Bayer Serum Test

[Joe]

Earlier this month, Christine requested that members post any questions or difficulties that they had encountered with the Bayer HER2 Serum Test.

Dr. Carney's group have addressed most of these problems. Attached is their answer anlong with the original questions:

Christine

Hi, please encourage your readers to try this new website to learn more about serum HER-2/neu test for patients with metastatic breast cancer.



www.neunews.net.

05-28-200601:51 PM

Urgent - HER2 Serum Test by Bayer


We need feedback prior to our trip to ASCO. There, we will be meeting with Dr. Carney. We would like your viewpoint on the value of this test and/or your doctors.

Hugs
Christine






heblaj01

05-28-200602:27 PM

Christine,
A question related to the sensitivity of the test.
Could you find out how early in the progression of HER2 cancer does the Bayer test show a usefull change ? (I assume when the measured level goes above 15ng/ml or is it otherwise?).

Response



Yes, increasing values above the normal cut of 15 ng/ml are reflective of disease progression. There have been a few studies directed specifically at answering this question, and they indicate that serum HER-2/neu values increase many months prior to the actual clinical signs of progression. It is difficult to give the exact number of days or months when this could happen, since women with breast cancer release the serum HER-2/neu into their blood at different rates.


In other words will tumors be already be large enough to be detectable by other means (physical examination, scans, etc or before that stage?

RESPONSE

In some of these studies the increase in serum HER-2/neu was seen prior to actual clinical signs detected by imaging techniques.

Besides the big advantage of being non invasive does the test appear to be more sensitive than the FISH & IHC tests done on biopsies?
Thanks in advance.



RESPONSE


It is really not possible to do head to head studies comparing FISH and IHC done on tumor cells with and the Bayer Serum HER-2/neu Test which is done on a blood specimen since the 3 tests measure different components in a tumor cell. FISH and IHC are tests that are performed on the breast tumor cells removed at surgery. FISH looks at the number of copies of DNA in the nucleus of a cell to see if there are more copies of the HER-2/neu gene in women with breast cancer than in women without breast cancer

IHC measures the amount of the intact HER-2/neu protein in and on the surface of the cancer cells. IHC is performed on the original tumor removed at surgery and measures the number of HER-2/neu proteins in the cell and like FISH the result is reported by a Pathologist. Cells found to contain HER-2/neu proteins are scored according the intensity of staining for each cell and the number of cells that are actually stained. Intensity is scored 3+, 2+ etc. Only those women who have more than 10% of 3+ HER-2/neu positive cells are considered HER-2/neu positive. However, it is very important to understand that a patient who has only 5-8% of the tumor cells staining 3+ are considered HER-2/neu negative and are not candidates for Herceptin. However, the 5-8% of 3+ positive cells can certainly be the basis for future metastatic tumors, which can be HER-2/neu positive. Therefore, re-examing a woman’s HER-2/neu status at the time of metastatic breast cancer diagnosis is important. This can be done with the Bayer Serum HER-2/neu Test which is a simple blood test. In comparison to FISH and IHC, which are performed on solid tumor (cells are examined individually from the tumor mass) the Bayer Serum HER-2/neu Test measures the outside protion of the HER-2/neu protein that is released into the patient’s blood. Through clinical studies it has been established that 15 ng/ml is the normal cutoff for this test.

The Bayer Serum HER-2/neu Test is used for monitoring or tracking changes HER-2/neu levels in the blood of women diagnosed with metastatic breast cancer. If a women is below the normal range (less than 15 ng/ml) she should be checked a few times a year to see if the number increases. Once the number increases above 15 ng/ml, she should be monitored more often for changing HER-2/neu levels. Many studies have shown as well as the clinical trial data submitted and approved by the FDA that increasing serum HER-2/neu values reflect disease progression (sometimes this is not yet visible by imaging) while decreasing values reflect therapy response or stable disease. If levels start rising above the 15 ng/mL normal cutoff, at this point your doctor may want to run other tests for signs of disease progression.

It should also be noted that several published reports in medical journals have shown that there are patients ( approx 20%) who are HER-2/neu negative by FISH and IHC but who have a serum HER-2/neu value above the 15 ng/ml. These women are not eligible for Herceptin. However, if a patient is shown to have a elevated serum HER-2/neu, which is reflective of a HER-2/neu positive tumor, then the primary tumor or a metastatic lesion should be examined by IHC or FISH to see if the patient is in fact HER-2/neu positive. If so, she can now be a candidate for Herceptin if that is the decision of her doctor.

