Bayer Serum Test - Dr. Walter Carney

[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

[Dr. Carney]

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.

[Dr. Carney]

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.

[Dr. Carney]

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.

[SusanAnne]

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

[Dr. Carney]

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.

[Lolly]

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