Key Takeaways
- Freenome shares fell 11% today after an updated version of its SimpleScreen CRC blood test raised precancer detection to 18.2%, up from 13.7%.
- The selloff looks fair: cancer detection held at 80.4%, and the test still misses more than four in five precancerous lesions.
- Analysts expect revenue to grow from $102 million in fiscal 2026 to $208 million in fiscal 2028, as Abbott sells the first-generation test it launched in late September.
- The detailed results come at the ACG meeting on Wednesday, Oct. 14.
Freenome (FRNM) shares are down 11% today. On Sunday afternoon, the company released new data on an updated version of its SimpleScreen CRC blood test.
CEO Aaron Elliott called the results “clinically meaningful.” The market doesn’t seem to agree.
What exactly happened
Freenome ran a pivotal validation study on changes to the test’s assay and algorithm. Compared with the original PREEMPT CRC study:
- Sensitivity for advanced precancerous lesions rose to 18.2%, from 13.7%.
- Sensitivity for lesions with high-grade dysplasia rose to 41.9%, from 30.5%.
- Colorectal cancer detection stayed level with the first version, at 80.4% sensitivity at 90% specificity.
Freenome says no non-invasive screening blood test has reported higher precancer figures in a prospective registrational study. In Elliott’s words, “These results suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity.”
Note the “may.”
Why the market wanted more
The precancer gain matters. Catching lesions before they turn into cancer is how screening prevents cancer in the first place. But at 18.2%, the test still misses more than four out of five of those lesions. And cancer detection, the first number anyone checks on a screening test, didn’t improve at all.
The timing adds pressure. The FDA approved the first-generation test in July, and Abbott (ABT) Cancer Diagnostics launched it in late September. Freenome plans to keep improving the test, version after version. Elliott calls this approach “a fundamental part of our up-versioning strategy.”
What’s next
Analysts expect revenue to roughly double between fiscal 2026 and fiscal 2028, according to the consensus of five analysts as of Aug. 20.
Those estimates rest on the test Abbott is selling now, and Sunday’s data doesn’t change that test. I don’t see a reason for analysts to cut their numbers on this news.
Of course, every new version needs its own validation study, and Freenome pays for those while the first test is still ramping up.
To me, the selloff makes sense. The upgrade made gains on precancers, a measure that matters less to a screening test’s case than cancer detection, and the cancer number didn’t move.
Still, a press release only gives the headline figures. Dr. Aasma Shaukat of NYU Grossman School of Medicine, a co-lead principal investigator on PREEMPT CRC, presents the detailed results at ACG in Nashville on Wednesday, Oct. 14.
So what is Freenome stock actually worth?
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