Therefore to summarize, FISH and IHC are tests that examine cancer cells in the original tumor mass for either abnormal high levels of HER-2/neu genes or abnormally high levels of the HER-2/neu protein. The Bayer Serum HER-2/neu Test is the only test cleared by the FDA to measured and monitor the circulating HER-2/neu protein in patients diagnosed with metastatic breast cancer. It measures the amount of the outer portion of the HER-2/neu protein circulating in the blood which we refer to as serum HER-2/neu. It is test very similar to measuring PSA in men. FISH and IHC are basically one time tests performed on the original tumor removed at surgery but the serum HER-2/neu test can be used repeatedly in patients with metastatic breast cancer. Metastatic breast cancer is cancer that has migrated beyond the breast to lymph nodes or other parts of the body, such as liver, bone, brain and these are the patients eligible for the test.



Lolly

05-28-2006 05:09 PM

Christine,
Here are the results so far on my Bayer HER2 Serum test:

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.



RESPONSE
Sounds like your oncologist is using the serum test for its intended use “for the management of your breast cancer”. Please keep us informed about your clinical status in relation to your serum HER-2/neu values and let’s hope you stay healthy and the numbers stay stable.




<3 Lolly




Cathya

05-28-2006 07:04 PM

Christine;

The doctor in Toronto from Dako was in California and apparently brought them the completed application for the Canadian Gov't. I would love it if you could ask if this has been submitted yet. Dako has agreed to bring the test into Canada even on a research basis but can't until it is registered with the government and there is a lab which will agree to do the tests. So far they have not agreed to do so for Canadians. Could you ask about that as well? Thanks

RESPONSE

We know that DAKO is working on a solution. Thanks for your patience. They are trying very hard to find a way to offer the test in Canada, but due to policies of the Canadian government, they have not yet received permission to distribute the product in Canada. Bayer uses DAKO to distribute the test in Canada and we are working with DAKO to find a way to offer to the test in Canada, but have not yet been successful.
Cathy




Cathya

05-28-2006 07:05 PM

Christine;

My onc has agreed to have me use this test and we're just waiting.

Cathy

RESPONSE



Please keep up to date with your results.






jhandley

05-28-200609:31 PM

for Australia


Please ask them about getting this test into Australia. Gina swears by this test as an indication of mets. It is also supposed to indicate mets many months before detectable by other means...so if your value was low and you went off herceptin you could go back on it when your numbers started to rise.

Jackie



RESPONSE




We are still working on Austrialia but don’t yet have an answer. Gina is correct and well informed. Studies have shown that serum HER-2/neu levels can increase prior to actual imaging results. However, coming off Herceptin may not be a good idea as you suggest at this time. No one yet knows the effect of doing that. It could allow tumors cells being held in check by Herceptin to start grwoing again.

Hopefully, one day, biochemical blood tests like serum HER-2/neu will be used very early to detect cancer and to apply HER-2/neu targeted therapies earlier while the tumor burden is lower. Perhaps someday biochemical tests will be used to manage therapy but for today the standard is to use imaging results.



Using the Bayer Seurm HER-2/neu Test to optimize therapy as you indicate is the important value of the test. By measuring serum HER-2/neu levels, it will allow your oncologist to directly manage the therapy for a HER-2/neu positive tumor. Your example is a good one and a cost effective one. As alternative therapies such as Tykerb are approved an increasing serum HER-2/nel level that is reflective of disease progression may aid physicians in applying new HER-2/neu directed therapies. In addition to the GSK drug Tykerb, there are several other major Pharmaceutical companies trying to develop similar drugs to Tykerb with the hope that they will be even more effective.

DeborahNC

05-29-2006 05:11 AM

Can you ask how one can convince one's onc to give the test? My onc just waves away any suggestion of it.



RESPONSE



Please send us the name and address for your oncologist and we will provide the information to your oncologist. New things are often resisted early on by many people. It is easier to wave something off than to take the time to understand new possibilities. Many oncologists are extremely busy and don’t have time to keep up with all the medical literature. It is really a matter of showing them examples of how the test can help treat patients. They are also trying to do the best for their patients and sometimes it is difficult to factor in all the new information on drugs and tests. Our best approach is to continue providing educational materials to breast cancer patients, to doctors and others within the healthcare community to increase the awareness and understanding of the value of a specific test to track HER-2/neu positive tumors. Estrogen receptor has been the major test to guide hormone therapy, in a similar fashion knowing the HER-2/neu status will guide therapies to attack HER-2/neu positive tumors. Hormone therapy, Chemotherapy and HER-2/neu targeted therapies alone or in combination can all be used today to manage patients with HER-2/neu positive tumors and we believe the serum HER-2/neu test is an important management tool to do that.



