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Freenome reports $183.5M Q3 revenue after FDA approval of SimpleScreen CRC blood test

🇺🇸 Freenome, Inc. (FRNM) · Tue 10 Nov 2026

The US firm's third-quarter revenue was driven mainly by licence income after the FDA approved its blood-based colorectal cancer screening test, which Abbott has since launched.

Freenome reported revenue of $183.5 million for the third quarter ended 30 September 2026. The company said the result was driven mainly by licence revenue, which followed the US Food and Drug Administration's approval of its SimpleScreen CRC test.

The FDA approved SimpleScreen CRC on 24 July 2026. It is a blood-based colorectal cancer screening test for adults aged 45 and over at average risk of the disease. According to the company, the approval triggered a $100 million milestone.

Abbott launched the test in the US on 30 September under a licence agreement that was originally struck with Exact Sciences.

Freenome also launched SimpleScreen Lung in October and has received FDA Breakthrough Device Designation for a multiomics version of its lung test. For the full year, it guided 2026 revenue to between $192 million and $194 million.

What it means for your team

  • Approval of a blood-based colorectal screening test for average-risk adults aged 45 and over adds a new non-stool, non-endoscopic option to the US screening landscape.
  • Market-access teams should watch how payers and screening guidelines treat the test now that Abbott has launched it commercially.
  • Breakthrough Device Designation for the multiomics lung test signals that the FDA's expedited-development pathway is in play for that programme, though it is not an approval.
  • The licence-driven revenue shows how regulatory milestones can translate directly into financial results under partnered commercialisation deals.

Company's press release (SEC filing): Freenome, Inc. ↗

Article written by VigiEye from the official source (Freenome, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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