Freenome, Inc.

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. rights to standalone SimpleScreen CRC.

•12d ago

Freenome to Present New Validation Data for Next-Generation CRC Screening Test in Late-Breaking Oral Presentation at ACG 2026

Freenome will present late-breaking validation data for its updated SimpleScreen CRC blood test at the ACG 2026 Annual Meeting on Oct. 14. The updated test showed 18.2% sensitivity for advanced precancerous lesions, up from 13.7% previously, and 41.9% for high-grade dysplasia lesions versus 30.5% — described as the highest reported for any non-invasive screening blood test in a pivotal registrational study. Overall CRC detection held at 80.4% sensitivity with 90% specificity. The first-generation test received FDA approval in July 2026 and was commercially launched in late September by partner Abbott Cancer Diagnostics.

•21d ago

FDA Grants Breakthrough Device Designation to Freenome’s Blood-Based SimpleScreen™ Lung Cancer Screening Test

Freenome announced that the FDA granted Breakthrough Device Designation to its SimpleScreen Lung test, accelerating the development and review of this investigational blood-based screening tool for adults at high risk for lung cancer. The designation is aimed at addressing the substantial screening gap, as only 18% of eligible U.S. adults currently undergo recommended screening, by offering a non-invasive alternative to low-dose computed tomography (LDCT). SimpleScreen Lung utilizes the company's multiomics platform, which also underpins the recently approved SimpleScreen CRC colorectal cancer test, and is currently undergoing clinical evaluation in the PROACT LUNG study.

•2mo ago

FDA Approves Freenome’s SimpleScreen™ CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S.

The FDA approved Freenome's SimpleScreen CRC blood-based screening test for colorectal cancer in average-risk adults 45 and older. Abbott will exclusively commercialize the test in the U.S. starting this fall and will pay Freenome a $100 million milestone payment upon approval. Clinical validation data from the PREEMPT CRC study showed 81.1% sensitivity for colorectal cancer and 90.4% specificity.

•3mo ago