New Reproducibility Standard Set for Breast Imaging Biomarkers
QT Imaging Holdings, Inc., a medical device company focused on advancing breast health through radiation-free imaging technology, has reported new data characterizing the repeatability and reproducibility of quantitative imaging biomarkers generated by its QT Imaging Breast Acoustic CT Scanner platform. The company said the findings reinforce the consistency of its imaging technology and support its long-term goal of helping establish a more objective, data-driven approach to breast health assessment.
The results are particularly relevant as healthcare systems, clinicians, and researchers increasingly look to quantitative imaging biomarkers as tools to monitor disease, assess treatment response, and guide clinical decision-making over time. In this context, reproducibility is a critical requirement. If a biomarker is to be used for longitudinal monitoring or precision medicine, clinicians must be confident that changes seen from one scan to another represent a true biological shift rather than normal variation in the measurement process.
According to QT Imaging, the new study demonstrated high reproducibility across multiple biomarkers produced by the company’s imaging platform. The strongest results were seen in Speed of Sound (SoS), a core tissue property measured directly by the scanner, which showed variability of less than 1% both within a single scanner and across multiple scanners. The company also reported reproducibility data for volumetric measurements derived from SoS image volumes, with Total Breast Volume (TBV) showing variability of about 5% and the ratio of fibroglandular volume to total breast volume (FGV/TBV) showing variability of roughly 12%.
Taken together, the findings are intended to show that the platform can deliver quantitative measurements with a high degree of consistency, even when scans are performed across different systems and clinical settings. That consistency is especially important in breast imaging, where physicians increasingly want tools that can move beyond subjective visual interpretation and toward more precise numerical metrics that can be tracked over time.
Study Designed to Measure Both Repeatability and Reproducibility
The repeatability and reproducibility assessment was conducted at two clinical sites, with five patients enrolled at each site. Each patient underwent five scans per site, allowing the company to evaluate measurement variability both within a single scanner and across different scanners. This design enabled QT Imaging to examine how reliably its biomarkers perform under repeated imaging conditions and in different clinical environments.
Such studies are important because the value of any quantitative imaging biomarker depends not only on its biological relevance but also on its technical reliability. If a biomarker produces meaningfully different values when the same patient is scanned multiple times under similar conditions, it becomes difficult to know whether observed changes reflect actual disease progression, treatment effect, or simply measurement noise.
QT Imaging’s results suggest that its platform may be able to reduce that uncertainty. The company said the low variability observed for SoS, in particular, provides confidence that changes in this measurement over time are more likely to represent real tissue differences rather than inconsistency in the imaging system itself. This is a crucial point for any imaging technology that hopes to support longitudinal follow-up, therapeutic monitoring, or early detection of subtle tissue changes.
Why Reproducibility Matters in Quantitative Breast Imaging
The growing emphasis on reproducibility reflects a broader shift taking place across medical imaging. Historically, much of breast imaging has relied on radiologists’ interpretation of visual patterns seen on mammography, ultrasound, or MRI. While these methods remain foundational, the field is increasingly moving toward the use of quantitative biomarkers—numerical values derived from imaging that can provide more objective and standardized information about tissue characteristics.
These biomarkers may eventually play a role in a wide range of clinical applications, from identifying suspicious changes in tissue composition to tracking treatment response in patients undergoing therapy. In order for those measurements to be trusted and integrated into clinical practice, however, they must be reproducible across repeated scans, across different imaging systems, and ideally across multiple clinical sites.
That requirement is particularly relevant in breast imaging, where subtle differences in tissue density, structure, or composition can carry important clinical implications. A biomarker that fluctuates widely due to scanner variability or operator technique would have limited clinical usefulness. By contrast, a biomarker with low variability can potentially provide a more stable and reliable basis for comparing scans over time.
QT Imaging argues that its platform is well suited to this need because it is designed to generate operator-independent quantitative data. Rather than relying heavily on image acquisition technique or manual interpretation, the company’s technology is intended to capture objective tissue measurements that can be reproduced consistently in different settings.
Speed of Sound Emerges as a Key Strength of the Platform
Among the metrics reported in the study, Speed of Sound appears to be one of the most important. SoS is described by QT Imaging as a fundamental tissue property that is measured directly by the scanner. In acoustic imaging, the speed at which sound travels through tissue can provide information about the composition and characteristics of that tissue, potentially making it a valuable biomarker in breast health evaluation.
