Freenome reported that an updated version of its SimpleScreen CRC blood test met primary and secondary endpoints in a clinical validation study, drawing mixed industry reaction. The analysis used blinded samples drawn from the prospective PREEMPT CRC registry plus previously tested specimens. Across 48,995 asymptomatic, average-risk adults scheduled for colonoscopy across more than 200 sites, the updated test showed overall sensitivity of 80.4% and specificity of 90%. Freenome said sensitivity improved for advanced precancerous lesions and high-grade dysplasia lesions, while overall sensitivity dipped slightly versus the prior version. The company estimated that the update would increase life-years gained and cases of cancer prevented compared with the earlier test iteration, with an additional third version under development that would expand target coverage. For screening operators, even incremental shifts in precancer detection can change the downstream clinical and adoption profile.
Get the Daily Brief