Freenome's Colorectal Cancer Test Hits All Study Endpoints, Triggers $70M Milestone
Freenome’s test, however, didn’t meet the thresholds to get a full $100 million milestone payment from Abbott.
Freenome said July 9 that its updated SimpleScreen v2 colorectal cancer (CRC) blood test met all primary and secondary endpoints in a pivotal clinical validation study, with the biggest gains coming in detection of precancerous lesions rather than cancer itself.
The updated test showed 80 percent sensitivity for detecting colorectal cancer, including 52 percent of Stage I cases, and 100 percent of Stage II, 97 percent of Stage III and 100 percent of Stage IV cases. Sensitivity for advanced precancerous lesions (APLs) rose to 18 percent from 14 percent in the first-generation test, and sensitivity for APLs with high-grade dysplasia rose to 42 percent from 31 percent. Specificity for no findings on colonoscopy was 90 percent.
The results trigger a $70 million milestone payment under a commercialization deal with Abbott. However, that’s short of the $100 million maximum payment, according to a July 9 research note from Canaccord Genuity Analyst Kyle Mikson, “since SimpleScreen v2 did not completely meet the specified thresholds of ≥=19 percent APL sensitivity and ≥83 percent overall CRC sensitivity.”
The study readout is positive for SimpleScreen but does not suggest it will not yet be a major threat to Guardant Health’s competing Shield test. Mikson said SimpleScreen v2’s roughly 80 percent CRC sensitivity and 90 percent specificity compared with about 84 percent sensitivity for Shield v2 at a similar specificity, though SimpleScreen’s precancer detection was notably stronger. “Shield will remain the leading blood test for CRC screening going forward,” he wrote.
Freenome submitted a premarket approval application to the FDA for the first-generation SimpleScreen CRC test in August 2025; the agency’s review is expected to complete in mid-2026. The company plans to submit a supplemental PMA for the updated version.
The validation used blinded, previously unevaluated samples from the PREEMPT CRC study, a prospective registrational trial that enrolled 48,995 asymptomatic, average-risk adults ages 45 to 85 at more than 200 sites. The analysis included 89 individuals with colorectal cancer, 1,570 with advanced precancerous lesions, and 157 with APLs showing high-grade dysplasia.
Under a commercial collaboration Freenome signed with Abbott in August 2025, Abbott will exclusively commercialize SimpleScreen CRC, once it’s approved. That agreement ties a milestone payment to this study’s results; based on today’s data, the milestone will be set at $70 million rather than the $100 million maximum, since the updated test did not fully meet the study’s highest performance thresholds.
“These results strengthen our confidence in the role blood-based colorectal cancer screening can play in expanding screening,” Jake Orville, senior VP of Abbott’s cancer diagnostics business, said in a statement. “Combined with Abbott’s preferred, guideline-supported screening option, we’re uniquely positioned to offer healthcare providers and patients a differentiated colorectal cancer screening portfolio built on innovation, performance and choice.”
Freenome, which is privately held, is planning to go public through a merger with Perceptive Capital Solutions, a special-purpose acquisition company (SPAC); a shareholder vote on that deal has been postponed to July 15 from July 9, according to Mikson.