The fact that SoS demonstrated variability of less than 1% both within and across scanners is a notable result, because it suggests a very high degree of technical consistency. In practical terms, that means repeated SoS measurements are unlikely to shift significantly unless there is a real change in the underlying tissue. For clinicians and researchers interested in monitoring tissue changes over time, that level of repeatability could be especially meaningful.
The company also assessed volumetric biomarkers derived from SoS image volumes. Total Breast Volume showed variability of around 5%, while FGV/TBV, a ratio intended to reflect the proportion of fibroglandular tissue within the breast, showed variability of approximately 12%. Although these figures are higher than the SoS variability, QT Imaging still presents them as evidence of strong reproducibility for quantitative breast imaging measurements.
Comparison With Published Breast MRI Biomarker Variability
QT Imaging placed its results in context by comparing them with published variability benchmarks for breast MRI quantitative biomarkers. The company cited benchmarks from the Radiological Society of North America’s Quantitative Imaging Biomarkers Alliance (QIBA), which reported repeatability coefficients for breast MRI apparent diffusion coefficient (ADC) measurements in the range of approximately 13% to 15%.
The company also referenced a study by Aliu et al., which reported test-retest variability in normal breast tissue of roughly 11% for ADC, 13% for fibroglandular tissue density, and 22% for fibroglandular tissue enhancement. Against those published figures, QT Imaging’s reported variability range of less than 1% to 12% appears favorable, at least for the biomarkers evaluated in the study.
The comparison is significant because MRI-based quantitative biomarkers are often considered among the more advanced tools in breast imaging research. By showing lower variability in several of its own measurements, QT Imaging is positioning its acoustic imaging platform as a potentially competitive alternative for generating reproducible quantitative breast data.
At the same time, the company’s messaging is not just about outperforming published benchmarks. It is also about highlighting the broader opportunity for radiation-free, quantitative breast imaging that could complement or expand current approaches in breast health management. If the technology continues to generate robust reproducibility data and ultimately demonstrates clinical utility, it could support new ways of monitoring breast tissue over time in a more objective and standardized manner.
Company Sees Results as Foundation for Precision Breast Health
Raluca Dinu, Chief Executive Officer of QT Imaging, said the results reinforce the importance of consistency in quantitative imaging. She noted that imaging biomarkers only become truly useful when they can be measured reliably and repeatedly, and said the variability range reported by QT Imaging demonstrates both the stability of the platform and the benefits of its operator-independent design.
According to Dinu, the company sees this consistency as an important step toward advancing breast imaging beyond traditional qualitative interpretation and toward a model built around objective, reproducible, and data-driven assessment. That vision aligns with a broader trend in medicine toward precision health, where imaging, diagnostics, and treatment monitoring are increasingly guided by quantifiable data rather than solely by visual review or subjective interpretation.
QT Imaging believes that by generating objective measurements that remain stable over time and across different clinical sites, its Breast Acoustic CT platform can help lay the groundwork for the next generation of quantitative breast imaging. Such a shift could eventually influence how clinicians monitor breast tissue changes, assess treatment response, and evaluate risk in a more standardized way.
While the company’s announcement focuses on reproducibility metrics rather than clinical outcomes, the data may still represent an important milestone for QT Imaging’s broader strategy. For emerging imaging technologies, demonstrating repeatability and reproducibility is often one of the first critical steps toward broader clinical adoption, because it establishes confidence in the underlying measurements before larger studies are undertaken to validate clinical utility.
In the case of QT Imaging, the new results support the idea that its acoustic imaging platform can produce stable and reliable quantitative biomarkers across repeated scans and across different scanners. That technical consistency may prove increasingly valuable as healthcare providers seek imaging tools that can support longitudinal monitoring, more precise tissue characterization, and ultimately more personalized breast health management.
As quantitative imaging becomes a larger part of clinical decision-making, the ability to distinguish genuine biological change from simple measurement variability will remain central. QT Imaging is betting that its reproducibility data will help demonstrate that its platform can meet that challenge and contribute to the development of a more objective and precision-focused future for breast health.
About QT Imaging
QT Imaging Holdings, Inc. (Nasdaq: QTI) is a medical device company engaged in the research, development, and commercialization of innovative imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience.
