What the FDA actually granted. Breakthrough Device Designation is a review program. It gives a company faster and more interactive access to FDA staff while a device is still investigational. It says nothing about whether the test works well enough to sell. Freenome is still running the prospective PROACT LUNG study (NCT06122077), and clearance is a separate decision that has not happened.
Sensitivity is the number the headlines used. In development data presented at the 2026 AACR annual meeting, across 363 lung cancer cases and 310 cancer-negative controls, SimpleScreen Lung reached an intended-use-population-adjusted sensitivity of 90.7%. Sensitivity is how often a test catches the disease when it is there. Catching nine of ten cancers from a standard blood draw would be a real result.
Specificity is the number underneath it. That 90.7% figure came at 50% specificity. Specificity is how often a test correctly clears people who do not have the disease, so 50% means half the cancer-free people tested also return a positive signal. Freenome reported the second operating point too: 80.4% sensitivity at 75% specificity. Every screening test trades one against the other, and a single accuracy percentage quoted on its own tells you which half of the trade someone chose to show you.
The comparison is not a CT scan. The proposed use is narrower than "a blood test for lung cancer." It targets adults 50 to 80 with at least a 20 pack-year smoking history who are not currently participating in guideline-recommended screening. For that group the recommended screening is an annual low-dose CT, and the pitch here is reaching people who are not getting one. A blood draw that pulls unscreened people into the system is a different proposition from a blood draw that replaces imaging.
This is Freenome's second FDA milestone of 2026, and they are not the same milestone. The FDA approved the company's SimpleScreen CRC colorectal test in July. That one is a decision to allow a test onto the market. This one is a decision to review a different test faster. Two milestones, two very different meanings, one company.
For anyone reading their own panel right now, none of this shows up on it. Lung cancer screening is not a line item on a standard blood panel, and this test will not be for some time.
Freenome cleared a much bigger bar in July with a different test. See the FDA-approved blood test for colorectal cancer for what an actual approval looks like.