GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study
GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study
The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test
 Kit to permanent pathological section, so as to evaluate the clinical sensitivity and
 specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel
 lymph node metastases in breast cancer patients.

 The secondary objective of this trial is to evaluate the positive predictive value and
 negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the
 detection of axillary sentinel lymph node metastases in breast cancer patients.

 Prospective and multi-center clinical trial
Inclusion Criteria:

 -  Diagnosed previously as breast cancer

 -  patient scheduled for sentinel lymph node dissection

 -  18 years or older

 -  female or male, and

 -  able and willing to give consent to participate in the study

 Exclusion Criteria:

 -  Patients taking part in other research studies that would interfere with their full
 participation in this study, or

 -  Prior sentinel or partial axillary lymphadenectomy on the same body side