The blood test revolution in Alzheimer's diagnosis

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.

In This Story

3 People

7 Orgs

Blood Tests Become Standard of Care in Primary Medicine

3 Context

HIV Antibody Test Approval (1985)

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

FDA-cleared blood tests

Fujirebio's Lumipulse (May 2025) and Roche's Elecsys pTau181 (Oct 2025)

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Debate Arena

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People Involved

Jeff Shuren

Director, FDA Center for Devices and Radiological Health (Oversaw approval of first Alzheimer's blood tests)

Thomas Schinecker

CEO, Roche (Led development of newly-approved pTau181 test)

Maria C. Carrillo

Chief Science Officer, Alzheimer's Association (Advocating for broader access to blood-based diagnostics)

Organizations Involved

Roche Diagnostics

Medical Device Manufacturer

Status: Developer of FDA-cleared Elecsys pTau181 test

Swiss pharmaceutical and diagnostics giant pioneering blood-based Alzheimer's biomarker testing.

Fujirebio Diagnostics

In Vitro Diagnostics Company

Status: 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

Precision Medicine Company

Status: FDA submission under review for PrecivityAD test

St. Louis-based company pioneering mass spectrometry-based Alzheimer's blood tests.

Eli Lilly and Company

Pharmaceutical Company

Status: 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

Federal Agency

Status: Determining reimbursement rates for blood tests

Federal agency whose reimbursement decisions determine whether blood tests become economically viable.

Laboratory Corporation of America

Clinical Laboratory Services

Status: Offering FDA-cleared blood tests nationwide

Major lab operator making Alzheimer's blood tests available at 2,200+ patient service centers.

Quest Diagnostics

Clinical Laboratory Services

Status: Offering blood tests including direct-to-consumer options

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

Timeline

Bipartisan ASAP Act Introduced
Legislative

Congress introduces bill creating Medicare pathway for FDA-cleared blood biomarker screening tests.
November 14th, 2025
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.
October 13th, 2025
C2N Submits FDA Application
Regulatory

C2N files first multi-analyte algorithmic blood test using high-resolution mass spectrometry for FDA review.
October 1st, 2025
Labcorp Launches Lumipulse Nationwide
Commercial

First FDA-cleared test becomes available at 2,200+ Labcorp patient service centers across United States.
August 1st, 2025
Roche Receives European CE Mark
Regulatory

Elecsys pTau181 test receives CE Mark certification, clearing path for European market entry.
July 23rd, 2025
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.
May 16th, 2025
Fujirebio Discovers Manufacturing Issues
Quality

At CTAD conference, Fujirebio identifies problems with commercial lots, placing Lumipulse product on quality hold.
November 15th, 2024
CMS Finalizes $130 Reimbursement Rate
Policy

After proposing just $17, CMS sets $130 Medicare reimbursement, making tests economically viable for labs.
November 1st, 2024
FDA Approves Kisunla, Second Anti-Amyloid Drug
Treatment

Donanemab approval intensifies pressure for accessible diagnostics, as drug only works in early-stage disease.
July 2nd, 2024
Roche-Lilly Test Gets Breakthrough Designation
Regulatory

FDA grants Roche's Elecsys pTau217 test Breakthrough Device designation, expediting review for partnership with Eli Lilly.
April 11th, 2024
Quest Launches Controversial Direct-to-Consumer Test
Commercial

Quest introduces direct-to-consumer Alzheimer's blood test, sparking debate about testing without physician guidance.
July 31st, 2023
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.
July 6th, 2023
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.
January 1st, 2018

Scenarios

Blood Tests Become Standard of Care in Primary Medicine

Discussed by: Alzheimer's Association, Mayo Clinic researchers, diagnostic industry analysts

With Medicare covering tests at $130 and major labs offering nationwide availability, primary care physicians routinely order blood tests during annual wellness visits for patients over 65. Early detection increases dramatically, catching disease 3-5 years before traditional diagnosis. New drug treatments work better when started early. Deaths from Alzheimer's begin declining for the first time in decades. Additional biomarkers get approved, creating diagnostic panels. The $5,000 brain scan becomes reserved only for ambiguous cases.

Quality and Accuracy Issues Undermine Confidence

Discussed by: ALZFORUM, medical journal editorials, consumer advocacy groups

Manufacturing problems like Fujirebio's quality hold prove systemic across blood test makers. False positives create anxiety and unnecessary follow-up testing. Variations between labs produce inconsistent results. Primary care doctors, lacking dementia expertise, misinterpret findings. High-profile misdiagnosis cases emerge. Medicare restricts coverage pending additional validation. Adoption stalls as specialists question whether tests are ready for widespread use outside research settings.

Direct-to-Consumer Testing Creates Diagnostic Chaos

Discussed by: Bioethics experts, ALZFORUM commentators, neurologist associations

Quest's direct-to-consumer model expands as competitors follow. Millions of worried middle-aged people order tests without medical supervision. Many receive positive results but lack access to new treatments due to insurance barriers or geographic constraints. Anxiety and depression spike among those testing positive who can't afford $26,500 annual drug costs. Memory clinics overwhelmed with patients seeking confirmatory testing. Regulatory crackdown on direct marketing of tests without physician involvement.

New Biomarkers Outpace Current Generation

Discussed by: Nature Medicine researchers, pharmaceutical companies developing diagnostics

Research identifies superior biomarkers beyond pTau217 and pTau181, such as neurofilament light chain or novel inflammatory markers. Next-generation tests combine multiple biomarkers into algorithmic scores with 99%+ accuracy. Companies like C2N gain market advantage with mass spectrometry platforms. First-generation tests from Roche and Fujirebio become obsolete within 3-4 years. Labs face costly equipment upgrades. Early adopters regret infrastructure investments in soon-outdated technology.

Historical Context

HIV Antibody Test Approval (1985)

1985-1990

What Happened

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.

Outcome

Short Term

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

Long Term

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

Why It's Relevant Today

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.

PSA Test for Prostate Cancer (1994)

1994-2012

What Happened

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.

Outcome

Short Term

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

Long Term

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

Why It's Relevant Today

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.

Theranos Blood Testing Scandal (2015-2018)

2015-2018

What Happened

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.

Outcome

Short Term

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

Long Term

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

Why It's Relevant Today

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.