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A New Standard of Reproducibility for Quantitative Biomarkers in Breast Imaging

QTI
  • QT Imaging Holdings reported a multi-site study demonstrating high reproducibility for quantitative biomarkers generated by its Breast Acoustic CT scanner platform.
  • Speed of Sound (SoS) measurements showed variability of less than 1% both within a single scanner & across different scanners.
  • Volumetric measurements derived from SoS data exhibited variability of approximately 5% for Total Breast Volume (TBV) & 12% for the fibroglandular volume to total breast volume ratio (FGV/TBV).
  • The analysis was conducted at two clinical sites with five patients per site, where each patient underwent five scans to characterize within-scanner & across-scanner variability.
  • These results contrast with published benchmarks for breast MRI biomarkers, which report repeatability coefficients of 13% to 15% for apparent diffusion coefficient (ADC) & test-retest variability ranging from 11% to 22% for other metrics.
  • CEO Raluca Dinu stated that the low variability levels support the platform's operator-independent approach & enable objective, data-driven longitudinal monitoring.
  • The findings are based on internal testing & have not yet been reviewed by the U.S. Food & Drug Administration (FDA).
  • QT Imaging is using these metrics to establish a foundation for precision breast health through consistent, quantitative imaging assessments.