Freenome Expands Personalized Cancer Detection Portfolio, Launching SimpleScreen™ Lung Test With FDA-Approved SimpleScreen CRC Option
Globe Newswire•20/10/2026•08:30 ET
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Key Highlights
- ➤Freenome launched SimpleScreen Lung, enabling lung and CRC screening through one blood draw
- ➤SimpleScreen Lung delivered 85% sensitivity, 50% specificity, and 99.8% negative predictive value
- ➤SimpleScreen Lung has not been reviewed, cleared, or approved by the FDA
- ➤FDA-approved SimpleScreen CRC showed 81% sensitivity, 90% specificity, and 99.9% negative predictive value
- ➤Abbott holds exclusive U.S. commercial rights to standalone SimpleScreen CRC orders
Expert Statements
Douglas Flora, M.D., Executive medical director of oncology services for St. Elizabeth Healthcare and president-elect of the Association of Cancer Care Centers
“Lung cancer screening can save lives, but its potential depends on reaching people who are eligible. When so many people are not up to date, we need to understand what is keeping them from participating and consider new approaches. A blood-based test adds a practical option to our patient conversations and helps us make progress toward our goal of connecting more eligible people with screening and getting them to take the next step.”
Aaron Elliott, Ph.D., CEO of Freenome
“SimpleScreen CRC proved what our discovery platform can achieve for colorectal cancer screening, and expanding into lung cancer screening is the next step in extending this science to broader patient populations. By coupling indication-specific screens together, we make it vastly easier for patients to say yes to screening. As our portfolio grows, Personalized Cancer Detection will offer clinicians more screening options and enable health systems to provide more comprehensive coverage without adding complexity to existing clinical workflows.”
– Personalized Cancer Detection provides flexible approach to cover multiple types of cancer screening in a single blood draw –
– In an independent cohort, SimpleScreen Lung showed 85% sensitivity at 50% specificity and a 99.8% negative predictive value for lung cancer in its intended use population –
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