongside new treatments (Leqembi, Kisunla) that work best when disease is caught early—but raise similar questions about testing people when treatments aren't universally accessible.

1994-2012

PSA Test for Prostate Cancer (1994)

FDA approved PSA blood testing for prostate cancer screening in 1994, promising early detection through simple blood draws instead of biopsies. Adoption soared. By 2008, most men over 50 were getting regular PSA tests. However, studies revealed widespread overdiagnosis and overtreatment—many men received aggressive treatment for slow-growing cancers that would never have harmed them.

Then

PSA testing became standard of care, with millions of men screened annually and prostate cancer detection increasing sharply.

Now

In 2012, the US Preventive Services Task Force recommended against routine PSA screening after data showed harms outweighed benefits for most men.

Why this matters now

Cautionary tale for Alzheimer's blood tests: early detection isn't always beneficial if treatments are limited, expensive, or carry significant side effects—and if tests generate false positives causing unnecessary anxiety.

2015-2018

Theranos Blood Testing Scandal (2015-2018)

Theranos claimed revolutionary blood testing technology using fingerprick samples, attracting $700 million in investment and partnerships with Walgreens. Investigative journalism revealed the technology didn't work—tests were inaccurate and the company used traditional machines for most analyses. Founder Elizabeth Holmes was convicted of fraud. The scandal traumatized the blood testing industry.

Then

Theranos collapsed, investors lost hundreds of millions, and regulatory scrutiny of diagnostic startups intensified dramatically.

Now

FDA tightened oversight of laboratory-developed tests; investors became cautious about diagnostic companies; public trust in blood testing innovation damaged.

Why this matters now

The Theranos shadow looms over Alzheimer's blood tests—explaining why FDA demanded rigorous validation, why some experts questioned Quest's direct-to-consumer model, and why Fujirebio's manufacturing issues triggered immediate concern.

Sources

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FDA Roche Diagnostics Alzheimer's Association CNN Nature Alzheimer's & Dementia Labcorp Quest Diagnostics Quest Diagnostics C2N Diagnostics ALZFORUM UsAgainstAlzheimer's FierceBiotech Alzheimer's Association FDA Roche Diagnostics Alzheimer's Association Quest Diagnostics