Quantitative Micro-Elastography Imaging System Earns FDA Breakthrough Device Designation for Use in Breast-Conserving Surgery

An optical coherence tomography–based imaging system was granted breakthrough device designation for detection of residual tissue during certain surgical procedures in patients with breast cancer.

Breakthrough device designation has been granted to OncoRes Medical for the expedited development of its Quantitative Micro-Elastography (QME) Imaging System, which is intended to provide surgeons with real-time assessment of breast tumors during surgery.1

The approach offers the opportunity to potentially improve outcomes of breast-conserving procedures and reduce repetitive operations by assisting surgeons to accurately identify cancerous tissues.

“The Breakthrough Device designation highlights the potential of our QME technology to improve and even save lives by addressing a significant clinical issue,” Katharine Giles, MBBS, MBA, CEO, of OncoRes Medical, said in a press release. “It will enable us to pursue a more efficient regulatory and reimbursement pathway in the US, ensuring that surgeons and patients have access to the clinical and potential economic benefits of this technology as soon as possible.”

The QME system was developed to help physicians deal with the re-excisions in breast cancer treatment, which can occur in up to 35% of cases after breast-conserving procedures. Repeated procedures to manage residual tissue can lead to patient anxiety, high complication rates, poor cosmetic outcomes, delays in treatment, and added economic burden.

A 2020 study published in Cancer Research showed that the technology resulted in a 92.9% sensitivity and 96.4% specificity rate versus optical coherence tomography alone at 69.0% and 79.0%, respectively. The quantitative nature of QME helped the investigators develop an automated reader feature that brought sensitivity and specificity rates to 100.0% and 97.7%, respectively.2

For these tests, breast tumor samples were taken from 83 patients undergoing breast-conserving surgery and 7 patients with mastectomies. Of those, 12 and 7 served as controls to build a set of images for reader training, respectively. The remaining 71 patients were included in the blinded reader portion of the study, which yielded to sensitivity and specificity data. Taken together, these results demonstrate high accuracy of QME for detecting tumors within 1 mm of the margin.

Optical coherence technology, an optical technique for rendering 3-dimensional imaging without the use of exogenous contrast agents, served as the underlying mechanism for QME imaging. Preliminary data of QME has demonstrated its superiority to optical coherence technology alone in detecting elasticity and providing contrast between tumor and healthy tissue.

“The ability to detect residual cancer in the cavity at the time of surgery will be game-changing for both breast cancer patients and surgeons,” Christobel Saunders, AO, MBBS, FRCS, FRACS, FAAHMS, OncoRes Medical Chief and professor of surgical oncology at the University of Western Australia, said in a press release. “Surgeons will have greater control over the outcome of the procedure, while patients will have the peace of mind that comes from getting the first step of their breast cancer treatment right on the first try.”

Currently, there are no available intraoperative tools that allow surgeons to perform real-time, in-cavity imaging during breast-conserving surgery. The technology does not require the use of dyes, ionizing radiation, or additional procedures before or after surgery.

Although the technology is being developed for the detection of residual tumor tissue in the breast cancer setting, OncoRes anticipates this to be the first of many clinical indications pursued with the potential for future indications across solid tumor types.


1. OncoRes Medical's Imaging System for Breast Cancer Surgery Gains FDA Breakthrough Device Designation. News release. OncoRes. May 5, 2021. Accessed May 5, 2021. https://bit.ly/3b1vcug

2. Kennedy KM, Zilkens R, Allen WM, et al. Diagnostic Accuracy of Quantitative Micro-Elastography for Margin Assessment in Breast-Conserving Surgery. Cancer Res. 2020;80(8):1773-1783. doi: 10.1158/0008-5472.CAN-19-1240