Freenome, Inc. 8-K

What Happened

• Freenome filed an 8-K on July 27, 2026 announcing that the U.S. Food and Drug Administration approved SimpleScreen™ CRC, a blood-based colorectal cancer (CRC) screening test for average-risk adults aged 45 and older. Abbott will exclusively commercialize the test in the U.S. under an agreement dated August 2025.

Key Details

• FDA approval is based on PREEMPT CRC, a prospective study run at over 200 sites that enrolled more than 48,000 asymptomatic, average‑risk adults (ages 45–85).
• Test performance (prespecified, census-adjusted analysis): 81.1% sensitivity for colorectal cancer, 13.7% sensitivity for advanced precancerous lesions (30.7% for APLs with high‑grade dysplasia), and 90.4% specificity for advanced colorectal neoplasia.
• Under the Freenome–Abbott commercial agreement, Freenome will receive a $100 million milestone payment tied to this FDA approval.
• With approval, SimpleScreen CRC meets Medicare coverage criteria and is expected to be incorporated by name into American Cancer Society guidelines.

Why It Matters

• FDA clearance and an exclusive U.S. commercialization partner (Abbott) are major commercialization milestones that should help Freenome broaden access and reimbursement for its first approved product. The $100M milestone payment is immediate, material cash consideration tied to the approval.
• The reported sensitivity/specificity figures give investors concrete measures of clinical performance versus existing screening options; the large PREEMPT CRC study (48,000+ participants) supports the regulatory decision.
• Coverage by Medicare and likely inclusion in ACS guidelines could materially affect uptake and revenue potential, while Abbott’s existing CRC infrastructure (e.g., Cologuard relationships and Nexus platform) may accelerate market adoption.

(Report items: 7.01 Regulation FD disclosure; 8.01 Other events — FDA approval disclosed in press release furnished as Exhibit 99.1.)