Bayer Serum Test - Dr. Walter Carney
 

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

no for Caryn

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

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

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.

Quest lab - is it reliable?
 

I am getting this test done. It is a Her2 ELISA test from Quest Diagnostics. But the range for this test is 0-13.8 which is different from the regular one which has <15 as normal range. I would really like to know from Dr. Carney if this test is reliable as the regular one.

Julie

I am stage one. I was denied the Bayer Serum test by two oncologists. My current onc after reviewing the CD from Bayer, had no objection to me having it if I wanted to pay for it provided I understood its limits for a stage one. I thought that fair. My other oncs wouldn't even allow it if I paid out of pocket!
I did not start chemo (taxotere)/herceptin until I was 9 months from diagnosis. I have five more months of herceptin to do and now don't know if or when I should have it. I would have liked to have had the test before Herceptin as a baseline of sorts. Are there any on going studies for use of the test for a stage one?
Thanks
Janet

Her2 Bayer serum test
 

I was not sure what Julie was referring to when she mentioned the "regular one" vs the Bayer serum test for Her2+. I thought the only other test was the tissue sampe. Are there 2 different blood tests?
I have a second question. If one was Her2+ and treated with herceptin, would a low test result mean that they:
1) no longer were Her2+ ?
OR
2) did not have metastases?

Julie wrote: "I am getting this test done. It is a Her2 ELISA test from Quest Diagnostics. But the range for this test is 0-13.8 which is different from the regular one which has <15 as normal range. I would really like to know from Dr. Carney if this test is reliable as the regular one.
Julie"

access to this test if not in USA
 

I would like to know if it is feasible to send samples to America to get tested from Australia.ie: would the samples "keep"?

Jackie

I didn't know at the time there was a more specialized test for her2neu - I had the CellSearch test from Immunicon. Those test scores ranged from 0-5 - mine was 0. It took a bit of time to get the logistics worked out to have the test done, but with the 0 I never followed up ...

Bayer HER2 Test
 

Hi:

I have had the Serum HER2 Test performed by ARUP Laboratories in Salt Lake City, Utah every other month since September 2005. The range is 5.1-13.5. I have ranged from 5.5 six days after Herceptin to 12.2 twenty four days after Herceptin.

Barbara

Dr. Carney will begin posting March 9th
 

Dr. Carney will begin posting March 9th


Regards
Joe

I have asked my onc about this test. She had limited knowlege. I do not have mets, however, I would like a "baseline" serum test for the purpose of monitoring.

I will keep pushing to get the test!

Questions RE: Serum HER2 Test
 

Hi:

I responded before and have had the HER2 Serum test since September. I had asked my oncologist and he agreed although I am the only patient in the practice currently getting this test. My questions include:

1) Is it possible that the normal range for Serum HER2 may be higher in post menopausal women?

2) Has Dr. Carney had experience with the Serum HER2 test and early stage breast cancer patients and if so how reliable has he found the test in predicting future mets?

2) In one study of early stage BC the researchers said that the Serum HER2 Test had a 82% relialbity for predicting future mets with patients developing mets at a medium of seven months after the Serum HER2 levels exceed 12. If I interpreted the study correctly would that mean that 18% of early BC patients with elevated Serum HER2 levels did not develop mets during the study period?

Barbara

I'm not sure that Dr. Carney will be ble to answer my questions, given the limited scope of the FDA guidelines. But...

In regards to early-stage patients,
1) Is this test currently in use for early-stage patients?
2) What studies have been done with this test and early-stage patients?
3) What are the treatment implications for an early-stage patient with a rising number? i.e., would the patient be put back on Herceptin while NED?
4) What are the limitations of the test-- how 'accurate' is it, how reliable is it?

If anyone on the site has info on the above, your input would be appreciated.

Many thanks,
Jen

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

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

Where can I find info on all of these Her2 tests?
 

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

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