Inclusion Criteria:

- Pre-operatively established diagnosis of invasive carcinoma of the breast

- Scheduled for axillary sentinel lymph node dissection as per standard of care at the
clinical site for newly diagnosed breast cancer patients

- Patients for whom the GeneSearch™ BLN Assay will be used intra-operatively to make a
decision for an axillary lymph node dissection

- 18 years of age or older

- Female or male

- Willing and able to give informed consent to participate in the study

Exclusion Criteria:

- Previous diagnosis of lymphoma

- Subjects participating in other research studies that would interfere with their full
participation in this study

- Patients and/or conditions with 'interfering substances' as listed in the IFU.

- Patients who have had any pre-operative treatment for breast cancer including
neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen