FDA Grants Breakthrough Status to Freenome's Lung Cancer Blood Test
FRNM sits 24% above its 52-week low of $9.95 on elevated volume (3.3× avg).
Summary
The FDA awarded Breakthrough Device Designation to Freenome's SimpleScreen Lung, a blood-based screening test for high-risk adults not currently getting guideline-recommended LDCT scans. This follows last month's FDA approval of the company's colorectal cancer screening test, SimpleScreen CRC, and extends the same multiomics platform into the much larger lung cancer screening market. The designation provides a faster, more interactive review pathway, materially de-risking the regulatory timeline. Lung cancer is the leading cause of cancer death in the U.S., yet only 18% of eligible adults are screened — a blood test could significantly expand the addressable market. The company is continuing its PROACT LUNG prospective study to support an eventual FDA submission.
At the time of this announcement, FRNM was trading at $12.29 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.3B. The 52-week trading range was $9.95 to $14.47. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.