Bayer Serum Test - Dr. Walter Carney

[lexigirl]

I just came from an appt w/ my onc. She isn't aware of the her2 tests and had no idea about the topo2 test. I think this must be really new to Kaiser. She sort of looks at me like I am a little far out there.

Lexi

[SusanAnne]

When I first asked my onc. last year about this test, he did not know of it. After reading the material I had Bayer send to him, he felt that it was useful to only stage 4 patients (I'm stage 3) so I have yet to do it. Are there any trials available to participate in?


Susan

[skoolmom]

I'm not informed on all of these tests you guys are talking about, could you tell me where to go to get info on all of them. And what exactly are they testing?
Thanks

[Helen]

I have asked my onc if I can have this test and he said they are not accurate. How can I convince him to give me this test?

Helen

[Yorkiegirl]

My Onc won't do the test. He FINALLY just did a CEA and Ca27/29 on me.



Vicki

[Dr. Carney]

KK1

Thanks – keep us informed about your results.



Sarahdalton

Below is information from my colleague Dr. Rainer Neumann concerning who you can contact in France to get the serum HER-2/neu test. Dr. Rainer’s phone number is 011 49 214 308 2084 and his email address is rainer.neumann.rn@bayer-ag.de. In case of any problems the patient can call him or send him an e-mail and if they prefer in French.



Hospital Tenon

attn.: Dr. Didier Brault tel # 0033 1 5601 6433

e-mail didier.brault@tnn.ap-hop-paris.fr



Dr. Rainer suggests if a patient needs a clinician to talk to in France contact:

Prof. Jean-Piere Lotz or Dr. Joseph Gligorov.



Professor Jean-Pierre Lotz

Université Pierre et Marie Curie (PARIS VI)

Chef du Service d'Oncologie Médicale, Hôpital Tenon

4, rue de la Chine. 75970 Paris cedex 20

Tel / Fax : 00 33 (0)1 56 01 60 58 / 68 75

mail professionnel : jean-pierre.lotz@tnn.ap-hop-paris.fr

mail personnel :jeanpierre.lotz@wanadoo.fr



Dr. Gligorov`s telephone number is: 0033 1 5601 6024, e-mail: joseph.gligorov@noos.fr or Joseph.Gligorov@tnn.ap-hop-paris.fr.



When contacting Drs. Didier or Joseph the patient should mention they received the addresses via Walt Carney or Rainer Neumann.



Sherri

We are checking on the availability in Canada. Studies have shown that the serum HER-2/neu test is accurate and reproducible in the presence of Herceptin. It does show the real number. Oncologists differ on this topic, since most are not aware of the test or understand the test. We are taking steps to increase education of oncologists regarding serum HER-2/neu.



Julie 2

As I indicated to jsattaw, the normal value for serum HER-2/neu is any number under 15 ng/ml according to our FDA indications. The Quest test is the manual test manufactured by Oncogene Science/Bayer HealthCare and distributed by DAKO. The Bayer serum HER-2/neu tests (both manual and automated) are the only serum HER-2/neu tests cleared by the FDA. Quest is allowed to determine a normal value, which is 13.8, however, it is under 15 and still normal. Results from Quest are very reliable and reproducible.



Janet/F1

Your oncologist denied the test because you have stage 1 breast cancer. The test is not yet approved for early breast cancer. Studies are ongoing to understand serum HER-2/neu in early breast cancer.



Kaye

There is only one serum HER-2/neu test as I described to jsattaw. There are 2 tissue tests, IHC and FISH. There is only 1 blood test for serum HER-2/neu distributed in the manual ELISA by DAKO or in the automated form by Bayer. Both the manual ELISA and the automated test give the same results. Both the automated and manual ELISA tests use the same component and therefore are the same test. DAKO does not make a serum test, but sells the manual ELISA manufactured by Oncogene Science/Bayer HealthCare. Normal is less than 15 ng/ml. Low test results means there is very little circulating HER-2/neu. Although the serum HER-2/neu is less than 15 ng/ml, that doesn’t tell us if the tumor is HER-2/neu positive or negative. Only when the serum test is greater than 15 ng/ml do we know that a HER-2/neu positive tumor is present.



Jhandley

We will check with LabCorp and Quest on this.



Shell

The cell search test measures circulating tumor cells. This is still an area of great research and potential clinical benefit, but still in its infancy. The serum HER-2/neu test measures the amount of HER-2/neu protein released into the blood stream from the surface of HER-2/neu positive breast cancer cells.



