FDA Approves Second Blood Test for Colorectal Cancer Screening
The U.S. FDA has approved SimpleScreen CRC, a blood-based screening test for adults aged 45 years and older who are at average risk of colorectal cancer. Developed by Freenome, it becomes the second FDA-approved blood test for colorectal cancer screening, following Guardant Health's Shield test, expanding non-invasive screening options and potentially improving screening uptake.
Abbott will exclusively commercialize the test in the U.S. this fall, expanding its CRC screening portfolio with a new option that requires only a simple blood draw.
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., but it is highly preventable and treatable when detected early through screening. Up to 60 million Americans remain overdue for recommended screening,1 underscoring the need for additional convenient screening approaches that can help reach more people.
“The most effective screening test is the one a person will actually complete,” said Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC® study.2 “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 detects signals associated with colorectal cancer from cell-free DNA (cfDNA) in the blood. FDA approval reflects years of clinical research, AI/ML-driven technology development and extensive collaboration with investigators, healthcare providers and partners.
SimpleScreen CRC was evaluated in PREEMPT CRC, the largest prospective clinical validation study ever conducted for a blood-based colorectal cancer screening test. Conducted at over 200 sites, PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 who were scheduled for a screening colonoscopy. In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions (APLs) with 13.7% sensitivity, including 30.7% for APLs with high-grade dysplasia. The test showed 90.4% specificity for advanced colorectal neoplasia. In practical terms, the test correctly detected about 8 in 10 colorectal cancers while correctly producing negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.
“Today’s approval is an important validation of the scientific vision we’ve spent more than a decade building,” said Aaron Elliott, Ph.D., CEO of Freenome. “SimpleScreen CRC is the first commercial realization of our Personalized Cancer Detection strategy, built on base-level cfDNA methylation and AI-enhanced accuracy. We believe this common technology foundation will power our expanding portfolio of cancer screening tests, continuous performance improvements and future product generations as our platform continues to learn.”
“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,” added 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.”
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare and is expected to be incorporated into the American Cancer Society guidelines by name. Together, these milestones help expand access to blood-based CRC screening for eligible adults.
Under the terms of the commercial agreement signed between Freenome and and Abbott in August 2025, Freenome will receive a $100 million milestone payment from Abbott for this FDA approval. Abbott will exclusively commercialize SimpleScreen CRC in the U.S., building on the provider relationships, reimbursement expertise and patient support programs it has developed through Cologuard®. The company’s established CRC infrastructure – including its Nexus platform – will help connect more people to screening and support adoption across the healthcare system.
“FDA approval is a significant milestone in our mission to help more people get screened, detect colorectal cancer earlier and ultimately help save lives,” said Jake Orville, senior vice president of Abbott’s cancer diagnostics business. “No single screening option will reach every patient. By adding SimpleScreen CRC alongside Cologuard, we are expanding the choices available to healthcare providers and helping remove barriers that keep too many people from getting screened.”
For Freenome, the approval marks the first commercial milestone in Freenome’s Personalized Cancer Detection approach, which combines risk-based screening with test performance optimized and tailored to specific indications, all through a single blood draw. The company also plans to incorporate SimpleScreen CRC into its broader SimpleScreen portfolio, while continuing to advance additional single- and multi-cancer tests, built on the same multiomics platform.
