FDA Grants Breakthrough Status to Freenome's Lung Blood Test

Freenome's second cancer-screening blood test in as many months has FDA's attention. On 12 August 2026 the company announced that FDA granted Breakthrough Device Designation to SimpleScreen Lung, an investigational test aimed squarely at a gap in lung cancer screening: people old enough and at high enough risk to qualify for a CT scan, who are not getting one.

The gap this test is aimed at

Low-dose CT screening for lung cancer already exists and is guideline-recommended for current and former heavy smokers, but FDA's designation is explicit about who SimpleScreen Lung is meant for: adults 50 to 80 with a 20-pack-year-or-greater smoking history who are eligible for that screening but are not enrolled in it. A blood draw is a lower-friction ask than scheduling and returning for an annual CT scan, and Freenome's bet is that a test primary care can order alongside routine bloodwork reaches patients that a referral to imaging does not. The test would not replace LDCT screening for people already getting it — it is positioned as a way to catch the population that has fallen through that referral gap.

How SimpleScreen Lung works

The test analyzes DNA methylation and protein signals from a standard blood draw and runs them through an AI/ML-powered classifier trained to identify patterns associated with lung cancer. Freenome presented initial development data at the 2026 AACR Annual Meeting: in a set of 363 lung cancer cases and 310 cancer-negative controls, the intended-use-population-adjusted sensitivity was 90.7 percent at 50 percent specificity, and 80.4 percent at 75 percent specificity — the kind of sensitivity/specificity trade-off screening tests are built around, since a test tuned too loose overwhelms follow-up imaging with false positives, and one tuned too tight misses cancers.

What Breakthrough status actually buys

Breakthrough Device Designation is not a clearance or an approval, and SimpleScreen Lung has not been submitted to FDA for marketing authorization. What it grants is process: more frequent, interactive communication with FDA's review staff during development, and priority handling once a submission does arrive. Freenome is continuing to validate the test through PROACT LUNG, a prospective observational study enrolling up to 20,000 current and former smokers 50 and older who are eligible for LDCT screening, across as many as 100 US sites. The study is designed to evaluate sensitivity, specificity, and positive and negative predictive value at both 12- and 24-month follow-up — the kind of prospective, real-world performance data a submission for marketing authorization would need.

A second product on the same platform

SimpleScreen Lung is not Freenome's first product built on this multiomics approach. FDA approved SimpleScreen CRC, the company's blood-based colorectal cancer screening test for average-risk adults 45 and older, on 27 July 2026; Abbott will commercialize it in the US starting this fall. That test detected colorectal cancer with 81.1 percent sensitivity and showed 90.4 percent specificity for advanced colorectal neoplasia in the PREEMPT CRC study. A working, FDA-approved product on the same underlying platform gives SimpleScreen Lung a regulatory and manufacturing track record to point to as it moves through Breakthrough Device development — though each test still stands or falls on its own clinical data.