Abbott launches SimpleScreen CRC blood test for colorectal cancer screening

Overview

Updated 48 minutes ago

Abbott began selling SimpleScreen CRC on September 30, giving average-risk Americans 45 and older a second FDA-approved blood test for colorectal cancer screening. The test reads cell-free DNA from a simple blood draw for signals associated with cancer. Abbott is betting it reaches people who never complete a colonoscopy or stool test.

The performance data shows both the promise and the limit. SimpleScreen detects about 8 in 10 colorectal cancers in a large clinical study, but only about 14% of advanced precancerous lesions. The American Cancer Society calls blood tests "not preferred" because stool tests and colonoscopy catch far more precancerous growths, yet a blood test still beats skipping screening entirely.

Why it matters

A blood test more people will complete could catch colorectal cancer earlier, but it misses most precancerous lesions colonoscopy finds.

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Key Indicators

81.1%

Colorectal cancer detection sensitivity

Age-sex adjusted from the PREEMPT CRC study; correctly identified about 8 in 10 cancers.

13.7%

Advanced precancerous lesion detection

The test misses about 86% of advanced precancerous lesions, per FDA-approved labeling.

90.4%

Specificity for advanced colorectal neoplasia

Nine in 10 people without colorectal cancer or advanced lesions received correct negative results.

48,000+

PREEMPT CRC study participants

Largest prospective validation study ever conducted for a blood-based colorectal cancer screening test.

$100M

Abbott milestone payment to Freenome

Paid upon FDA approval under the August 2025 exclusive U.S. commercialization agreement.

Voices

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Organizations Involved

Abbott

Publicly traded medical devices and diagnostics company

Exclusive U.S. commercializer of SimpleScreen CRC; operator of Cologuard franchise

Abbott is a global health care company whose diagnostics division now commercializes both the Cologuard Plus stool test and the SimpleScreen CRC blood test.

Freenome

Publicly traded biotechnology company (Nasdaq: FRNM)

Developer and manufacturer of SimpleScreen CRC; receives milestone payments tied to commercial performance

Freenome developed SimpleScreen CRC, a blood test that reads circulating cell-free DNA for colorectal cancer signals.

American Cancer Society

Nonprofit cancer advocacy and guideline organization

Sets screening guidelines that shape which tests doctors recommend

The American Cancer Society publishes colorectal cancer screening guidelines that clinicians follow when recommending tests to patients.

U.S. Food and Drug Administration

Federal regulatory agency

Granted premarket approval for SimpleScreen CRC on July 24, 2026

The FDA approved SimpleScreen CRC through its premarket approval (PMA) pathway, the agency's most stringent review for medical devices.

Timeline

August 2025 September 2026

4 events Latest: Today

Tap a bar to jump to that date

September 2026
Abbott launches SimpleScreen CRC commercially
Today Launch

SimpleScreen CRC becomes available in the U.S. for average-risk adults 45+, joining Cologuard Plus in Abbott's colorectal cancer screening portfolio.
Today
July 2026
Freenome and Abbott announce FDA approval
Announcement

Freenome receives the $100 million milestone payment from Abbott. Both companies say the test will launch commercially in the fall.
July 27th, 2026
FDA approves SimpleScreen CRC
Regulatory

FDA grants premarket approval (PMA) for SimpleScreen CRC as a blood-based colorectal cancer screening test for average-risk adults 45 and older.
July 24th, 2026
August 2025
Freenome and Abbott sign exclusive U.S. commercialization agreement
Agreement

Freenome agrees to let Abbott exclusively commercialize SimpleScreen CRC in the U.S., with milestone payments tied to FDA approval.
August 1st, 2025

Scenarios

SimpleScreen CRC tops 500,000 tests as unscreened adults adopt blood screening

Possible Resolves by Q2 2027

Discussed by: Abbott and Freenome's stated expansion goal; analysts tracking Medicare claims and quarterly reports

Abbott's patient navigation program, Medicare coverage, and flexible blood draws (mobile phlebotomy or participating labs) drive adoption among the estimated one-third of eligible adults who never completed screening. If clinician ordering ramps through Abbott's existing primary care network built for Cologuard, SimpleScreen could establish blood-based screening as a mainstream option within a year of launch.

ACS keeps blood tests 'not preferred,' capping SimpleScreen adoption

Likely Resolves by End of 2027

Discussed by: American Cancer Society guideline authors; gastroenterology professional societies

Current ACS guidance says blood tests should only be used when patients decline stool tests or colonoscopy. If the society's next guideline update retains this language, physicians may continue steering patients toward Cologuard Plus and colonoscopy, relegating SimpleScreen to second-line status. Freenome expects the test to be named in guidelines, but naming a test while labeling it "not preferred" still constrains uptake.

SimpleScreen and Shield compete on price, driving down screening costs

Possible Resolves by End of 2027

Discussed by: Market analysts covering the cancer diagnostics sector

With two FDA-approved blood tests targeting the same average-risk population, competition could push list prices down and prompt insurers and the Centers for Medicare & Medicaid Services (CMS) to adjust reimbursement. Both Abbott and Guardant Health have patient-support infrastructure and Medicare coverage. A pricing response would expand access but compress margins for both companies.

Historical Context

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

August 2014

Cologuard launch (2014)

Exact Sciences won FDA approval for Cologuard, a stool-based DNA test for colorectal cancer screening in adults 50 and older. It was the first widely available non-invasive home screening option that rivaled colonoscopy's convenience and came bundled with Medicare coverage and a patient-support program.

Then

Cologuard became the dominant non-invasive screening product, with Exact Sciences processing over a million tests annually within a few years of launch.

Now

It demonstrated that at-home screening with robust patient navigation could reach people who avoided colonoscopy, setting a model Abbott now extends to blood testing.

Why this matters now

SimpleScreen CRC is Abbott's attempt to apply the Cologuard playbook to blood testing, which requires even less patient effort than mailing a stool sample.

July 2024

Guardant Health Shield approval (2024)

The FDA approved Shield, Guardant Health's blood-based colorectal cancer screening test, for average-risk adults 45 and older. Shield showed about 83% sensitivity for colorectal cancer but only about 13% for advanced adenomas in the ECLIPSE study of nearly 18,000 participants.

Then

Shield entered the U.S. market with Medicare coverage, establishing blood-based colorectal cancer screening as a commercially viable category.

Now

The approval opened the regulatory path SimpleScreen CRC follows and set expectations that blood tests detect cancer well but precancerous lesions poorly.

Why this matters now

SimpleScreen is the second FDA-approved blood-based colorectal cancer test and competes directly with Shield for the same population of unscreened adults.