Bayer Serum Test - Dr. Walter Carney

Joe · 02-25-2006, 09:04 AM

The HER2 Support Group has invited Dr. Walter Carney to be our first guest poster on our message boards. He will be answering any questions that you may have related to the Bayer/Oncogene Serum HER-2?neu Test.

However, due to stringent FDA regulations, Dr. Carney cannot answer any personal health questions nor can he speculate outside of what the boundaries of the FDA claim for this test.

He will however be able to clear up confusion about the test value cutoff values (12 versus 15) The availability of the test, what the test measures, etc.

In preparation for Dr. Carney's visit, it would be helpful if you could post the following information:

Are you currently being monitored by this test?
Was there any difficulty in requesting this test?
What Cancer Centers are currently performing this test?

If for personal reasons, you wish not to post this information online, you may email me at: Joe@her2support.org

Warmest Regards
Joe

jsattaw · 02-25-2006, 02:07 PM

I shared the CD from the San Antonio conference with my oncologist who is with Oncology & Hematology Associates of Central Illinois (based in Peoria, IL). As far as I know, they are not utilizing this test as a prognostic indicator and I have not yet been tested.

I do not have mets -- am Stage II due to a local recurrence.

Based on my understanding of the test, it has not been proven for early stagers...yet.

Jill

eric · 02-26-2006, 04:31 AM

no for Caryn

kk1 · 02-26-2006, 09:42 AM

I am currently being monitored by the bayer serum test
I had no problem requesting the test from my onc or my insurance.
I get the test done at Labcorp, my cancer center lab (University of Miami/Slyvestor) does not do the serum test but labcorp is in the basement of the bldg. so it is no big deal to get the blood drawn just before my 3-week herceptin.

kk1

sarah · 02-26-2006, 10:21 AM

here in France, they don't offer it but then they don't know about the CA27,29 either.

sherri · 02-26-2006, 01:10 PM

In Canada they don't have this test yet. So no for me. My oncologist said when you are on Herceptin, it does not show the real number! He thinks if I want to do it in US, it's better I wait and do it after I fininsh Herceptin. No idea if he is giving me the right info about the test.

Dr. Carney · 03-10-2006, 10:33 AM

Dear KK1:

Thanks – keep us informed about your results.

Regards,
Walt

kat in the delta · 05-13-2006, 09:27 PM

Dr.Carney,
Can you give other websites for my Onc., orignally from Damascas, Syria, and my husband who is a pharmacist at our hospital?? My husband will not listen to me. Thanks,Kat

Dr. Carney · 03-09-2006, 07:59 PM

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 · 03-09-2006, 08:02 PM

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.

03-09-2006, 09:17 PM

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

03-06-2006, 12:05 AM

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 · 03-09-2006, 12:27 PM

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 · 03-09-2006, 01:30 PM

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 · 03-09-2006, 01:33 PM

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 · 03-09-2006, 03:55 PM

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.

kat in the delta · 04-30-2006, 12:59 AM

JOE,
What is the Bayer Serum test?? if you can tell me--thanks,kat

Joe · 05-01-2006, 07:48 AM

Found this today while surfing.

http://www.healthtech.com/newsarticles/issue65.ASP

Regards
Joe

Lolly · 05-10-2006, 06:30 PM

I'm going to post the results of my Bayer Serum Tests here, will update with each test.

Oncogene Science HER-2/neu Microtiter ELISA (Reference: 5.1-13.5 = normal range

03/28/06 - 12.7
04/25/06 - 11.5
05/24/06 - 6.8

Am currently on 2 weekly Herceptin with continuous low-dose Xeloda. Have been on Herceptin/+or- chemo since 2001 for systemic disease in lymph system. Initial tumor marker analysis was with CEA, but levels were no longer elevated at third recurrence in Oct.2005. First HER-2/neu Serum test was performed (and Navelbine stopped) one month after starting Xeloda.