Freenome Launches SimpleScreen Lung, Bundles Lung and CRC Screening in One Blood Draw
FRNM sits 22% above its 52-week low of $9.95.
Summary
Freenome launched SimpleScreen Lung, a lab-developed blood test for adults 50-80 with a 20+ pack-year smoking history, and paired it with its FDA-approved SimpleScreen CRC test so eligible patients can be screened for both cancers from a single draw. The lung test is not FDA reviewed or cleared — it is being marketed as an LDT, which limits reimbursement and leaves it exposed to regulatory scrutiny. Validation in an independent cohort of 172 cases and 436 controls showed 85% sensitivity at 50% specificity and a 99.8% negative predictive value, with stage I sensitivity of 82%. The commercial logic is real: fewer than 20% of the roughly 10 million lung-screening-eligible Americans are up to date on LDCT, and up to 60 million eligible adults are behind on CRC screening. Note Abbott holds exclusive U.S. commercial rights to SimpleScreen CRC when ordered standalone, so the bundled offering is where Freenome captures the combined order. This follows the August Breakthrough Device Designation for SimpleScreen Lung and the July FDA approval of SimpleScreen CRC. The company is showcasing the portfolio at the AAFP FMX conference in Nashville, Oct. 20-24.
At the time of this announcement, FRNM was trading at $12.13 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.4B. The 52-week trading range was $9.95 to $17.50. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.