Bayer Serum Test - Dr. Walter Carney

[Yorkiegirl]

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



Vicki

I have some confusion about the test and how it should be used.
I had a year of Herceptin along with chemotherapy. Pathology indicated I was at least stage III and may have been stage IV. I am now on hormonal treatments. Should I be getting this test routinely or is it for someone who is already on Herceptin? When is it indicated and for whom? What does it indicate? If my levels test within the 'normal, range, would that mean that I was no longer Her2+?

[TriciaK]

My oncologist has not done the Serum test and kind of sidetracked me when I asked about it, almost as if it were new to him. I am now NED, stage IV, dx for the third time in 21 years in July, 2004. I would like to know more about the test, and I'm looking forward to more info from Dr. Carney and hope there is material we can print out and share with our oncologists. Thanks so much for doing this! Hugs, Tricia

[AlaskaAngel]

I haven't asked my onc or my internist about the test yet but last December I asked an onc I consulted for genetic counseling about it right after the San Antonio meeting. I don't think she knew much about it but since I am stage 1 and 4 years out and it isn't used for stage 1 and she isn't my onc we didn't discuss it further. But because stage 1 can turn into stage 4 in a blink of an eye I wonder about getting it as a baseline and then rechecking it if one has symptoms.

AlaskaAngel

[lexigirl]

I asked my onc about the test and she had no idea what I was talking about. It really is tough being that this seems to be really new to her.

Lexi

[Susan2]

I asked my oncologist about the test. She said that there was not a clear course of action once the results were known. Additionally, she said that insurance would not pay for it and the cost was approx. $800.00. Obviously, she was recommending against it.

[Dr. Carney]

Jsattaw. The serum HER-2/neu which is not approved as a prognostic indicator. The current FDA cleared assay is cleared for the management and monitoring of patients with advanced breast cancer who have an initial value of over 15 ng/ml. Please note that any value under 15 ng/ml is normal. The serum HER-2/neu test is available in 2 formats. The manual test (ELISA ) is manufactured by Oncogene Science which is part of Bayer Dx. The manual test is distributed by DAKO. The automated version of the serum HER-2/neu is available on an instrument known as ADVIA Centaur. The automated test and the manual test have the same normal level of less than 15 ng/ml. There is only 1 serum HER-2/neu test cleared by the FDA and therefore the manual test distributed by DAKO and the automated test offered by Bayer are the same test with the same components. Labs that indicate that 12ng/ml is normal are correct but a second test showing that it is 14 ng/ml is also normal.
Research studies are ongoing to understand the clinical value of measuring serum HER-2/neu in early breast cancer but it is not cleared by the FDA for that use.

[Dr. Carney]

Jsattaw. The serum HER-2/neu which is not approved as a prognostic indicator. The current FDA cleared assay is cleared for the management and monitoring of patients with advanced breast cancer who have an initial value of over 15 ng/ml. Please note that any value under 15 ng/ml is normal. The serum HER-2/neu test is available in 2 formats. The manual test (ELISA ) is manufactured by Oncogene Science which is part of Bayer Dx. The manual test is distributed by DAKO. The automated version of the serum HER-2/neu is available on an instrument known as ADVIA Centaur. The automated test and the manual test have the same normal level of less than 15 ng/ml. There is only 1 serum HER-2/neu test cleared by the FDA and therefore the manual test distributed by DAKO and the automated test offered by Bayer are the same test with the same components. Labs that indicate that 12ng/ml is normal are correct but a second test showing that it is 14 ng/ml is also normal.
Research studies are ongoing to understand the clinical value of measuring serum HER-2/neu in early breast cancer but it is not cleared by the FDA for that use.

Dr. Carney;

Thank you so much for posting. Does this mean that if you have metatasic disease but are currently NED the test is useful? I have not taken the test and live in Canada so perhaps it is not available. I would like to monitor my condition (supraclavicular tumor treated with chemo and radiation) going forward to anticipate mets. My oncologist has not used markers in the past but rather blood tests prior to visits. I would like markers such as this used prior to each herceptin treatment. Does this make sense?

Thank you,

Cathya

[Dr. Carney]

Dear KK1:

Thanks – keep us informed about your results.

Regards,
Walt

[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

[jsattaw]

Dr. Carney:

Thank you for taking so much time in responding to our individual queries. We greatly appreciate your willingness to share your expertise and your dedication to research regarding Her2+ breast cancer. The knowledge you provide will also be useful as we work with our individual oncologists to ensure we are receiving the most up-to-date and relevant care or diagnostic tests. Please let us know if there are more formal ways we could become involved as advocates for the serum Her2 test.

Jill

[Dr. Carney]

Julie 2 Thank you for your inquiry. Quest Labs and Lab Corp both perform the same FDA cleared serum HER-2/neu test. So you can feel confident in your results from Quest. Oncogene Science which is part of Bayer DX manufactures the manual ELISA under GMP conditions and DAKO distributes/sells our kit to Quest and Lab Corp. So you can feel comfortable regardless of whether the test is ordered through Quest, Lab Corp or ARUP reference labs because they are getting exactly the same test from Oncogene Science/DAKO/Bayer Dx.
To clarify another issue. Bayer Dx offeres the exact same test but on an automated instrument called ADVIA Centaur. The manual ELISA and the automated serum HER-2/neu test use the same components to measure serum HER-2/neu. The Centaur is available in larger clinical institutions and the instrument runs hundreds of tests per day. Since serum HER-2/neu testing is not at that volume yet, the reference labs such as Quest use the manual ELISA. The components of the manual ELISA and the automated test are identical and give highly reproducible results. The normal value for the manual test and the automated test is less than 15 ng/ml. The serum HER-2/neu test sold by DAKO ( from Oncogene Science) or the autoamted test sold by Bayer DX is the ONLY serum test cleared by the FDA to monitor changing levels of serum HER-2/neu. The most important thing for all patients to find out is who manufactures the test. If it is not Oncogene Science or Bayer it is not the FDA cleared tserum HER-2/neu est. Again, DAKO sells and Distributes the Oncogene Science manufactured test.