Also, your doctor can visit a new website that is dedicated to spreading awareness and education about the Bayer Serum HER-2/neu Test. This site was developed by Oncogene Science for DAKO who distributes the manual version of the serum HER-2/neu test manufactured by Oncogene Science. This site is called www.neunews.net. There is a section for providers and one for patients.




Cathya

05-29-2006 06:09 AM

Yes, onc's don't seem to like...or rather trust these tests. Although my onc agreed to the test he did comment that the FDA is still hesitant because they only approved it for metatastic disease not early disease. He said results from all these markers give false negatives and positives and cause a lot of stress. However, if we can get it he will use it. So lets work on that.

Cathy



RESPONSE



The FDA only approves or rejects data that is submitted to them along with an intended clinical use. In September 2000 the FDA cleared the serum HER-2/neu test submitted by Oncogene Science/Bayer Dx for both the manual and automated format of the test. It is the same test in 2 formats for large and small laboratories. They cleared it for use with metastatic breast cancer patients only because that is all the data that was submitted at the time. FDA cleared the test for the clinical indication requested.

The reason why the test is not approved or cleared by FDA for earlier stage breast cancer is because an application for an earlier and different indication for breast cancer has not been submitted yet. Unfortunately the comment “that these markers give false negatives and positives” is true of many tests. But, tests like the serum HER-2/neu test do provide important information for managing and optimizing therapy for some HER-2/neu positive breast cancer patients. Cancer and cancer proteins still present many challenges and we refer to things as false negatives or false positives mostly because we still don’t understand a lot about how proteins interact in our bodies.




Julie2

05-29-200601:37 PM

I am getting this done every 2 months. I got the orders from my primary physician. But my oncologist doesn't trust this at all. She wants me to stop it.

Julie

RESPONSE

It is good news that at least one of your 2 physicians is informed. Let’s get your oncologist factual information so he/she can make an informed decision. As I mentioned earlier, there is information about the Bayer Serum HER-2/neu Test including downloadable brochures on a new website called www.neunews.net. Perhaps you could print it for your oncologist or give them the website.






LovingDaughter

05-29-200602:15 PM

Could someone please explain what this test is? I haven't heard about it until now.






RESPONSE



The serum HER-2/neu test is a test that measures the amount HER-2/neu protein shed from the surface of normal cells and cancer cells. The normal blood value is <15 ng/ml. Anywhere from 30-80% of women with metastatic breast cancer can have an elevated serum HER-2/neu level (>15 ng/ml), which is reflective of them having HER-2/neu positive tumors.

The test has been cleared by the FDA for use in women with metastatic breast cancer and if the initial value is >15 ng/ml, these women can be monitored for changing levels. Increasing levels overtime reflect disease progression while decreasing levels can reflect response to therapy or disease progression.

Please go to the www.neunews.net for additonal information on the serum HER-2/neu

test.



Several studies have shown that serum HER-2/neu leves can be increased in early stage breast cancer but the test is not yet cleared to be safe and effective in early stage breast cancer. We are working on studies such as BCIRG 006 to submit to the FDA that measuring serum HER-2/neu earlier in breast cancer has clinical value. However, at present time the test is not cleared for such a use.

Cathya

05-29-200602:42 PM

There is a string Bayer Serum Test - Dr. Walter CarneyGo to this near the top of the her2group forum.

Cathy


Thanks for pointing that out.

jsattaw

05-29-200608:27 PM

My onc is unsure of the test as well -- similar to the Oncogene DX test in that they don't really know the prognostic value and how it "fits in" with other tests they do. Plus, I still believe they're biased to wait for symptoms to appear and then proceed with treatment.



RESPONSE



Unfortunately new tests and new drugs take a while to be understood. This is primarily due to oncologist being overwhelmed with new literature concerning test and drugs. If advocates and patients spend the time to understand new tests and new drugs they can then share that information with their oncologist I think the educational progress will help treatment.

Oncotype Dx is very different than the serum HER-2/neu test made by Oncogene Science and Bayer. The Oncotpye Dx test is performed on tumor tissue and is Not FDA cleared and predicts prognosis or the probability that the tumor will recur. Doctors treat patients regardless of their prognosis.

The serum HER-2/neu test measures a specific protein in blood.. It helps physicians see how patients are responding to therapy and to optimize therapy.

Traditionally, treatment is provided upon signs of symptoms or positive imaging results. In the future, I believe we will be able to image single proteins released by cancer cells and this will allow much earlier detection of cancer. However, how soon such a technique will be available, I don’t know.



