---
title: "Freenome's SimpleScreen CRC gains FDA approval; $100M Abbott milestone, Medicare coverage expected"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/293930769.md"
description: "Freenome announced FDA approval for SimpleScreen CRC, a blood-based colorectal cancer screening test for average-risk adults aged 45 and older. The approval follows the PREEMPT CRC study showing high sensitivity and specificity. Under a 2025 commercial deal, Abbott will exclusively commercialize the test in the U.S., triggering a $100 million milestone payment for Freenome. Medicare coverage is expected, and the test may be included in American Cancer Society guidelines."
datetime: "2026-07-27T12:13:00.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/293930769.md)
  - [en](https://longbridge.com/en/news/293930769.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/293930769.md)
generator: "portal-rs"
---

# Freenome's SimpleScreen CRC gains FDA approval; $100M Abbott milestone, Medicare coverage expected

**Freenome announced FDA approval of SimpleScreen CRC, a blood-based colorectal cancer screening test and a $100 million Abbott milestone payment.**

**Key Highlights:**

-   FDA approved SimpleScreen CRC for average-risk adults 45+ as a blood-based CRC screening option, expanding screening choices.
-   PREEMPT CRC study (48,000+ participants) showed 81.1% sensitivity for CRC, 13.7% for APLs, and 90.4% specificity for advanced neoplasia.
-   Approval meets Medicare coverage criteria and is expected to be named in American Cancer Society guidelines, broadening access.
-   Under the 2025 commercial deal, Abbott will exclusively commercialize the test in the U.S.; Freenome receives a $100 million milestone payment.
-   Freenome plans to integrate SimpleScreen CRC into its SimpleScreen portfolio and continue developing additional single- and multi-cancer tests.

Original SEC Filing: Freenome, Inc. \[ PCSC \] - 8-K - Jul. 27, 2026

**Disclaimer**

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.

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---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**