[Joe]

1. The serum HER-2/neu test was cleared in 2000 by the FDA for the management and monitoring of women with metastatic breast cancer, however, it should be noted that many clinical research studies have shown that women with early breast cancer can also have elevated ( greater than 15 ng/ml) serum HER-2/neu levels

2. The test has been standardized, is highly reproducible and is manufactured under Good Manufacturing Practices (GMP).

3. In addition to Quest, Lab Corp, ARUP and Pathway DX ( all reference labs) all offer the test. Siemens does not license any one reference lab to offer the test

4.The Siemens serum HER-2/neu test is the exact test sold by Bayer Dx and Oncogene Science. Both Bayer Dx and Oncogene Science were acquired by Siemens.

5.Siemens is the only manufacturer of this test. It is known as an Oncoprotein test and is not a traditional tumor marker like CA 15-3.

6. The serum HER-2/neu test is a simple blood test and it specifically measures the levels of the HER-2 protein released by the cell into the blood.

7.. Normal breast cells release the HER-2 protein into the blood. The normal level is less than 15 ng/ml. Patients should considered any number less than 15 ng/ml as normal and it doesn’t matter if the patient is 8,10, 12, or 14.

8.The blood test is very simple and the test needs very little blood to measure the amount of the HER-2 protein in the blood.

9.Increasing levels of the HER-2/neu protein in the blood reflects tumor progression while decreasing levels reflect response of the tumor to therapy.

10.Medicare and some insurances pay for the test.

11.Increasing levels may be the signal to do scans.

• The serum HER-2/neu test is an additional tool for managing breast cancer patients and should always be used in conjunction with other diagnostic tools

• Some women that are said to be negative for a HER-2 by tissue testing (IHC or FISH) can have elevated serum HER-2 levels at the time of metastatic breast cancer. Women with elevated levels and a negative tissue test should have their original tumor re-tested by IHC or FISH or a biopsy of a metastatic tumor to check the HER-2/neu status.

• More education is needed to inform breast cancer oncologists, so they will know that the test is available, is standardized, is FDA cleared and is reliable

• Serum HER-2/neu levels will fluctuate depending on the behavior of the tumor in response or lack of response to therapies.

• The test should be done on all women with metastatic breast cancer and repeated 3 or 4 times a year. The test is dynamic and changes with growth of the tumor or the shrinking of the tumor. The test is a real time test and will help physicians manage patients with HER-2 positive tumors since increasing levels reflect cancer progression while decreasing levels reflect the response of the tumor to treatment. The serum HER-2 level reflects the behavior of the tumor and is independent of the therapy type

• ASCO does not endorse the use of any tumor markers or the HER-2/neu oncoprotein, however, in the Jan 2007 issue of the Journal of Clinical Oncology guidelines were published which provided a substantial summary of the serum HER-2/neu data indicating the importance of the test.

• There is a substantial amount of data and information published on the serum HER-2/neu test which patients should offer to their oncologist to read. Physicians are incredibly busy and need help from advocates to stay current.

• HER-2/neu positive patients can be either lymph node negative or lymph node positive. They are independent factors.