Imagion Biosystems Limited Reports Positive Clinical Data At Breast Cancer Symposium
needed to broaden the study population to fully characterize the diagnostic performance of the imaging agent. Several important findings have emerged from the results to date: · changes in MR contrast created by the specific binding of the MagSense imaging agent to tumour cells in the nodes aids in resolving nodal status; the imaging agent is detectable by magnetic relaxometry, however more subject samples are needed due to the limited amount of accessible dissected nodal tissue to-date; and there have been no safety, toxicity or adverse events reported related to the imaging agent. Breast cancer is one of the most commonly diagnosed cancers among women and is the second leading cause of cancer deaths among women overall. Of the four breast cancer subtypes, HER2 represents 10-20 percent and has significant prognostic and predictive implications because the HER2 subtype is considered an aggressive phenotype with a high rate of recurrence and metastasis. The HER2 status is frequently maintained during progression to invasive disease, nodal metastasis, and distant metastasis. Nodal status often determines the course of treatment including systemic therapy, the extent of surgery, reconstruction options, and the need for radiation therapy after mastectomy. Currently, nodal assessment is based on palpation or conventional imaging techniques, predominantly ultrasound. These methods try to identify nodes that appear to be abnormal by size or shape but are not able to confirm if cancer is present. Therefore, the current standard of care still relies on invasive biopsies and follow up by a pathological confirmation to inform clinical decision making. Imagion's noninvasive and molecularly specific approach to cancer detection has the potential to improve the overall diagnostic accuracy of axillary nodal imaging and reduce the need for invasive biopsies.