FDA Approves SimpleScreen CRC Blood Test for Colorectal Cancer Screening

The US Food and Drug Administration (FDA) has approved SimpleScreen CRC, a blood-based screening test for colorectal cancer (CRC) in adults aged 45 years and older at average risk for the disease. Developed by Freenome and exclusively commercialized in the United States by Abbott beginning this fall, SimpleScreen CRC’s approval is based on results from PREEMPT CRC, a prospective validation study enrolling more than 48,000 adults scheduled for screening colonoscopy.¹

As described in the July 27, 2026, press release, SimpleScreen CRC adds a blood-based option alongside Abbott's existing stool DNA test Cologuard, expanding the noninvasive screening landscape for patients who decline or delay colonoscopy.¹ With FDA approval, the test now meets Medicare coverage criteria and is expected to be incorporated by name into American Cancer Society screening guidelines.¹

“The most effective screening test is the one a person will actually complete,” Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC® study, said in a statement. “Many people who should be screened for colorectal cancer simply aren’t. A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes.”

SimpleScreen CRC Design and Results in PREEMPT CRC

PREEMPT CRC is described by Freenome and Abbott as the largest prospective clinical validation study conducted for a blood-based CRC screening test.¹ The trial enrolled more than 48,000 asymptomatic, average-risk adults aged 45 to 85 years across more than 200 sites, all scheduled for a screening colonoscopy.¹ SimpleScreen CRC detects signals associated with CRC from cell-free DNA (cfDNA) using an AI/ML-driven detection approach.¹

In a prespecified analysis adjusted to match the US Census, SimpleScreen CRC detected CRC with 81.1% sensitivity.¹ The test detected advanced precancerous lesions (APLs) with 13.7% sensitivity overall, including 30.7% sensitivity for APLs with high-grade dysplasia.¹ Specificity for advanced colorectal neoplasia was 90.4%, corresponding to a negative result in approximately 9 of 10 people without CRC or APLs.¹

SimpleScreen CRC Commercialization and Clinical Context

A positive SimpleScreen CRC result indicates detection of a signal suggesting possible CRC or an APL, and Freenome and Abbott state a positive result should be followed by diagnostic colonoscopy.¹ The companies specify SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in individuals at high risk for CRC.¹

Under a commercial agreement signed in August 2025, Abbott will pay Freenome a $100 million milestone payment tied to this approval.¹ Abbott plans to build SimpleScreen CRC commercialization on the provider relationships, reimbursement infrastructure, and patient support programs it established through Cologuard, including its Nexus platform for connecting patients to screening.¹ Abbott intends to launch the test this fall, positioning it as an additional noninvasive option alongside Cologuard rather than a replacement for it.¹

Freenome described plans to incorporate SimpleScreen CRC into its broader SimpleScreen portfolio while continuing development of additional single- and multi-cancer blood tests on the same multiomics platform.¹ The company describes the approval as the first commercial milestone in its Personalized Cancer Detection strategy, which pairs risk-based screening with test performance tailored to specific indications.¹

“The fact is that 90% of colorectal cancer deaths are preventable, yet the disease will still claim more than 55,000 lives in the U.S. this year alone,” said Anjee Davis, MPAA, CEO of Fight Colorectal Cancer. “Regular screening is the key to reversing that trend, and new, minimally invasive screening options that help more people get screened are a critical part of that process. Colorectal cancer is increasingly affecting younger adults, and a screening test that fits into a routine visit, accompanied by prompt follow-up in response to an abnormal result, can play an important role in driving earlier treatment and prevention.”

References

1. Freenome. FDA Approves Freenome’s SimpleScreen™ CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S. July 27, 2026. Accessed July 27, 2026. https://www.globenewswire.com/news-release/2026/07/27/3333470/0/en/FDA-Approves-Freenome-s-SimpleScreen-CRC-Blood-Based-Screening-Test-Abbott-to-Commercialize-in-the-U-S.html

2. Exact Sciences. FDA Approves Exact Sciences’ Cologuard Plus™ Test, Setting A New Benchmark in Non-Invasive Colorectal Cancer Screening. October 4, 2024. Accessed July 27, 2024. https://www.exactsciences.com/newsroom/press-releases/fda-approves-exact-sciences-cologuard-plus-test