A new blood test designed to help doctors diagnose colorectal cancer, the second-leading cause of cancer deaths in the US, has been approved by the Food and Drug Administration. The test, called SimpleScreen, is made by California-based biotech company Freenome and is intended for adults aged 45 and older who are at average risk for the disease. SimpleScreen is designed to detect DNA signals linked to colorectal cancer in this age group.
The test involves a blood draw at a doctor’s office, with results returned in just a couple of weeks. If the test comes back positive, patients will need a colonoscopy to confirm the presence of cancer. According to Dr. Aasma Shaukat, a professor of medicine at NYU Grossman School of Medicine, 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. The study, which included more than 48,000 average-risk adults aged 45-85, found that SimpleScreen detected about eight in 10 colorectal cancers, while producing correct negative results for nine in ten people without colorectal cancer or advanced precancerous lesions. SimpleScreen is the second approved test by the FDA for colorectal cancer screening, following Guardant Health’s Shield test, which was approved in 2024.
However, further investigation is needed to determine the comparative effectiveness of SimpleScreen with other FDA-approved screening modalities. The test is expected to be made available to patients this fall in partnership with Illinois healthcare company Abbott, although the cost is not yet known. In contrast, Shield is free for patients with Medicare Part-B, while those without Medicare may have out-of-pocket prices up to $1,495.
The approval of SimpleScreen comes as the rates of colorectal cancer are spiking in the US, especially among young adults. This year, nearly 109,000 new cases of colon cancer and close to 50,000 new cases of rectal cancer are expected, according to the American Cancer Society. The disease is predicted to be the leading cause of cancer death for people under 50 by 2030, with more than 55,000 deaths forecast in 2026.
