HERmark® Breast Cancer Assay

CPT: 84999
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Test Details

Synonyms

  • HER-2 Total

Use

Quantitative determination of HER-2 total protein.

Limitations

Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield reliable results.

Results of the HERmark® assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, nodal status, patient's age, hormone receptor status, and other known risk factors.

Methodology

VeraTag® technology. Specimens referred to Monogram Biosciences for testing, reporting, and billing. VeraTag® is a registered trademark of Monogram Biosciences Inc, South San Francisco, Calif.

Specimen Requirements

Specimen

Invasive breast carcinoma, FFPE (formalin-fixed paraffin-embedded) tissue specimens (excisional biopsy specimens preferred). Large core biopsies are also acceptable.

Volume

Four slides: 5-μM sections on glass slides (A total of four unstained slides per patient are required; freshly cut sections should be sent within one week.) or one paraffin-embedded tissue block. If multiple blocks are available, select the tissue block with the highest amount of viable invasive tumor; submit only one block.

Minimum Volume

10 mm² of invasive breast cancer per slide.

Container

Paraffin block transport pouch or slide mailer.

Collection

Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 48 hours.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Fixative other than neutral-buffered formalin; insufficient tumor specimen; tumor types other than breast (Note: Metastatic biopsies of primary breast origin are acceptable.); only DCIS and LCIS cases

Clinical Information

Special Instructions

Please attach pathology report. Confirm that all specimens are labeled. Direct any questions regarding this test to Monogram client services at 800-777-0177.

References

Duchnowska R, Biernat W, Szostakiewicz B, et al. Correlation between quantitative HER-2 protein expression and risk for brain metastases in HER-2+ advanced breast cancer patients receiving trastuzumab-containing therapy. Oncologist. 2012; 17(1): 26-35. 22234627
Huang W, Reinholz M, Weidler J, et al. Comparison of central HER2 testing with quantitative total HER2 expression and HER2 homodimer measurements using a novel proximity-based assay. Am J Clin Pathol. 2010 Aug; 134(2): 303-311. 20660336
Joensuu H, Weidler J, Lie Y, et al. Quantitative measurements of HER2 expression and HER2 homodimers using a novel proximity-based assay: Comparison with HER2 status by immunohistochemistry and chromogenic in situ hybridization in the FinHer study. San Antonio Breast Cancer Symposium, 2008. Poster N° 2071.
Larson JS, Goodman LJ, Tan Y, et al. Analytical validation of a highly quantitative, sensitive, accurate, and reproducible assay (HERmark) for the measurement of HER2 total protein and HER2 homodimers in FFPE breast cancer tumor specimens. Patholog Res Int. 2010 Jun 28; 814176. 21151530
Lipton A, Köstler WJ, Leitzel K, et al. Quantitative HER2 protein levels predict outcome in fluorescence in situ hybridization-positive patients with metastatic breast cancer treated with trastuzumab. Cancer. 2010 Nov 15;116(22): 5168-5178. 20661914
Shi Y, Huang W, Tan Y, et al. A novel proximity assay for the detection of proteins and protein complexes: quantitation of HER1 and HER2 total protein expression and homodimerization in formalin-fixed, paraffin-embedded cell lines and breast cancer tissue. Diagn Mol Pathol. 2009 Mar; 18(1): 22-29. 19214113

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf