Where to get Bayer HER2 Serum testing

[AlaskaAngel]

I think somebody at this site took pity on me when I was going in circles trying to figure out where to get tested with the Bayer HER2 Serum test... Here is the info I received. It would be ordered by your physician:

The HER2 serum test is available at the following national reference laboratories:

Specialty Laboratories, test #1836. Telephone 800-421-4449
Quest Diagnostics, test #15113. Telephone 206-623-8100
Lab Corp, test #480136. Telephone 800-676-8033 or 206-861-7100
ARUP, test #0098615. Telephone 800-522-2787

I checked with each of the four labs, as the lab I was using sent the last samples sent to another lab with a different range of normal values as their machine was "broken".. That was Specialty Lab and I checked with them today and they have no plans to resume performing serum her2neu ECD by the Bayer Diagnositics method. Then I called ARUP and they do serum her2neu ECD by the manual ELISA method, not the Bayer method, and it too had a different range of normal values. Quest also uses a different method with different normal range, so if you want the Bayer diagnostic automated ELISA method whose normal value is <15 (very important to have reproducible results if you want to follow the result longitudinally and utilize it to judge response to Herceptin), utilize the Lab Corp. test.

I got the same list from Walt Carney of Bayer Diagnostics/Oncogene, who had not yet done the legwork to discover which of those labs was actually utilizing their machine/method.

Hope this saves you some bother!

[AlaskaAngel]

I am glad you responded, Lani. I received the list directly from a person who indicated she works at Bayer and should have checked it out prior to posting it. I will contact her and ask for an explanation. I think it may have been me who confused things with Dr. Carney, regretfully. A good lesson for me, thanks.

A.A.

[Julie2]

I am getting my He2 ELISA serum test done at Quest diagnostics which has a range of <13.2 as normal. I am worried to know that this is not the original Bayer serum test which is approved by FDA. My result is always being less than 7 since I started testing. Should i get it tested at a different lab?

thanks,
Julie

her2neu serum ecd is only validated in metastatic breast cancer patients.

In those that are metastatic, a decrease of 23% of serum her2neu levels from pre-herceptin test to a test result 1-2 weeks after the initiation of herceptin is felt to predict efficacy of herceptin in that patient, even if the patient's pre-herceptin her2neu level was not >15.

It seems you do not have distant metastases, so there has been no validation of the meaning of the test results in your case. That does not mean there is no validity, it has not been tested in the setting of breast cancer without distant metastasis, and it seems there is not much interest among the oncologic community in extending it to be a test looking for recurrence in those with NED except the Bayer people.

As more and more testing for her2neu is done, and done better and as more and more patients are treated with Herceptin, we must hope the test will be validated in more patient settings and available more widely.

Hope this helps!

[AlaskaAngel]

Not everyone here is a specialist in lab tests (and obviously I am not) but I'm hoping that if enough of the players involved see how to make best use of the information it will help us all...

Here's the response I received from my inquiry, in which I had given Lani's comments:

"Actually both the ELISA and automated HER2/neu serum tests are Bayer products. The methods differ. One is more hands on (ELISA), the other is run on a special analyzer (automated). The ELISA test is distributed by Dako, which may add to the confusion. They both measure the extracellular domain (ECD) shed into the blood and offer a great monitoring tool to the oncologists and patients.

Thanks for the heads up regarding Speciality Labs. I called myself and was told that the test had recently been inactivated with no replacement. I searched the website and was unable to find the test listed any longer."

[AlaskaAngel]

Lani, I'm not sure I fully comprehend your response about being tested with the serum HER2, and the difference in values depending upon which method is used. You indicated the ELISA is an automated test; however, the Bayer rep indicated that ELISA (which is also a Bayer assay test, but is simply offered through DAKO instead) is manual.

"so if you want the Bayer diagnostic automated ELISA method whose normal value is <15 (very important to have reproducible results if you want to follow the result longitudinally and utilize it to judge response to Herceptin), utilize the Lab Corp. test.

So Lani, are you saying that the ELISA by Bayer is offered in 2 versions, one being automated and the other being more manual, and we need to use a lab that offers the automated ELISA by Bayer and not the more manual ELISA offered by Bayer? But the rep seemed to be saying that the hands-on ELISA by Bayer is not automated (or maybe just less automated?), and that the automated method offered by Bayer is not ELISA.

A.A.

I am waiting to hear back from Walt Carney who has been on vacation.
He is with Oncogene, a company that was bought by Bayer Diagnositics. I do not know who makes the assay for the manual ELISA--I will recheck the article on the 23% reduction on her2neu ECD as showing response to Herceptin but I believe they utilized the automated ELISA.

When I called each lab, I inquired as to their normal range. The one used in the paper was the assay with the "<15" normal range.

I remember DAKO as being the company that makes the Her2 test to be performed on the tissue sample, not the serum, but would be happy to learn if they also make a serum her2neu test measuring extracellular domain (shed
her2). Many of the people answering the phone at these companies are not aware of the difference between the serum and the tissue her2neu tests.

Specialty Lab sent specimen(without asking first ) to another lab when their machine was broken which utilized a different normal range.

Will add interesting paper to the her2 group topics area in a few minutes--

regarding serum her2neu levels found useful in identifying prostate cancer progression. Let's hope this makes the testing more readily available ie, more labs buy the Bayer/Oncogene equipment and that the testing becomes more reproducible ie, everyone agrees on the best way to do the test and performs it well.

Hope this helps!