SAN ANTONIO, Dec. 8, 2017 /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 clinical data from their clinical study demonstrating that its Imagio™ breast imaging system achieved significant differentiation among prognostic subtypes of breast cancer (PSBC). These prognostic subtypes provide important information about the genes that each patient's cancer expresses. The data are being presented today at 5:00 p.m. during a poster presentation [#P5-02-04] at the San Antonio Breast Cancer Symposium taking place December 5 – 9.
"Confirming a diagnosis of breast cancer is just the first step in understanding the pathology of a patient's tumor," said study presenter Stephen Grobmyer, M.D., Director, Breast Surgical Oncology, Cleveland Clinic. "Determining a patient's prognostic subtype of breast cancer is essential for understanding how tumors will respond to specific therapies and selecting a treatment regimen that offers the patient the best chance of a positive outcome. The findings that OA/US may differentiate among several breast cancer subtypes suggest that this novel imaging methodology could potentially provide a non-invasive alternative to biopsy without sacrificing information about the molecular pathology of the tumor. This could be an important advance for women with breast cancer."
The prospective, multi-center study was conducted at 16 centers in the United States. A total of 1,808 breast masses in 1,739 subjects assessed as BI-RADS (Breast Imaging and Reporting Data System, or BR) category 3, 4 or 5 were imaged with OA/US, resulting in the identification of 678 malignant lesions. Eight blinded readers scored these 678 lesions based on three internal features of the tumor and two external features of the tumor boundary and surrounding tissue. An experienced central breast pathologist who was blinded to the OA/US assessment confirmed the pathologic diagnoses. Biopsy specimens were obtained and assessed for the expression of four genes that comprise the PSBC: estrogen receptor (ER), progesterone receptor (PR), HER2-neu (HER2) and Ki-67. The PSBCs are defined as follows:
Luminal A (LUM-A): ER/PR (+) and Ki-67 and HER2 (-). These tumors are often low grade, with slow tumor growth and are associated with the most positive prognosis.
Luminal B (LUM-B): ER (+), PR (+/-), Ki-67 (+) and HER2 (+/-). These tumors are also low grade but grow more quickly than LUM-A.
