Freenome, Inc. FRNM
Freenome, Inc. (Nasdaq: FRNM) is an oncology diagnostics company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| SimpleScreen CRC (cfDNA blood test) | Colorectal cancer screening; FDA-approved July 2026, Abbott holds exclusive US commercial rights as standalone test | unclear | NA_NON_THERAPEUTIC |
| SimpleScreen Lung (laboratory-developed test) | Lung cancer screening, ages 50-80 with >=20 pack-year history; launched Oct 20, 2026 as LDT, not FDA reviewed | unclear | NA_NON_THERAPEUTIC |
| Multi-cancer / additional single-cancer tests (Personalized Cancer Detection pipeline) | Additional cancer indications | unclear | NA_NON_THERAPEUTIC |
Recent results and decisions
- Oct 20, 2026positive SimpleScreen Lung achieved 85% sensitivity at 50% specificity and 99.8% negative predictive value in an independent cohort of adults ages 50 to 80 with ≥20 pack-year smoking history.
In an independent cohort of 172 lung cancer cases and 436 controls, the test achieved 85% sensitivity at 50% specificity and a 99.8% negative predictive value (NPV).
Filing - Oct 20, 2026n/a Freenome launched SimpleScreen Lung laboratory-developed test and a combined offering enabling screening for both lung and colorectal cancer through a single blood draw.
Freenome announced the launch of SimpleScreen Lung and a first-of-its-kind offering that enables eligible patients to be screened for both lung and colorectal cancer (CRC) through a single blood draw, using two independently validated, indication-specific tests.
Filing - Jul 27, 2026approval FDA approved SimpleScreen CRC blood-based CRC screening test; PREEMPT CRC showed 81.1% sensitivity for CRC and 90.4% specificity for advanced neoplasia; $100M milestone from Abbott triggered.
Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based screening tests, and Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved SimpleScreen™ CRC
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other oncology companies
- Guardant Health, Inc. GH
- Caris Life Sciences, Inc. CAI
- GRAIL, Inc. GRAL
- NovoCure Ltd NVCR
- Personalis, Inc. PSNL
- AnaptysBio, Inc. ANAB
- Alpha Tau Medical Ltd. DRTS
- Castle Biosciences Inc CSTL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.