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Martell Diagnostic Laboratories, Inc.

2499 Rice St.

Suite 90

Roseville, MN 55113

(651) 927-7973

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FREQUENTLY ASKED QUESTIONS

How is HERTEST different from what I am currently doing?

Tissue tests (IHC or FISH) are generally performed only on the original tumor and are not practical for routine monitoring of metastatic breast cancer patients. Unlike other blood marker tests, such as CA 15-3 and CEA, monitoring with HERTEST provides medical oncologists with specific real time information regarding their patient’s HER2 status. Is the currently administered drug targeting HER2 effective? Is the patient’s HER2 tumor returning? Has the patient’s HER2 negative status changed?

What are HERTEST’s indications for use?

HERTEST is indicated for any positive breast biopsy, providing a baseline serum HER2 value at the time of initial diagnosis. Follow-up HERTEST monitoring is recommended at regular or infrequent intervals, depending on the patient’s initial HER2 tumor status and their baseline serum HER2 level. A detailed testing algorithm is described further on the previous page.

What is a "normal" serum HER2 level?

Extensive testing of normal patient serum with HERTEST indicates that a score of <13.3 ng/ml is normal while an elevated serum HER2 concentration is 13.3 ng/ml or greater.

I have already started treatment. Should I still have my serum HER2 level tested?

Your doctor can use HERTEST to monitor your disease even if you have started treatment.

If I was once HER2 negative, can I now be HER2 positive?

Yes. Even if your first breast cancer tumor was HER2 negative, you can become HER2 positive if your cancer spreads. Serum HER2 levels can become elevated in patients whose initial serum HER2 value is <13.3 ng/mL. This may indicate a change in HER2 status.

Where is the data that supports HERTEST? 

Evidence-based medicine is vital to an oncologist, with data that has been scrutinized by academia key to a test’s adoption. There are more than 100 peer-reviewed articles documenting the importance of serum HER2 monitoring in the clinic, supporting HERTEST as a valuable tool in breast cancer treatment and management.

Where do I get HERTEST?

Ask your doctor about HERTEST.

Who pays for HERTEST?

The American Medical Association (AMA) has approved a unique Current Procedural Terminology (CPT) code for serum HER2 testing. The CPT code is 83950. The Center for Medicaid and Medicare Services (CMS) has additionally established reimbursement for the test. Martell Diagnostic Laboratories directly bills the hospital or clinic, allowing further pricing negotiations with private insurers.