HERmark® Assay

HERmark® Assay

HERmark® Report

The results of the HERmark® Assay are delivered in a simple report as a quantitative measurement of the patient’s HER-2 total protein level, along with an interpretation of the result.

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HERmark® FAQs

  • What is HERmark?

    HERmark is an assay that precisely measures HER-2 total protein expression in patients with breast cancer. Clinical studies demonstrate that HERmark is an accurate method for stratifying patients with breast cancer who are more likely to respond to trastuzumab-containing therapy.

  • How do I order the test?

    Call Monogram Oncology Services (800-777-0177) to set up an account. Monogram Biosciences will provide a test request form, shipping kit, and instructions on how to send the tissue to the Monogram’s central laboratory in South San Francisco, California.

  • How does the HERmark test work?

    The HERmark breast cancer assay is based on VeraTag® technology. HERmark quantitatively measures HER-2 total protein using a dual antibody format, whereby a fluorescent tag on one analyte-specific antibody is cleaved when in close proximity to a second antibody containing a photoactivated molecule. The fluorescent tags are then quantified using capillary electrophoresis (CE). 

  • Is HERmark appropriate for all types of invasive breast cancer?

    The HERmark report is based on reference data from 1090 samples in both adjuvant and metastatic breast cancer patient cohorts. The patient data represent a large sample size and covers a broad range of HER-2 protein levels. Therefore, the HERmark Breast Cancer Assay can accurately quantify HER-2 total protein expression in most properly formalin-fixed paraffin-embedded (FFPE) breast cancer tumor tissue specimens.

  • Is HERmark covered by insurance?

    HERmark is covered and reimbursed by Medicare. Many other payers are currently reimbursed for the HERmark Breast Cancer Assay. Monogram works directly with providers and payers to gain reimbursement as quickly as possible. In addition, the company will work with each patient regarding coverage and reimbursement if needed. For assistance with billing questions, contact our Gateway assistance line at 877-436-6243.

  • Where can I find more clinical data on HERmark?

    Monogram has published clinical data utilizing HERmark and other VeraTag® assays in multiple peer-reviewed journals. Click here to view our publications.

  • Does this test report protein expression for than the HER-2 protein?

    HERmark measures HER-2 total proteins using the VeraTag®​ technology platform. VeraTag assays for measurement of multiple other protein biomarkers are available for use in preclinical development and clinical trials. Click here to learn more about VeraTag applications

  • How is the test result reported?

    Test results are reported via vLink, Monogram's online reporting system, FedEx®, fax, or mail. With vLink, you will be notified by e-mail when the report is ready, and a downloadable PDF file of the report will be provided through a secure Web link.

  • I need help interpreting the test results. Who can I talk to about the results?

    Physicians may call our toll-free Client Services number (800-777-0177) to schedule a discussion with our Medical Affairs Group. Based on your specific need, you will be contacted within 24 hours.

  • What kind of sample is required for the test?

    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.

  • Is the test appropriate for diagnoses of noninvasie carcinoma (i.e., DCIS or LCIS)?

    The HERmark Breast Cancer Assay has been prospectively analyzed in archived tumor specimens that are invasive carcinoma. There are no data on ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).

  • If I submit a tissue block, will the block be returned?

    Yes, expect to receive the block in about seven business days.

HERmark® versus FISH

HERmark® was shown to outperform fluorescent in situ hybridization (FISH) at determining patient outcomes in patients with metastatic breast cancer treated with trastuzumab. HERmark results correlate highly with trastuzumab outcomes in the Hershey/Vienna Council cohort (n=103).1

HERmark/FISH Discordance

Within the group of patients who were FISH-positive, those with a low HER-2 total had a shorter time to progression (TTP) than those who had a high HER-2 total.

Reclassify HER2 Status

HERmark® enables physicians to classify HER-2 status with a new level of confidence. The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines recommend that HER-2 status be determined for all invasive breast cancer patients. These guidelines caution that current HER-2 testing methods (central immunohistochemistry [IHC] and fluorescent in situ hybridization [FISH]) may be inaccurate in up to 20% of cases.1,2

The HERmark Breast Cancer Assay precisely quantifies HER-2 total protein levels in formalin-fixed paraffin-embedded (FFPE) samples. HERmark reclassified up to 23% of samples from a cohort of the FinHer Adjuvant Breast Cancer Study.3

HER Pathways

HER Pathways

The human epidermal growth factor receptor (HER) family has four receptors: HER-1(EGFR), HER-2, HER-3 and HER-4. These receptors and their associated signaling pathways have been the focus of research and development of targeted therapies. Biologics, such as erlotinib, lapatinib, and trastuzumab, were developed as a result of this research. Many of these targeted therapies use diagnostic tests to identify the best patients for the treatment.

Monogram’s VeraTag® is a proximity-based technology platform designed to detect and quantify proteins and protein-protein complexes, including homodimers and heterodimers of the HER family of cell-surface receptors.