HER2 Support Group Forums - View Single Post - Bayer Serum Test

Dr. Carney · 03-11-2006, 12:42 PM

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.

03-11-2006, 12:42 PM	#34
Dr. Carney Member Join Date: Feb 2006 Posts: 11	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.