Have you used a home testing kit for a medical diagnosis?

COVID-19 RATs are an example of these types of tests but we are interested in the many others on the market.

The University of Wollongong is conducting a small study about them and we'd like to hear from you if you have used one or considered using one.

Simply complete a short survey at:

From here, we may invite you to take part in a paid interview.

For more information, contact Dr Patti Shih: pshih@uow.edu.au

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At a glance

Also known as

c-erbB-2, HEU2/neu, ERBB2

Why get tested?

To determine whether a breast cancer tumour is positive for HER2/neu, which helps to guide treatment decisions and predict the course of the disease. HER2 testing is used in the assessment of breast cancer and some other tumours, including certain types of stomach and oesophageal cancer.

When to get tested?

If you have been diagnosed with a cancer which may be responsive to treatment with HER2 targeted therapyand your doctor wants to determine whether the HER2/neu gene is being over-expressed in the tumour

Sample required?

A sample of tumour tissue obtained during a biopsy; sometimes a blood sample, drawn from a vein in your arm, is also required

Confused about genetics?

See our Genetics Information page

What is being tested?

HER2 is an oncogene. It codes for a receptor for a particular growth factor that causes cells to grow. Normal epithelial cells contain two copies of the HER2 gene and produce low levels of the HER2 protein on the surface of their cells. In about 20-30% of invasive breast cancers (and some other cancers, such as certain stomach and oesophageal), the HER2 gene is amplified (far too many copies are produced) and its protein is over-expressed (an abnormally large amount of the protein is produced). Cancers that have this over-expression are known as HER2-positive. HER2-positive tumours tend to grow more aggressively and respond differently to treatment than HER2-negative tumours.

There are two main ways to test HER2 status in cancer tissue: immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH). IHC measures the amount of HER2 protein present. FISH looks at the genetic level for actual gene amplification – the number of copies of the HER2 gene present.

How is the sample collected for testing?

Most HER2 testing involves taking a sample of tumour tissue by doing a fine needle aspiration, needle biopsy or surgical biopsy

Is any test preparation needed to ensure the quality of the sample?

No test preparation is needed.

The Test

How is it used?

HER2 testing is primarily used to determine whether a person with breast cancer (and some other cancers, such as certain stomach and oesophageal cancers) may benefit from HER2-targeted treatment such as Herceptin (trastuzumab). In the past, HER2-positive breast cancers were associated with an increased risk of recurrence and a poorer outcome. However, with the use of targeted treatment against HER2 and chemotherapy, the prognosis of HER2-positive breast cancer has improved substantially.

The serum HER2 test is sometimes used to monitor cancer therapy. If the level is initially elevated then falls, it is likely that treatment is working; if it stays elevated, treatment is not working; and if the level falls then rises, the cancer may be recurring.

When is it requested?

HER2 testing is recommended as part of an initial work-up of invasive breast cancer and is sometimes done with recurrent breast cancer. It is not diagnostic but helps the doctor determine treatment options and understand more about the tumour’s characteristics.

Serum HER2 is sometimes requested initially to establish a baseline and then, if elevated, used to monitor cancer treatment.

What does the test result mean?

A positive HER2 IHC test means that the HER2 gene is over-expressing (producing an excess amount of) HER2 protein. A positive FISH test means that there is an amplification of the HER2 gene (production of too many copies). If either test is positive, the patient is likely to have an aggressive tumour. HER2-positive patients are potential candidates for HER2 trageted therapy such as Herceptin (trastuzumab).[See "Is there anything else I should know?"].

Currently, Herceptin is approved in Australia for the treatment of HER2 positive early stage breast cancer and HER2 positive advanced breast cancer.

Herceptin use has also been approved in Australia for use in advanced cancers of the stomach or lower oesophagus, if they are shown to be HER2 positive and anti-cancer medications have not yet been commenced.

About Reference Intervals

Is there anything else I should know?

HER2-positive tumours may be susceptible to Herceptin (trastuzumab), a therapy created to target HER2 protein. Herceptin, an antibody made in the laboratory, attaches itself to the excess protein molecules and inhibits the growth of the cancer. The development of this specialised therapy has increased the use of HER2 testing. Herceptin may be used alone or with some chemotherapy agents but is only useful in those who have HER2 amplification and protein over-expression.

Tissue HER2 testing is not available in every laboratory. Both IHC and FISH require experience and special training to perform and to interpret.

Herceptin use has also been approved in Australia for use in advanced cancers of the stomach, if they are shown to be HER2 positive.

Common Questions

Besides HER2/neu, what other laboratory tests may my doctor request on my breast cancer tissue?

During an initial workup of invasive breast cancer, your doctor is likely to do a tissue test for hormone receptor status. A patient with a positive oestrogen and/or progesterone receptor status may find their response to endocrine or hormone therapy diminished if they are also HER2-positive.

Does Herceptin work for everyone who is HER2/neu positive?

Unfortunately, no. There are other cellular factors involved that are not yet well understood. However Herceptin is often combined with other chemotherapy agents to make it more effective.

Are there any other cancers in which HER2 testing is useful?

Cancers of the stomach and lower oesophagus may be HER2 positive. The use of Herceptin is also approved in Australia in cases of HER2 positive advanced cancer of the stomach, where anti-cancer medications have not yet been commenced.

Last Review Date: October 4, 2022

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