I did provide the disk that was distributed in San Antonio to my onc and he said he would review it. Since I don't have mets, it's not approved for me and I haven't pushed to have the testing. I have not had a chance to ask whether he has ordered the tests for Stage IV patients. The test is cleared for the management and monitoring or patients with metastatic breast cancer. Cancer cells outside the breast are therefore metastatic.

Please keep us informed of the progress you are making with your oncologists.
RESPONSE


I'm looking forward to seeing some results from ASCO.

Did you see the results? If not let me know and we will get them to you.

I think Joe posted the Bayer press release about the results. Have you seen it?

Jill




chrisy

05-29-200609:23 PM

My docs aren't convinced


I have asked both of my oncs - my regular one and my second opinion doc at UCSF. Neither of them thinks this would be worthwhile and one poo poo'd it as only being recommended by the people who sell it. Clearly, there are people on this board who have found it useful - Gina comes to mind. However, the medical/oncology community clearly is not "on board" with the value of this test

I don't know if others are also encountering this resistance - my oncs don't really rely on tumor markers, either - so what did I expect!




Thanks - and good luck at ASCO! I look forward to your posts on this.



RESPONSE



As an example, CEA has been around for 20+ years and many physicians don’t trust it and no longer use it. In many cases, CEA has helped treat patients and in many others it has not, however, that is no reason not to use it for those who will benefit. As we know, no test is always 100% correct and no drug is 100% effective but that doesn’t stop their use for those who will benefit. We don’t expect all medical oncologists to agree with the serum HER-2/neu test. However, we do hope they will understand the importance of tracking women with HER-2/neu positive tumors by using the serum HER-2/neu test and that the test will help optimize treatment options. What the FDA did clear was a test that reflects disease progression when serum HER-2/neu values increased over the normal level (>15 ng/ml). As you can see with the pending approval of Tykerb, there will be alternative HER-2/neu directed therapies and we hope the test will be useful in that application as well as with hormone and chemotherapy. There have been several studies that show that pretreatment elevated levels of serum HER-2/neu are associated with poor outcome in some patients receiving hormone therapy.




kristen

05-30-2006 04:06 AM

Hi Christine,
I am on he BRCIG study and they take my blood for this test I assume, they don't mention it by name, but say they are testing it for HER2. I don't know if Bayer has a hand in this or not and if they are trying to find out if this test works on non met patients who have taken Herceptin for the year following chemo?
As a study participant, I do not get the results of these tests so I don't know any numbers and since it's labeled only for mets, I can't talk my onc into this one.
It would be intereting to know if they are involved with this and are trying to get it labeled for non met patients?

I also wonder, and maybe this is my chemo brain, I haven't watched the presentation since it first came out, but if they are finding out that 50% of met patients are HER2 somehow it has switched from original dx, I don't know why that is not a huge selling feature for them? Couldn't they just run this test rather then do some invasive testing to find out if a new tumor is HER2? Wouldn't the numbers correlate that a tumor would be HER2? Just an uneducated question? and it could be chemo/menopausal brain talking here. Sorry if it is....I am glad you are all going and representing us at ASCO. I am looking forward to seeing what will be posted from the meeting. Thank you all for everything that you do here. Safe Travels.



RESPONSE



FYI, BCIRG has 2 studies that are ongoing and Bayer Diagnostics is financially supporting both through an agreement with BCIRG and Dr. Slamon. The 2 studies are referred to as 006 and 007.

Study 006 is measuring serum HER-2/neu levels at periodic intervals in women who are receiving Herceptin and chemotherapy in the adjuvant setting.Depending on the results of the 006 clinical research, Bayer will decide on the value of seeking an FDA claim for the use of serum HER-2/neu in the adjuvant setting.

Study 007 is measuring HER-2/neu levels in metastatic breast cancer patients.






janet/FL

05-30-2006 09:06 AM

Two of my oncs and one research nurse poo pooed the idea of the test and would not order it, period. My third onc did say he would order it if I wanted it and would pay for it but as a stage one--there doesn't seem to be any reason for it. At least I can't figure out when I should ask for it. My current onc is for not testing until symptoms present saying it makes no difference in long term out come. I will need to find facts to dispute this if I want tests following the end of Herceptin in August.



