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Cancer Type
Colorectal cancer (CRC)
Technology Used
IHC
Turnaround Time
2-4 days
Use
HER2 is a known negative predictive biomarker in colorectal cancer (CRC). Recent trials have established HER2 as a therapeutic target in CRC. This assay assists in determining eligibility for HER2 therapy in patients with CRC.
Special Instructions
Testing will be delayed if the pathology report is not received. Fixation time and fixative used must be indicated on the test requisition form.
Limitations
Use of fixatives other than 10% formalin may not yield reliable results.
Methodology
Immunohistochemistry (IHC)
References
Cercek A, Ng K, Strickler JH, et al. HER2 testing in colorectal cancer: concordance analysis between breast and gastric scoring algorithms from the MOUNTAINEER trial. J Clin Oncol. 2023 Feb 1;41:4_suppl, 198-198. doi: 10.1200/JCO.2023.41.4_suppl.198
Djaballah SA, Daniel F, Milani A, Ricagno G, Lonardi S. HER2 in colorectal cancer: the long and winding road From negative predictive factor to positive actionable target. Am Soc Clin Oncol Educ Book. 2022 Apr;42:1-14. PubMed 35580290
Specimen Requirements
Information on collection, storage, and volume
Specimen
Formalin fixed paraffin-embedded (FFPE) tissue block or slides
Volume
One paraffin block or seven unstained, positively charged tissue slides cut at 4-5 microns
Minimum Volume
Five unstained slides
Container
Paraffin block transport pouch or slide mailer
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Tumor type other than colorectal cancer (CRC); fixative other than neutral buffered formalin; insufficient tumor cellularity.
Collection
Specimen should be fixed in a 10% neutral-buffered formalin. Cold ischemic time should be less than one hour and fixation time should be between six and 72 hours.
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