Studies have now shown that 10-40% or metastatic breast cancer patients with a negative IHC or FISH test can have an elevated serum HER-2/neu in metastatic breast cancer. As you know, patients negative by tissue testing can't receive Herceptin. The serum HER-2/neu test is not approved to select patients for Herceptin. However, if patient has an elevated serum HER-2/neu then they should have their original primary tumor re-evaluated by the approved IHC or FISH test to see if the tumor is HER-2/neu positive. If the tumor is negative or not available you should discuss with your oncologist testing a metastatic lesion for HER-2/neu positivity by IHC or FISH. If positive, then the patient can be eligble for Herceptin, if the Oncologist recommends it. Once again, the serum HER-2/neu test is not approved for selecting patients for Herceptin but can provide guidance back to the approved tissue tests.

jsattaw
Thank you for your response. I think the best way for advocates to be involved at this point is to share how the serum HER-2/neu is helping or not helping management of treatment. We are in the process of preparing specific educational material that will be forwarded to avocacy groups and Oncologists.
No one test or drug is the answer to managing cancer but the more we learn about tests such as the serum HER-2/neu the better and smarter we will all be. I encourage any patient monitoring the serum HER-2/neu test to continue to do so and let us know the value to the patient. We have several ideas for how this test can help patients but the more feedback we receive the more it will help us.
FYI, we are involved in developing additional tests for breast and other cancers but research takes a long time and implementing new tests and drugs takes along time as well. Our hope is that our efforts will help patients someday. We also wish there was a way to accelerate implementation into clinical practice. However, new tests are implemented slowly to make sure they are valuable to both the patient and the oncologist. Oncologist are overwhelmed with information and that is part of the challenge. Each patient is an individual with a specific genetic background which in itself is a challenge for medical treatment.
Stay tuned to the American Association for Cancer Research (ASCO) meeting in June since there will be serum HER-2/neu data presented at the meeting from the laboratory of Dr Lipton from Hershey Medical School regarding the value of monitoring serum HER-2/neu in metastatic breast cancer patients.

[SusanAnne]

Dr. Carney,


Thank you so much for your time. You stated:

Studies have now shown that 10-40% or metastatic breast cancer patients with a negative IHC or FISH test can have an elevated serum HER-2/neu in metastatic breast cancer. As you know, patients negative by tissue testing can't receive Herceptin. The serum HER-2/neu test is not approved to select patients for Herceptin. However, if patient has an elevated serum HER-2/neu then they should have their original primary tumor re-evaluated by the approved IHC or FISH test to see if the tumor is HER-2/neu positive. If the tumor is negative or not available you should discuss with your oncologist testing a metastatic lesion for HER-2/neu positivity by IHC or FISH. If positive, then the patient can be eligble for Herceptin, if the Oncologist recommends it. Once again, the serum HER-2/neu test is not approved for selecting patients for Herceptin but can provide guidance back to the approved tissue tests.

If a patient's original tumor tested negative by IHC or FISH, why would they have their HER-2 serum tested? Is this something a stage 4 patient should ask for regardless of their original pathology?

Susan

[Cathya]

Dr. Carney;

A very intuitive and knowledgeable member of this forum, Gina, once suggested that in time she hopes someone would develop a device similar to ones used by diabetics which would test for Her2 serum and AC 27/29 automatically and easily. In this way we could monitor our markers closely just prior to each herceptin treatment and if we saw them raising get a booster dose of herceptin to bring them down again. (Forgive me Gina if I don't have it exactly right). I thought is was a brilliant idea. Do you ever see the developement of this sort of device happening in the future?

Thank you for your very imformative postings,
Best regards,

Cathya

[lu ann]

Dr. Carney,

I have been treated for advanced breast cancer since March 2004. I received palliative radiation to my spine and mediastynime.

I have had the following chemotherepies; carboplatin, taxol, navelbine, and gemsar. Since February 04, I have had monthly zometa treatments. Herceptin was given along with chemo except when I was on a break.

I have been currently on a break from both chemo and herceptin since December 19, 05. I will be on a break atleast until early May unless things start to progress.

My last CT scan showed stable disease with improvement of the pleural effusion.

When would be the most opportune time for me to get the Bayer surum Her2 test?

Thankyou
Lu Ann

[Toril]

I don't know if it is possible for you to answer this: But will this test be available in countries outside the US? I just heard about it, sounds interesting - and of course I'll ask my onc next time I see him. I live in Norway.

Thanks!
Toril

[Lolly]

Dr. Carney,

Thank you for providing information to us on the serum Her-2/neu test. I've discussed the test with my oncologist previously, and will print out the info from your web site for his review. I'll find out if he wants material sent to him and we'll "stay tuned" for the news from ASCO this June

Best Regards,
Lolly

[Lolly]

P.S. to Dr. Carney,

Has the test been predictive of brain metastasis in patients otherwise showing NED?

Regards,
Lolly