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Freenome (Nasdaq: FRNM) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to SimpleScreen™ Lung, its investigational blood-based lung cancer screening test. The designation covers adults ages 50–80 with at least a 20 pack-year smoking history who are not currently undergoing guideline-recommended lung cancer screening.
The AI-powered multiomic test is intended to detect early signals of lung cancer from a standard blood draw and be ordered by healthcare providers. According to Freenome, the FDA Breakthrough Devices Program enables interactive communication and prioritized review during premarket submission. SimpleScreen Lung builds on the company’s methylation and next-generation sequencing platform already used in the FDA-approved SimpleScreen CRC colorectal cancer screening test.
The test combines methylation and proteomics with an AI/ML classifier to determine whether a lung cancer signal is detected. A positive result would indicate a signal that may suggest lung cancer and should be followed by low-dose CT imaging; a negative result does not rule out lung cancer. Freenome is continuing clinical evaluation, including the prospective PROACT LUNG study (NCT06122077), after reporting initial development data at the 2026 AACR Annual Meeting.
Freenome (Nasdaq: FRNM) received FDA approval for SimpleScreen™ CRC, a blood-based colorectal cancer (CRC) screening test for average-risk adults aged 45+ that uses a simple blood draw to detect CRC signals from cell-free DNA. Abbott (NYSE: ABT) will exclusively commercialize the test in the U.S. starting this fall.
In the >48,000‑participant PREEMPT CRC study, SimpleScreen CRC showed 81.1% sensitivity for CRC, 13.7% sensitivity for advanced precancerous lesions (30.7% with high‑grade dysplasia) and 90.4% specificity for advanced colorectal neoplasia. With approval, the test meets Medicare coverage criteria and is expected to be named in American Cancer Society guidelines, supporting broader access for up to 60 million Americans overdue for screening. Under their August 2025 commercial agreement, Freenome will receive a $100 million milestone payment from Abbott tied to this approval. Freenome plans to integrate SimpleScreen CRC into its wider SimpleScreen portfolio and Personalized Cancer Detection platform.
Freenome (Nasdaq: FRNM) announced the closing of its business combination with Perceptive Capital Solutions Corp, creating a combined company renamed Freenome that is expected to begin trading on the Nasdaq Capital Market on July 21, 2026 under ticker FRNM.
The transaction is expected to deliver approximately $310 million in gross proceeds, including about $70 million from the former PCSC trust account and a fully committed $240 million PIPE led by Perceptive Advisors and RA Capital, with participation from several other healthcare investors. According to Freenome, this capital will support its blood-based early cancer detection portfolio, AI/ML-enabled multiomics platform, and commercialization efforts, including colorectal and lung cancer programs and more than 10 additional indications. The company outlines three focus pillars: advancing its comprehensive cancer detection portfolio, enhancing its AI-enabled multiomics platform, and scaling commercial, lab and digital infrastructure, supported by partnerships with Abbott and Roche.