Freenome, Inc.: launches SimpleScreen Lung and dual lung/CRC blood test

What happened Freenome, Inc. announced on Oct 20, 2026 that it launched SimpleScreen Lung and an offering that enables eligible patients to be screened for both lung and colorectal cancer through a single blood draw using two independently validated, indication-specific tests. The company furnished a press release under Regulation FD (Exhibit 99.1) and included customary forward-looking statements.

Key details

• SimpleScreen Lung was clinically validated in a case-control study of adults ages 50 to 80 with a ≥20 pack-year smoking history who meet American Cancer Society lung cancer screening eligibility.
• In an independent cohort of 172 lung cancer cases and 436 controls, SimpleScreen Lung achieved 85% sensitivity at 50% specificity and a 99.8% negative predictive value; sensitivity was 82% for stage I, 75% for stage II, 91% for stage III, and 94% for stage IV.
• Intended use includes former smokers regardless of how long ago they quit, consistent with the 2023 American Cancer Society lung cancer screening guideline update.
• In the PREEMPT CRC study (more than 48,000 participants), the colorectal test demonstrated 81% sensitivity for colorectal cancer, 90% specificity for advanced colorectal neoplasia, and a 99.9% negative predictive value (analysis adjusted to the 2020 U.S. Census age and sex distribution).

Why it may matter

• Item 8.01 (Other events) reports the launch and clinical performance details described above. Item 7.01 (Regulation FD disclosure) furnishes the press release as Exhibit 99.1. A filing does not show why the insider traded or why the company acted.