The U.S. Food and Drug Administration (FDA) has approved SimpleScreen CRC, a new blood-based screening option for colorectal cancer in adults aged 45 years and older who are at average risk for the disease. The test is produced by Freenome, an early cancer detection company, and Abbott will exclusively commercialize the test in the United States starting in the fall.

SimpleScreen CRC detects molecular signals associated with advanced colorectal neoplasia, including both colorectal cancer and advanced precancerous lesions, from circulating cell-free DNA (cfDNA) in the blood. The test analyzes DNA methylation patterns with cfDNA sequencing and propriety software that includes an AI/machine learning–enabled classification algorithm.

“SimpleScreen CRC is the first commercial realization of our Personalized Cancer Detection strategy, built on base-level cfDNA methylation and AI-enhanced accuracy,” said Aaron Elliott, PhD, CEO of Freenome.

The FDA approval expands options for patients undergoing colorectal cancer screening, including for the up to 60 million Americans who are overdue for recommended screening.

“The most effective screening test is the one a person will actually complete,” said Aasma Shaukat, MD, MPH, Professor of Medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study. “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 now meets Medicare coverage criteria and is expected to be included in the American Cancer Society guidelines for colorectal cancer screening, both of which will help expand access to blood-based colorectal cancer screening for eligible adults.

PREEMPT CRC

The blood-based test was evaluated in PREEMPT CRC, the largest prospective clinical validation study ever conducted for a blood-based colorectal cancer screening test. The study was conducted at over 200 sites and enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 years who were scheduled for a screening colonoscopy.

In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC achieved 81.1% sensitivity for detecting colorectal cancer and 13.7% sensitivity for detecting advanced precancerous lesions, including 30.7% sensitivity for advanced precancerous lesions with high-grade dysplasia. The test demonstrated 90.4% specificity for detecting advanced colorectal neoplasia. Overall, the test detected about 8 in 10 colorectal cancers and showed negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.

“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, Chief Executive Officer 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.”

The test is indicated for adults aged 45 years and older who are at average risk for colorectal cancer and referred by a health-care provider for colorectal cancer screening. A positive result indicates a signal was detected that may suggest the presence of colorectal cancer or advanced precancerous lesions and should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

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