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- HER-2 Total
Quantitative determination of HER-2 total protein.
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.
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.
Invasive breast carcinoma, FFPE (formalin-fixed paraffin-embedded) tissue specimens (excisional biopsy specimens preferred). Large core biopsies are also acceptable.
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.
10 mm² of invasive breast cancer per slide.
Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 48 hours.
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
Please attach pathology report. Confirm that all specimens are labeled. Direct any questions regarding this test to Monogram client services at 800-777-0177.