Key Takeaways
- SimpleScreen CRC is a new FDA-approved blood test that screens for colorectal cancer.
- Patients can ask their doctor to order the test, have their blood drawn at the office, and receive results in about two weeks.
- If the test result is positive, a follow-up colonoscopy is needed to confirm cancer or precancerous growths.
Another blood test to screen for colorectal cancer has just received approval from the Food and Drug Administration.
The test, called SimpleScreen CRC, was developed by the biotech company Freenome. It’s designed to detect DNA signals associated with colorectal cancer in adults 45 and over. This is the second FDA-approved blood test for colorectal cancer screening, following Guardant Health’s Shield test.
SimpleScreen CRC will be released this fall in the United States.
“Nearly 60 million eligible Americans remain overdue for colorectal cancer screening, and no single screening option will meet the needs or preferences of every individual. All patients deserve the opportunity to be screened with a test that works best for them,” Paul Limburg, MD, chief medical officer for screening at Abbott’s cancer diagnostics business and emeritus professor of medicine at Mayo Clinic College of Medicine and Science, told Verywell in an email.
What Is the SimpleScreen CRC Test?
Starting later this year, patients can ask their healthcare provider to order the test and have their blood drawn at their doctor’s office. The sample will then be sent to Freenome’s CLIA-certified laboratory for analysis.
Results are returned to the ordering healthcare provider within about two weeks, Limburg said.
If a patient receives a positive result, they will need a follow-up colonoscopy to confirm the presence of cancer or precancerous growths. Freenome emphasized that SimpleScreen CRC is not a replacement for diagnostic or surveillance colonoscopy, especially for people at high risk of colorectal cancer.
“SimpleScreen CRC is the first commercial realization of our personalized cancer detection strategy, built on base-level cfDNA methylation and AI-enhanced accuracy,” Aaron Elliott, PhD, CEO of Freenome, said in a press release.
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How Accurate Is the Test?
The test was submitted for FDA approval with data from the PREEMPT CRC study, the largest prospective clinical validation study conducted to date for a blood-based colorectal cancer screening test. The study enrolled 48,995 asymptomatic adults ages 45 to 85 who were at average risk for colorectal cancer and scheduled for a screening colonoscopy.
The SimpleScreen CRC test detected 81.1% of colorectal cancer cases and 13.7% sensitivity for advanced precancerous lesions. The test also correctly identified about 9 in 10 negative results.
“Ultimately, this means that the SimpleScreen CRC test can be an effective option for people who would not otherwise screen via other recommended options, such as colonoscopy or stool-based testing,” Limburg said.
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How Does It Compare to the Shield Test?
Similar to SimpleScreen CRC, the Shield test looks for DNA fragments in the blood and analyzes whether that genetic information may have come from a cancer cell.
Guardant tested Shield in a randomized controlled trial in 2024 and found that about 83% of the 65 people who had colorectal cancer got a positive result. The test missed 17% of those cases.
Limburg said that while he couldn’t directly compare SimpleScreen CRC to Shield, he knows it is critical for people to have multiple screening options. He further pointed out that test performance data for SimpleScreen did not include other blood-based tests like Shield.
“Further investigation would be needed to appropriately determine the comparative effectiveness of SimpleScreen CRC with other FDA-approved screening modalities,” he added. “Colorectal cancer screening is not one-size-fits-all.”
