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FDA approvedFDA approved. Stage 4 of 4 (Authorized)

FDA Approves Freenome's SimpleScreen CRC Blood Test for Colorectal Cancer Screening

Abbott will sell the cell-free DNA test in the US this fall; the FDA requires a three-year post-approval study of its performance.

By News DeskJuly 27, 20262 min read
Microscope image of densely packed cells with red nuclei outlined in green
Human colon cancer cells under a microscope, with nuclei stained red and the protein E-cadherin stained green. Not related to the SimpleScreen test. NIH Image Gallery, Public domain, via Wikimedia Commons · Public domain (work of the National Institutes of Health)
FDA approvedPMA, high-risk device · P250029FDA approved. Stage 4 of 4 (Authorized)

The FDA approved this high-risk device through premarket approval (PMA), after reviewing clinical evidence of safety and effectiveness.

Key points

  • The FDA approved PMA P250029 for SimpleScreen CRC on July 24, 2026, for average-risk adults 45 and older; positive results should be followed by colonoscopy.
  • In the company-reported PREEMPT CRC analysis, sensitivity was 81.1% for colorectal cancer and 13.7% for advanced precancerous lesions, with 90.4% specificity.
  • Freenome will receive a $100 million milestone payment from Abbott, which will sell the test exclusively in the US.

The US Food and Drug Administration has approved Freenome's SimpleScreen CRC, a blood test for colorectal cancer screening in adults 45 and older at average risk, Freenome and Abbott announced on July 27. Abbott will sell the test exclusively in the US starting this fall, the companies said.

The FDA's approval letter for premarket approval application P250029 is dated July 24 and addressed to Freenome, LLC, of Brisbane, California. The application was filed on August 1, 2025, and amended in August 2025 and April 2026. The test carries product code PHP.

What the FDA approved

According to the letter, SimpleScreen CRC is a qualitative in vitro diagnostic test that detects molecular signals associated with colorectal cancer in cell-free DNA from blood plasma collected with the company's blood collection kit. It is indicated for colorectal cancer screening in adults aged 45 and older at average risk. Patients with a positive result should be followed by colonoscopy, and the test "is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals," the letter states.

As a condition of approval, the FDA requires a post-approval study that follows people prescribed the test over three years. Participants with a negative result at the start are to be offered a repeat test and a colonoscopy at year three, and the study must yield at least 1,000 evaluable participants aged 45 to 81 with both test and colonoscopy results at that point. Its co-primary measures are sensitivity for colorectal cancer, sensitivity for advanced precancerous lesions and specificity for advanced colorectal neoplasia at year three. The letter also sets a 10-month shelf life for the assay reagents.

Company-reported performance

The companies said the test was evaluated in the PREEMPT CRC study, which enrolled more than 48,000 asymptomatic, average-risk adults aged 45 to 85 who were scheduled for a screening colonoscopy, at more than 200 sites. In a prespecified analysis adjusted to match the US Census, the test detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity, including 30.7% for lesions with high-grade dysplasia, according to the release. Specificity for advanced colorectal neoplasia was 90.4%. The release cites a PREEMPT CRC paper published in JAMA in June 2025.

"Today's approval is an important validation of the scientific vision we've spent more than a decade building," said Freenome chief executive Aaron Elliott.

Abbott deal and coverage

Under a commercial agreement signed in August 2025, Freenome will receive a $100 million milestone payment from Abbott for the approval, the companies said. Abbott said it will sell the test alongside its Cologuard test. The companies said that with FDA approval the test meets Medicare's coverage criteria and is expected to be named in American Cancer Society guidelines. Pricing was not disclosed.

Sources

  1. FDA Approves Freenome's SimpleScreen CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S., Freenome, July 27, 2026
  2. PMA P250029 approval letter: SimpleScreen CRC, US Food and Drug Administration, July 24, 2026