Freenome Receives FDA Breakthrough Designation for SimpleScreen Lung Cancer Test

FDA awarded breakthrough device designation to Freenome’s SimpleScreen, a blood‑based lung cancer screening test, signaling the agency’s intent to accelerate review of technologies that show potential to address unmet medical needs.

Freenome indicated the designation will enable the company to engage more closely with regulators, shorten the timeline for clinical trials, and move toward market availability faster than standard approval pathways.

SimpleScreen relies on a single blood draw to detect circulating tumor DNA and other biomarkers associated with early‑stage lung tumors, offering a less invasive option compared with low‑dose CT scans currently used for screening.

Lung Cancer Screening experts suggest that if SimpleScreen demonstrates high sensitivity, it could expand screening to broader populations, improve early detection rates, and ultimately increase survival outcomes for high‑risk individuals.