Hi Lu Ann. I would certainly talk with your Oncologist about the test. The test is cleared by the FDA for monitoring patients with metastatic breast cancer. Most likely they won't know much about it. Let us know and perhaps we can provide information to help the Oncologist to understand the value of the test for their patients. You can also ask them to go to the www.oncogene.com website. Please keep us informed as to your progress and let us know what we can do from the education point of view.

Hi Toril. i would contact Lab Corp and Quest to see how to get the test done in Norway. if you go to our website, www.oncogene.com it will link you to Lab Corp and Quest. I am also checking with my colleagues at DAKo and Bayer concerning more specific information about Norway. I'll let you know when i find out.

Thank you Lolly. Let us know how you make out with your Oncologist.
We don't yet have any data concerning serum HER-2/neu and brain mets. Dr Lotz in Paris has told me he is interested in doing such a study.

Susanne. There are a number of reports that patients can be HER-2/neu negative by IHC or FISH and have an elevated serum HER-2/neu. This can have a number of reasons. One reason is that the original biopsy showed too few HER-2/neu positive cells to score the specimen positive. This iisn't a mistake by the pathologist but what is seen under the microscope. With respect to IHC, a pathologist scores the patient as HER-2/neu positive if greater than 10% of the cells seen under the microscope are 3+. It is certainly possible that someone who has 5% IHC 3+ cells at the primary diagnosis is designated HER-2/neu negative according to the guidelines for scoring patients. It is also possible that these HER-2/neu positive cells are the ones that spread to other parts of the body and grow. As these HER-2/neu positive tumors grow they can shed the HER-2/neu fragment into the blood. As the tumor grows and goes to more sites, the concentration of shed HER-2/neu can build up to detectable levels in the blood. We can then detect the elevated levels in the serum of the patient with the test. I think it is becoming clear that someone with an initial HER-2/neu status of HER-2/neu negative should be re-evaluated. An elevated serum HER-2/neu can then be used to go back and test the primary tumor again or to test a metastatic lesion. If either the primary or the metastatic lesion is now HER-2/neu positive by IHC or FISH the doctor can consider Herceptin for the patient. At this time, the serum HER-2/neu test is not approved to place patients on Herceptin but it can be informative.

Dr. Carney,

That is a very interesting use of the serum Her2 neu test. My concern is that a lot of women who are certifiably Her2 positive are having a hard enough time getting their oncologists to order the serum test. I can't imagine how anyone who tested negative could get their oncologist to do it.

Thank you,
SusanAnne

Hi SusanAnne. I understand your concern but it is all about education. When we first observed this back in 1999 people thought we were making up this type of data or not interpreting the published data correctly. As more an more studies have been done we have seen more evidence showing the observation is real. A patient can be HER-2/neu negative by tissue testing and have an elevated serum test. However, the thought leaders are catching on. Oncologists are starting to get the message. DAKO and Bayer are going to make a strong effort this year to increase the awareness that not all HER-2/neu status designations are correct. Like everything else in medicine, it takes time to educate people and on the other hand we don't want to be adopting tests and drugs that really aren't good. Good tests and good therapies will stand the test of time. My hope is that the serum HER-2/neu test will help many patients with breast cancer as new anti-HER-2/neu therpeis are being developed like Lapatinib from GSK. Herceptin is a good therapy and hopefully the next generation of HER-2/neu therapies will be even better and the serum HER-2/neu test will help identify more HER-2/neu positive patients that are not identified by tissue testing. I think in the end, combining both tissue testing with serum testing will identify all patients with HER-2/neu positive tumors and that we won't miss those incorrectly designated HER-2/neu negative. Again, it is all about raising awareness and educating oncologists and patients so that both groups are armed with the best information.

Dr. Carney,
I want to thank you for providing the link to the onco gene wesbsite, and the brochure material for printouts...I passed it on to my oncologist, and today he ordered the test for me and another lady at my clinic...we'll have the results hopefully by the end of the week, and we're all excited to know what the test shows, as neither of us respond to any of the standard tumor marker tests.

Thank you!
Lolly

kat in the delta
 

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

Interview with Dr. Carney
 

Found this today while surfing.

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

Regards
Joe

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.

kat in the delta
 

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

kat in the delta
 

Did you ever take the Bayer Serum test?? I asked my Onc. and he said it was not approved to even use yet. I am stage III, have finished herceptin and all.....I would like to take it in a month and every month for monitoring my HER-2 status.
Has anyone in here taken the Bayer Serum test even if you do not know for sure that it has metastas. to another place ???? kat in the delta

What are these tests for?
 

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