Ordering Guidance

For gastroesophageal cancer, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual or HERGN / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex.

Shipping Instructions

Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.

Necessary Information

1. An accompanying pathology report stating the final diagnosis is required. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic breast carcinoma.

2. Information regarding fixative used, time to fixation, and duration of fixation as well as tumor type and classification is required.

The following questions, as stated on the Pathology/Cytology Information (T707) form or presented electronically, must be answered:

 a. "Was specimen fixed in 10% neutral buffered formalin within 1 hour from surgical collection time? Yes, No, or Unknown."

 b. "Has specimen been fixed in 10% neutral buffered formalin for 6 to 72 hours? Yes, No, or Unknown."

 c. "Was tissue decalcified? Yes, No or Unknown."

 d. "Tumor type? Primary invasive breast carcinoma or metastatic breast carcinoma."

 e. "Tumor classification? Invasive breast carcinoma, metastatic breast carcinoma, or micro-invasive breast carcinoma."

Specimen Required

Supplies: Pathology Packaging Kit (T554)

Specimen Type:

Preferred: A paraffin-embedded tissue block containing breast cancer tissue that has been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours.

Acceptable: 5 Unstained sections containing breast carcinoma on charged slides cut at 4 microns less than 1 month ago. Tissue on the slides should have been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours.

Container/Tube: Pathology Packaging Kit

Collection Instructions: Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.

Additional Information:

1. According to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, HER2 protein immunohistochemical test results are only valid for nondecalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total time of 6 to 72 hours. Delay to fixation, or under- or over-fixation may affect these results.(1)

2. HER2 immunohistochemistry testing on intracystic papillary carcinoma and solid papillary carcinoma, without clearly stating invasive carcinoma, is not appropriate and will be reported as indeterminate.

3. Paraffin blocks will be returned with final report.