Frequently Asked Questions for Patients

What is HERmark?
HERmark is an assay that precisely measures HER2 total protein expression and HER2 homodimers for patients with breast cancer.
Top

Why do I need to know the HER2 status of my tumor?
Studies show that approximately 25% of breast cancer patients have tumors that are HER2 positive (HER2+). HER2 stands for Human Epidermal growth factor Receptor 2. It is very important to find out your cancer's HER2 status. This is because HER2+ tumors tend to grow and spread more quickly than tumors that are not HER2+. In addition, the treatment of HER2+ breast cancer is different than the treatment of breast cancer that is not HER2+.

Women who are uncertain of their cancer's HER2 status should talk to their doctor about the HERmark Breast Cancer Assay.
Top

How does the HERmark test work?
The HERmark breast cancer assay is based on proprietary VeraTag technology which identifies HER2 protein receptors. These receptors are the targets for Hereceptin® therapy. An accurate measure of your HER2 status is provided to your physician in the HERmark report.
Top

Am I eligible for the test if my tissue was extracted several months/years ago?
Tumor tissue sections should be freshly cut and affixed to slides within 4-6 weeks prior to sending to Monogram for testing. There are currently no specific studies that have compared HERmark results from recently fixed paraffin-embedded specimens versus archived tumor specimens (months or years old). However, all the specimens that Monogram has tested in its clinical validation studies involved archived tissue samples, some up to ten years old. Contact Monogram Biosciences if you have any questions regarding specimen preparation or handling at 1-800-777-0177.
Top

How do I get the results of the HERmark test?
Test results are reported to your healthcare provider through an on-line reporting system, fax and by mail.
Top

How do I order the test?
HERmark is ordered through your healthcare provider. The healthcare facility will prepare the tumor sample and send it directly to Monogram Biosciences. If you would like to have a HERmark breast cancer test performed, talk with your healthcare provider.
Top

Will the test tell my doctor what kind of therapy to use?
HERmark will provide your physicians with accurate quantitative results of the amount of HER2 total protein and functional HER2 protein available in the tissue sample.

Your healthcare provider will determine the best therapy available for you.
Top

Will the test tell me if my cancer will recur?
No, HERmark breast cancer assay does not predict recurrence. HERmark measures HER2 total and HER2 functional proteins which are targets for anti-HER2 therapy.
Top

Are there other methods/tests that can tell me the HER2 status?
o In addition to HERmark there are two types of tests that might be used, IHC (immunohistochemistry) and FISH (fluorescence in situ hybridization). Unlike IHC or FISH, HERmark objectively quantifies the amount of HER2 receptor protein and functional HER2 receptor proteins on the tumor cell surface. The report will show these quantities and where your measure is in reference to a large data set of tissue specimens.
Top

Will the test tell me if I should/should not receive chemotherapy?
HERmark can reliably give your healthcare provider a quantifiable measure of HER2 proteins in a tissue sample. This along with other information may assist your clinician in determining the most appropriate therapy.
Top

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 new, many insurance plans are evaluating the assay and have yet to set policy. Monogram will work with each patient regarding coverage and reimbursement.
Top

I need help interpreting the test results. Who can I talk to about the results?
Talk with your physician or licensed healthcare provider about the test results.
Top

My physician is unfamiliar with HERmark - how can I get HERmark?
Only a licensed physician can order the test. Monogram Biosciences is available to your healthcare provider for any questions they may have. Ask your healthcare provider to contact us at 1-800-777-0177 or on the web at hermarkassay.com.
Top

Is the test available outside the US? If so, what is the process for submitting an international sample?
HERmark is not available outside the US at this time.
Top