Freenome Expands Personalized Cancer Detection Portfolio, Launching SimpleScreen™ Lung Test With FDA-Approved SimpleScreen CRC Option
Freenome launched SimpleScreen Lung, a blood-based laboratory-developed test for adults 50-80 with a ≥20 pack-year smoking history, orderable alone or alongside its FDA-approved SimpleScreen CRC test in a single blood draw. In an independent case-control cohort (172 cases, 436 controls), the lung test showed 85% sensitivity at 50% specificity and a 99.8% negative predictive value. The launch extends the screening portfolio into lung cancer, where more than 10 million screening-eligible Americans are not up to date with LDCT, but the lung test has not been FDA-reviewed and Abbott retains exclusive U.S.
Key figures
- Drug Name
- SimpleScreen Lung
- Crc npv
- 99.9%
- Lung npv
- 99.8%
- Crc sensitivity
- 81%
- Crc specificity
- 90% for advanced colorectal neoplasia
- Lung sensitivity
- 85% at 50% specificity
- Validation cohort
- 172 lung cancer cases and 436 controls
- Preempt crc enrollment
- more than 48,000 participants
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.