Frequently Asked Questions for Physicians


What is HERmark?
HERmark is an assay that precisely measures HER2 total protein expression and HER2 homodimers for 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.
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How do I order the test?
Call Monogram Oncology services (1-800-777-0177) 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.
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How does the HERmark test work?
The HERmark breast cancer assay is based on VeraTag™ technology. HERmark quantitatively measures HER2 total protein and functional HER2 homodimers 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 photo-activated molecule. The fluorescent tags are then quantified using capillary electrophoresis (CE).
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What is the turnaround time for getting results?
Typically a HERmark breast cancer assay result will be completed and reported back in seven days.
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Is HERmark appropriate for all types of invasive breast cancer?
The HERmark report is based on reference data from 1,090 samples in both adjuvant and metastatic breast cancer patient cohorts. The patient data represent a large sample size and covers a broad range of HER2 protein levels. Therefore, the HERmark Breast Cancer Assay can accurately quantify HER2 total protein expression and HER2 homodimers in most properly formalin-fixed paraffin embedded (FFPE) breast cancer tumor tissue specimens.
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Will my insurance pay for the test?
Monogram Biosciences is working directly with all providers and payers to provide reimbursement as quickly as possible. However, because this technology is so new, many insurance plans are evaluating the assay and have yet to set policy. The company will work with each patient regarding coverage and reimbursement.
For assistance with billing questions contact our Gateway assistance line at 1-877-436-6243.
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Where can I find more clinical data on HERmark?
Data for HERmark has been presented at major Oncology conferences including ASCO and the San Antonio Breast Cancer Symposium. The cohort and study specimens were analyzed in a prospective manner using archived FFPE tissue specimens from the original excisional biopsy. Details on these presentations and our ongoing clinical studies can be found on our website at hermarkassay.com or by calling Monogram's Oncology service line. 1-800-777-0177.
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Does your test help identify patients who should be treated with chemotherapy?
No. HERmark quantifies HER2 total protein levels and HER2 homodimer in patients with breast cancer, the molecular target for trastuzimab therapy.
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Will the test tell me if the patient's cancer will recur?
No, HERmark breast cancer assay does not predict recurrence. HERmark measures HER2 total and HER2 homodimers which are targets for anti-HER2 targeted therapy.
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Does this test report protein expression for more than the HER2 protein?
HERmark measures HER2 total proteins and HER2 homodimers based on the VeraTag technology platform. VeraTag technology can measure other targets including other HER family receptors. Monogram Biosciences currently has HER1 total and HER3 total assays available for research use only.
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How does HERmark define HER2 positive (+)?
A HER2 positive call is made based on comparison with HER2 testing done by reference method testing (central IHC and central in situ hybridization) in 1,090 breast cancer tissue specimens from the Hershey Medical Center/Medical University of Vienna cohort, The Mayo Clinic cohort and the Fin Her Adjuvant Breast Cancer Study. Clinical validation studies are in progress to correlate HERmark measurements with response to HER2 targeted therapies.
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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 email when the report is ready and a downloadable PDF file of the report is provided through a secure web link.
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I need help interpreting the test results. Who can I talk to about the results?
Physicians may call our toll free Monogram Client Services number (1-800-777-0177) to schedule a discussion with our medical affairs group. Based on your specific need, you will be contacted within 24 hours.
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Is the test available outside the US?
o HERmark is not available outside the US at this time.
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How accurate are the results of the HERmark test?
The accuracy for HERmark was determined using known cell line controls covering the entire range of HER2 expression and was compared with ELISA and IHC results in the Clinicical Laboratory Improvement Amendment (CLIA) process.
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The HERmark score is different than my IHC (or FISH) score – how do I know your test is correct?
HERmark objectively quantifies the amount of HER2 receptor protein and functional HER2 homodimers on the cell unlike IHC or FISH. The precision, accuracy, reproducibility, linearity, specificity and sensitivity have been validated across a broad dynamic range of HER2 expression.
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Do you have any ongoing clinical studies?
We are currently recruiting sites for the HERmark Collaborative Biomarker Study. The Collaborative Biomarker Study, pending IRB approval, is a retrospective study that is not designed for treatment intervention. If your healthcare facility is interested in participating they can contact Monogram Biosciences at 1-877-786-5050 or by email at biomarker-studies@monogrambio.com.
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What kind of sample is required for the test?
Adenocarcinoma breast cancer tissue FFPE (formalin fixed paraffin embedded) tissue specimens on five unstained slides or one block is required. Excisional biopsy specimens are preferred; large core biopsies are also acceptable.
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Is the test appropriate for diagnoses of non-invasive carcinoma (i.e. DCIS or LCIS)?
HERmark breast cancer assay has been prospectively analyzed in archived tumor specimens that are invasive carcinoma. There are no data on DCIS or LCIS.
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What types of specimens are not acceptable?
HERmark was validated using tissue samples that were from women with invasive adenocarcinoma breast cancer. All other specimens will be evaluated on a case by case basis.
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What if my institution uses a different fixative (other than formalin) for specimen preparation?
The HERmark breast cancer assay is validated for use on FFPE specimens only.
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How much tissue is required to perform the test?
Monogram Biosciences requires a minimum of five slides with one 5 µm (5 micron) section per positively-charged glass slide. Physicians may submit slides or send the FFPE blocks to Monogram for sectioning. The original blocks are acceptable and will be returned.
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If I submit a tissue block, will the block be returned?
Yes, expect to receive the block in about seven business days.
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How old can the patient sample be in order to get an accurate result?
Tumor tissue sections should be freshly cut and affixed to slides within 4-6 weeks prior to sending to Monogram for testing. All the specimens that Monogram has tested in its clinical validation studies involved archived tissue samples (some up to ten years old). Please contact Monogram Biosciences if you have questions regarding sample preparation and handling at 1-800-777-0177.
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