The FDA just put Freenome’s lung cancer blood test on a fast track. SimpleScreen Lung is an AI-powered multiomic screen, and the breakthrough designation came August 12. It lands roughly two weeks after the agency cleared Freenome’s colorectal screening blood test.
SimpleScreen Lung runs machine learning over methylation and proteomic signals measured from a standard blood draw. The proposed use targets adults aged 50 to 80 with at least a 20 pack-year smoking history who are not currently in guideline-recommended screening. A positive result points patients to follow-up low-dose CT imaging, while a negative result does not rule out cancer.
The designation follows development data presented at the AACR annual meeting. Across 363 lung cancer cases and 310 cancer-negative controls, the test posted 90.7 percent sensitivity at 50 percent specificity and 80.4 percent at 75 percent specificity, adjusted for the intended use population.
A prospective trial called PROACT LUNG is now testing real-world sensitivity and specificity. Freenome CEO Aaron Elliot called the designation a recognition of the unmet need in lung screening that speeds the road to patients.
Low-dose CT remains the screening standard, but strict eligibility rules, radiation concerns and limited awareness keep many high-risk smokers untested. A simple blood draw could widen access, with CT reserved for those who screen positive.
