New Data Demonstrate That Seno Medical’s Opto-Acoustic Imaging Technology Offers A Non-Invasive Approach to Differentiating Breast Cancer Molecular Subtypes

–  Company’s technology, which shows promise as a clinical prognostic tool that may facilitate treatment decisions, featured as a High Impact Clinical Trial at the Radiological Society of North America Annual Meeting for second year in a row –

SAN ANTONIO, Dec. 11, 2018 /PRNewswire/ — Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic (OA/US) imaging to differentiate benign from malignant masses, reported results of a study demonstrating that morphologic and functional OA/US features provide a non-invasive approach to helping distinguish breast cancer molecular subtypes. The data were presented on November 26, 2018 at the Radiological Society of North America (RSNA) 2018 Annual Meeting in Chicago and the abstract was featured as one of three High Impact Clinical Trials selected for this special session.

“It has been known for some time that breast cancers with differing receptor expression and gene amplification profiles have different risk factors for disease progression, as well as different preferential organ sites of metastases and therapeutic response. Nevertheless, large-scale gene expression profiling from biopsy samples is not currently feasible,” said Thomas Stavros, MD, Chief Medical Officer of Seno Medical. “We previously hypothesized that more aggressive molecular subtypes might be detectable based on their OA/US feature scores. The results of intense comparison of our histological and OA/US imaging demonstrate and underscore the potential value of OA/US as a novel and non-invasive tool for gleaning critical information that may help to guide and optimize treatment for women with breast cancer. The importance of these data is underscored by their inclusion in the High Impact Clinical Trial category, and we are pleased that RSNA selected our OA/US technology for this honor for the second year in a row.”

There are four distinct main molecular subtypes of breast cancer, which are defined based on the presence of hormone receptors (estrogen [ER] and progesterone [PR]) with or without human epidermal growth factor receptor 2 (HER2) protein overexpression or extra copies of the HER2 gene, and elevation of the ki67 proliferation marker. The four subtypes are:

• Luminal A (LumA; ER+/HER2−negative, ki67<14%);
• Luminal B (LumB; ER+/HER2-negative, ki67≥14%, or ER+/HER2+);
• HER-2 amplified or positive (HER2+; ER-negative, HER2+) and
• Triple Negative Breast Cancer (TNBC); ER and PR-negative/HER2−negative).

The study investigated the potential role of functional OA/US imaging-derived hemoglobin de-oxygenation and angiogenesis feature scoring combined with conventional gray-scale ultrasound (US) in non-invasively diagnosing these breast subtypes.¹ A total of 2,105 women with suspicious breast masses who underwent pre-biopsy OA/US imaging using Seno’s Imagio® OA/US Breast Imaging System at 16 clinical sites between December 2012 and September 2015 were included in the study. Lesions revealing invasive breast cancer on needle biopsy were retrospectively reviewed, and seven blind readers scored the internal (OAINT) and external (OAEXT) OA/US features of identified cancers. The ratio of total internal to total external US and OA/US feature scores (RInt/Ext) was derived. Tumor hormone receptor (ER and PR), and HER2 status, and available ki67(%) labeling index were derived from pathology specimens. Key findings from the study include:

• Of 653 invasive cancers, 537 (82.2%) were ER+ and 111 (17%) were ER-negative, with ER data missing for 5 (0.8%) patients.
  ER+ cancers had significantly higher OAEXT (p<0.001), with lower OAINT (p<0.05) and RInt/Ext (p<0.001) compared with ER-negative ones.
• Of 532 patients with available pathologic molecular subtype, 186 (35.0%) were LumA, 244 (45.9%) were LumB, 79 (14.8%) were TNBC and 23 (4.3%) were HER2+.
• All OAEXT scores were lower in TNBC compared with LumA (p<0.001), whereas OAINT vessels and total scores were lower in LumA compared with TNBC (p<0.05).
• The mean RInt/Ext was significantly higher in TNBC (1.7, SD ± 0.7) compared with LumB (1.3, SD ±0.5) and LumA (1.2, SD ± 0.5) subtypes (p<0.001), but not significantly different from HER2 (1.5, SD ±0.6).
• RInt/Ext feature scores helped distinguish LumA vs. LumB (p<0.05), LumA vs. HER2+ (p<0.05, LumA vs. TNBC (p<0.001) and LumB vs. TNBC (p<0.001).
• The data demonstrate that morphologic and functional OA/US features may provide a non-invasive approach to help distinguishing breast cancer molecular subtypes. The study authors conclude that data from such subtype analyses could potentially facilitate clinical management decisions.

“The exciting finding in this study is OA/US imaging features may serve as imaging biomarkers that predict molecular phenotypes. This not only helps establish the diagnosis of breast cancer, but also distinguishes cancers with poor prognosis from those with good prognosis non-invasively – using no radiation, contrast or a need for biopsy,” said Basak E. Dogan, MD, University of Texas Southwestern Medical Center, presenter at RSNA and the first author of the study. “This is an important step forward to non-invasively optimize treatment regimens in keeping with the unique molecular profile of each woman’s cancer. Furthermore, it is a great opportunity to assess the cancer three dimensionally instead of making treatment decisions based on small biopsy samples. OA/US has the potential to improve treatment outcomes for women with invasive breast cancer.”

The Imagio® OA/US Breast Imaging System is the subject of a U.S. PMA filing with the FDA and does have European CE Mark.

About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio® OA/US Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the Imagio OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

1. Moy L, Dogan BE, Menezes GD, Neuschler EI, Butler RS, Stavros AT, et al. Optoacoustic imaging (OA) is helpful in predicting breast cancer molecular subtypes. Presented at RSNA 2018 on November 26. Abstract SPS126B.