This test is only orderable by Surgical Pathology and is intended for the following uses:

1. Aid in prediction of response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma
2. Confirmation of equivocal HercepTest (2+) immunohistochemistry (IHC) result

• Average TAT: 5 days

1. Formalin Fix the specimen by submerging the Tissue in 10% Neutral Buffered Formalin
2. Send the Formalin-Fixed Tissue to the Anatomic Pathology Lab
3. The Anatomic Pathology Lab will paraffin-embed the tissue and prepare a Tissue Block
4. The Tissue block will be sent to the Cytogenetics Laboratory for testing

1. Formalin Container

2. Non-Sterile Liquid-Proof Container

• Medium to large specimens for routine processing that do not fit in prefilled formalin containers can be can be sent in specimen containers without formalin
• Anatomic Pathology staff will add formalin when the specimen is received in the lab

Unacceptable Conditions:
Specimens are considered unacceptable and will be rejected if the following conditions apply:

1. Specimens that have been frozen
2. Specimens that have been preserved in fixatives other than formalin
3. Specimens that have been preserved in heavy metal fixatives (B-4 or B-5)
4. Specimens without any tumor present in tissue
5. Specimens that have been decalcified
6. Unlabeled or mislabeled specimens

Suboptimal Conditions:
Culture and analysis will be attempted on specimens received under the following conditions, but results may be suboptimal:

1. Specimens that have been improperly collected, stored, or transported (unless listed above)
2. Specimens with insufficient volume for testing

• Fixed Specimens: Room Temperature
• Fresh Specimens: Refrigerated

• Room Temperature: 1 week
• Refrigerated: Not recommended
• Frozen: Unacceptable

• Room Temperature: 3 hours
• Refrigerated: 24 hours
• Frozen: Unacceptable

• Room Temperature: Indefinitely
• Refrigerated: Indefinitely
• Frozen: Unacceptable

• Fixed Specimens: Room Temperature
• Fresh Specimens: Refrigerated
• FFPE Tissue Blocks/Slides: Room Temperature

• Tissue Slides: 6 months

1. Collect Tissue specimen and place into a Sterile Container with enough 10% formalin to cover the tissue by at least 2 - 3 inches.

• Breast Specimens: Immerse in fixative within 1 hour of biopsy or resection procedure for optimum tissue processing. Document the time that the tissue was placed into formalin.
• Suspicion of Lymphoma: Send FRESH. Do NOT place specimen into formalin.

2. Specimens should be delivered to the Surgical Pathology Lab as soon as possible.  If delivery of a resection specimen to the Surgical Pathology department is delayed (e.g. specimens from remote sites), the tumor should be bisected prior to immersion in fixative.

• It is important that the surgeon ensure that the identity of the resection margins is retained in the bisected specimen
• Alternatively, the margins may be separately submitted

3. Ensure that the cap is tightly secured on the Collection Container
4. The time of removal of the tissue and the time of immersion of the tissue in fixative should be recorded and submitted to the laboratory

1. Collect tissue specimen and place in large leak-proof container
2. Bring specimen to the Surgical Pathology laboratory immediately, or refrigerate

1. Specimen Containers submitted to Surgical Pathology must be labeled with the following patient information:

• First and Last Name
• Date of Birth
• Medical Record Number
• CSN Number
• Name of Specimen Site/Source

2. Check all labeling of containers prior to leaving the collection site

3. Place the following in a biohazard bag for transport to the Surgical Pathology Lab:

• Specimen Containers
• Specimen Requisitions

Processing Instructions (Surgical Pathology Laboratory):

1. Formalin Fix fresh tissues in 10% Neutral Buffered Formalin
   • Specimen must be placed in 10% neutral buffered formalin within an hour of collection (Cold Ischemia Time (CIT)) and fixed for a total of 6 to 72 hours prior to histology processing
2. Paraffin-embed the fixed tissue and prepare FFPE Tissue Block

1. Prepare the following by cutting 5 micron sections from the FFPE tissue and mounting on positively charged glass slides:
   • 4 unstained slides with 5 micron sections

     
     AND

   • 1 H&E stained slide with a 5 micron section. Circle the area of interest.
     
     
2. Place slides into a protective container, protect the slides from excessive heat, and transport to the Cytogenetics Laboratory for testing

         

3. Include the Surgical Pathology report with the specimen

*Refer to report for result specific interpretation details.

UCSD uses the most recent ASCO/CAP interpretation criteria for evaluating ERBB2 (HER2) status.