Barbara

All your results remain less than 15 ng/ml and therefore normal.



Joe

Sorry I was late posting. I got a new computer today and things were slow.



Athena 453

If you want to send me the name of your oncologist and their address, we can provide information on the serum HER-2/neu test. Alternatively, you can go to our website at www.oncogene.com for information to share with your oncologists.

Barbara
1. Our studies show that 95% of all normal people fall below 15 ng/ml.

2. There is not enough data so far to correlate serum HER-2/neu levels in early stage breast cancer and predicting future mets.

3. It is hard to comment on this study. Could you send me the journal reference so I can review?



Saleboat

1. The serum HER-2/neu test is only cleared for monitoring in patients with metastatic breast cancer. There are studies examining the value of serum HER-2/neu in early breast cancer, but no approval for such an indication.
2. There have been a number of studies in early breast cancer. These are reviewed in a Clinical Breast Cancer article "Monitoring the Circulating Levels of the HER2/neu Oncoprotein in Breast Cancer" June 2004, Walter P. Carney, et al.
3. This is a decision by the oncologist.
4. The test is very accurate, very reliable and very reproducible. The FDA required substantial data to prove that, and based on the data cleared the test for monitoring metastatic breast cancer patients.

Lexigirl

If you would provide me with the name and address of your oncologist, I will send them information about the serum HER-2/neu test. Our website is www.oncogene.com.





Susan Anne

Currently, the test is only available for metastatic breast cancer patients, but research studies are ongoing looking at serum HER-2/neu in earlier breast cancer.



Skoolmom

Please go to our website www.oncogene.com and you can see how to get the test at Quest, LabCorp or ARUP. The serum HER-2/neu test measures the amount of HER-2/neu protein released from HER-2/neu positive tumor cells. This is different than the IHC tissue test. The tissue measures the amount of HER-2/neu protein attached to tumor cells and when looking at the HER-2/neu positive tumor cells under a microscope.



Helen

The test is accurate, reproducible and reliable. Otherwise the FDA would not have cleared it for testing. If you want to provide the name of your oncologist and address, we will make sure they get the information. You can also go to our website www.oncogene.com as well.



Yorkiegirl

Please provide us with the name of your oncologist and address and we can provide information. Alternatively, you can go to our website www.oncogene.com.



Kaye

The serum HER-2/neu test is cleared by the FDA for monitoring blood levels of the HER-2/neu protein in women with metastatic breast cancer. So it is indicated for patients with metastatic breast cancer. Studies have looked at patients who have received a variety of therapies including hormone therapy. The test is indicated in patients with metastatic breast cancer, regardless of treatment and is valuable in monitoring changes in serum HER-2/neu levels. Increasing serum HER-2/neu levels reflect progression and decreasing levels reflect response to therapy. Having values below 15 ng/ml only tells us that the number is normal, it doesn’t tell us if you are HER-2/neu positive.



Triciak

There is information on our website www.oncogene.com. You can also give us the name and address of your oncologist and we will provide information.



Alaska Angel

Since the test isn’t approved for stage 1, I would continue to learn more about serum HER-2/neu and help educate your oncologists. Oncologists are overwhelmed with information and if patients can help educate the oncologists (keep it simple) we all benefit.



Lexigirl

You can go to our website www.oncogene.com and also send me the name and address of the oncologist and we will provide educational materials.



Susan 2

Sounds like we need to educate your oncologist. Going to our website www.oncogene.com will help. We can send your oncologists information if you want. I think the $800.00 cost is wrong, but I personally don’t know what Lab Corp or Quest charge.

[Julie2]

Hi Dr. Carney,

Thanks for replying to my concern about the Her2 serum test done by Quest lab. As I don't have access to Labcorp(very far from where I live) which does the FDA approved her2 serum test, is it OK for me to do the test in Quest lab? Is the theory behind both the tests same except that one being manual and other automatic? Can I continue with Quest lab with out having any suspecion?

Thanks so much for answering all our questions.

Julie

[koolbreeze]

I am with skoolmom, I am not familiar with these tests. What do they do? What is the purpose? Thanks

[kat in the delta]

The websites for these tests areon this page and the previous pages. Look at Joe and the site given by Dr. Walter P.Carney. They are approved for Metatas. Breast C. which is Her- 2+++, for monitoring Her-2 thru a blood test. Ask others--mine has not gone beyond lymph nodes (as far as I know now). kat in the delta