Every material Form 8-K Freenome, Inc. has filed with the SEC since July 23, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Freenome announced on October 20, 2026 the launch of SimpleScreen Lung, a laboratory-developed lung cancer blood test, and an offering that lets eligible patients be screened for lung and colorectal cancer through a single blood draw. The filing reports clinical validation data but no financial results, guidance, or financial terms, so the announcement gives shareholders no direct read on revenue or profit.
SimpleScreen Lung showed 85% sensitivity at 50% specificity and a 99.8% negative predictive value in an independent cohort of 172 lung cancer cases and 436 controls.
SimpleScreen Lung has not been reviewed or cleared or approved by the FDA; the SimpleScreen CRC test is FDA-approved for adults 45 and older at average risk.
Abbott has exclusive U.S. commercial rights to SimpleScreen CRC when it is ordered as a standalone test.
The launch was announced October 20, 2026, and the company will show the portfolio at the FMX conference in Nashville, October 20 to 24.
The FDA approved Freenome's SimpleScreen CRC, a blood-based colorectal cancer screening test for adults 45 and older at average risk. Under an August 2025 agreement, Freenome will receive a $100 million milestone payment from Abbott, which will exclusively commercialize the test in the U.S. this fall.
FDA approved SimpleScreen CRC for adults 45 and older at average risk for colorectal cancer, announced July 27, 2026.
In the PREEMPT CRC study of more than 48,000 adults, the test showed 81.1% sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia.
Freenome will receive a $100 million milestone payment from Abbott for the FDA approval; Abbott plans to commercialize the test in the U.S. this fall.
Freenome completed its business combination with PCSC, and the filing details the post-closing arrangements. Approximately 65,440,613 shares, about 60.9% of New Freenome common stock, are subject to registration rights, and Sponsor and certain former Freenome stockholders are restricted from transferring shares for six months after closing. Shareholders should note the potential for future resales and the new equity plans, which add shares available for issuance.
Amendment No. 1, dated July 20, 2026, reduced New Freenome's board from nine to seven directors following the Closing.
Under the Investor Rights Agreement, New Freenome must file a resale registration statement within 30 calendar days after the Closing Date.
Lock-up agreements bar transfers, with certain permitted exceptions, until six months after the Closing Date.
The 2026 Equity Incentive Plan initially reserves 14,773,227 shares, and the 2026 Employee Stock Purchase Plan initially reserves 2,462,204 shares.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
Only material 8-Ks get a brief: results, deals, executive changes, restructuring, impairments, delisting notices, restatements, cybersecurity incidents and other disclosed events. Routine filings (vote results, exhibits only) are skipped. Every Freenome, Inc. filing is on SEC EDGAR ↗. 8-K briefs of other companies →