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A New Standard of Reproducibility for Quantitative Biomarkers in Breast Imaging

A New Standard of Reproducibility for Quantitative Biomarkers in Breast Imaging

Multi-site study demonstrates less than 1% variability for Speed of Sound measurements and strong reproducibility across quantitative breast imaging biomarkers

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (Nasdaq: QTI) (“QT Imaging” or the “Company”), a medical device company dedicated to transforming breast health management through innovative, radiation-free imaging technology, today reported the characterization of repeatability and reproducibility metrics for quantitative biomarkers generated by its QT Imaging Breast Acoustic CTTM Scanner platform.

As healthcare increasingly adopts quantitative imaging biomarkers to monitor disease, assess treatment response, and support clinical decision making, reproducibility is essential. Clinicians must be able to distinguish true biological change from measurement variability.

The study demonstrated high reproducibility across multiple QT Imaging biomarkers. Speed of Sound (SoS), a fundamental tissue property measured directly by our scanner, achieved variability (wCV – within subject coefficient of variation) of less than 1% both within a scanner and across scanners. Volumetric measurements derived from SoS image volumes demonstrated variability (wCV) of approximately 5% for Total Breast Volume (TBV) and 12% for the ratio of fibroglandular volume to total breast volume (FGV/TBV). The repeatability and reproducibility analysis was conducted at two clinical sites, with five patients enrolled per site and each patient scanned five times per site, characterizing both within-scanner and across-scanner measurement variability.

This level of reproducibility provides confidence that observed changes in the speed of sound measurements over time will reflect the true differences rather than measurement variability. Such reproducibility is a key prerequisite for the use of quantitative biomarkers in longitudinal monitoring and quantitative assessment over time.

The findings are particularly notable given the variability reported for other quantitative breast imaging biomarkers. Published benchmarks from the RSNA Quantitative Imaging Biomarkers Alliance (QIBA)(1) place the repeatability coefficient for breast MRI apparent diffusion coefficient (ADC) measurements in the range of approximately 13% to 15%. Similarly, Aliu et al.(2) reported test-retest variability (wCV) of approximately 11% for ADC, 13% for fibroglandular tissue density, and 22% for fibroglandular tissue enhancement in normal breast tissue.

In contrast to published breast MRI biomarker variability of approximately 11% to 22%, QT Imaging demonstrated variability ranging from less than 1% to 12% across multiple quantitative biomarkers.

“Quantitative imaging biomarkers are only valuable if they can be measured consistently and reliably,” said Raluca Dinu, Chief Executive Officer of QT Imaging. “Achieving variability levels ranging from less than 1% to 12% across our quantitative biomarkers demonstrates the stability of our platform and the advantages of its operator-independent approach. This level of consistency supports our vision of advancing breast imaging toward objective, reproducible, and data-driven assessment.”

By providing objective measurements that remain consistent over time and across clinical sites, QT Imaging is helping establish the foundation for quantitative breast imaging, and the next generation of precision breast health.

(1) The QIBA Profile for Diffusion-Weighted MRI: Apparent Diffusion Coefficient as a Quantitative Imaging Biomarker, Radiology 2024; 313(1):e233055
(2) Repeatability of Quantitative MRI Measurements in Normal Breast Tissue, Translational Oncology, 2014; 7(1):130 to 137. DOI: 10.1593/tlo.13841

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. For more information on QT Imaging Holdings, Inc., please visit the Company’s website at www.qtimaging.com and follow us on LinkedIn.

Breast Acoustic CT™ is a trademark of an affiliate of QT Imaging Holdings, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the repeatability and reproducibility metrics for quantitative biomarkers generated by the QT Imaging Breast Acoustic CT Scanner, and what that means for its commercialization, advanced image reconstruction software performance of software enhancements, plans for QT Imaging, new product development and introduction, product sales growth and projected revenues, QT Imaging’s industry, future events, and other statements that are not historical facts. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of QT Imaging’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by you or any other investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control. These forward-looking statements are subject to a number of risks and uncertainties, including those relating to: the ability of the Company to sell and deploy the QT Imaging Breast Acoustic CT™ Scanner; the ability to extend product offerings into new areas or products; the ability to commercialize technology; unexpected occurrences that deter the full documentation and “bring to market” plan for products; trends and fluctuations in the industry; changes in demand and purchasing volume of customers; unpredictability of suppliers; the ability to attract and retain qualified personnel and the ability to move product sales to production levels; changes in domestic and foreign business, market, financial, political, and legal conditions; the uncertainty of projected financial information; delays caused by factors outside of our control; changes in our ability to successfully receive purchase orders and generate revenue under our existing contracts with partners and distributors; our ability to realize the benefits of the strategic partnerships; the identified material weakness in our internal controls over financial reporting (including the timeline to remediate the material weakness); the rollout of the business and the timing of expected business milestones; the effects of competition on our future business; our ability to obtain and access financing in the future; our ability to pay our debt obligations as they come due; and those factors discussed in the Company’s reports and other documents filed with the SEC, including under the heading “Risk Factors.” If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that QT Imaging presently does not know or that QT Imaging currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect QT Imaging’s expectations, plans or forecasts of future events and views as of the date of this release. QT Imaging anticipates that subsequent events and developments will cause QT Imaging’s assessments to change. However, while QT Imaging may elect to update these forward-looking statements at some point in the future, QT Imaging specifically disclaims any obligation to do so. Accordingly, undue reliance should not be placed upon the forward-looking statements.

The findings described herein are based on internal testing and analyses and have not been reviewed by the U.S. Food and Drug Administration. These findings do not represent new FDA clearances, approvals, or indications for use.

Investors
CORE IR
Tirth Patel
[email protected]

Media
CORE PR
Matthew Cossel
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KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Technology Research Medical Devices Health Technology Biotechnology Hardware Health Science Oncology

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