RESPONSE



Knowing HER-2/neu status is very important since it helps doctors know if they should give Herceptin. The earlier Herceptin and chemotherapy can be given the better the clinical outcome. The adjuvant trials reported in the past few years have proven that.
Janet




Helen

05-30-2006 09:11 AM

I am having a problem convincing my onc to give me this test too. I gave him a copy of the CD. I am stage IV. He said he will not use this type of test in his practice because it is not part of a clinical trial. How do I convince him? He is the only oncologist in the city where I live. If I change, the other nearest one is 30 miles away and I am not even sure if he also uses this test.

Helen


Oncologist are extremely busy and the best thing all of us can do is to provide them with important educational information in small packets. . You should tell your docotor that the FDA cleared the serum HER-2/neu test for patients with metastatic breast cancer based on clinical trials data presented to FDA in 1999 and whichwas approved by the FDA in September 2000. Have them go to www.neunews.net

kat in the delta

05-30-200601:19 PM

kat in the delta


Christine,
Tell Dr. Carney that I gave my Onc the website last week, but it would help if HE would contact MY ONC personally. I will get my onc's address/ fax and send it to you privately. I don't know how many ONCs. have even heard about it. Like another person said, I don't think most oncs. like to have TESTS done on us--BUT I DO !!!! My son's French friend Chloe teaches tennis to a lady who has returned to Switzerland for treatments. Chloe is getting in touch with her to see if she knows about the test. Is it available in other countries ?? ((Chloe has graduated from U of MS with a BS degree in Marketing and returning to France to be certified in tennis.{job possibility?))





RESPONSE

My fax number is 617-492-8438.

Doctors are under a lot of pressure to keep costs down or reduce cost. Until they understand the value of the test, it will be an uphill battle.



The serum HER-2/neu test is available in Paris. Here is the email ( Rainer Neumann/BVRN/BV/DE/BAYER@BAYERNOTES@BAYER-GLOBAL) of my colleague in Germany who will tell you exactly where it is offered in Paris.




kat in the delta

05-30-200601:25 PM

kat in the delta


Christine,
Is there a CD on the Bayer Serum HER2 test you could send to us so we could give it to our ONCs?? I want to take the test. Could the local Hospital get the test ?? I know most dept. heads as my husband and another (of my 3) son are 2 of them. Please e-mail site, if so. Kat in the Delta


RESPONSE

Yes there is a CD available. Please let us know who to send it to and you can also go to this new website. www.neunews.net

StephN

05-31-2006 03:07 AM

Had the test


Hey Chris -
I am back from abroad and hope this my reply will get to you in time.

I had this test in February and had a good result of around 9, as I recall without looking it up.

When I first asked my med onc to order this test after San Antonio conference of 2004 he was not interested. This year he was - and he attends all these conferences so is "up" on new tests.

If I suspect any cancer activity I am sure he will order the test again.

Hope the word is getting out on this one and that the research will delve a little deeper into the question of possible use for early stagers.



RESPONSE



Perhaps you could encourage your oncologist to talk with other oncologists.




Barbara H.

05-31-200601:41 PM

Hi Christine,
My oncologist won't order it for me and I printed out the information from Joe for him. I don't think anyone at the Dana Farber is using it. Do you know why? Tumor markers are reliable for me and my onlcolgoist uses them. I hope that more information will be available at the meeting. He will be there but I understand it is a huge conference.
Thanks,
Barbara H.




RESPONSE

Please let us know who at the Dana Farber Cancer Institute you would like us to contact.

Christine

05-31-2006 09:05 PM

Thank you All


Thank you all for your many responses. I have been asked by the Bayer/Dako to participate in a discussion at ASCO. I will do my best to get more information and answers for your questions. In my own case, I will continue to take this test every 2 – 3 months, even if I am presently diagnosed as NED (No Evidence of Disease). I feel it is essential by any means to get the earliest possible indications from all tests available that works for you! I have been tested five times over the past ten months. Results are always around 8. Slight changes are normal as long as it does not go up steadily over 15. To me, this would mean it is time to get CAT or MRI scans of my body to rule out any progression. This test could alert us to get scanned. I don't have any reason to think I have more tumors except my brain is always under surveillance. Thank God I can continue to be free of all tumors.

Hugs,
Christine



Christine and members of the HER-2/neu Support: According to our studies approved by the FDA, a 20% change from one serum HER-2/neu test to the next is a significant change.



Christine, good luck and you are using the test as currently indicated, to monitor your disease and using it to help your doctor optimize your therapy.




kk1

06-01-2006 06:34 AM

Christine;

My Onc at UM Sylvestor routinely uses both the Her2 serum and now the CTC tests. I get them about every 10-12 weeks. So far everything has been within expected ranges. If we were to see a rise then we would do scans more frequently. While they remain low I get scans and Brain MRI only every 6-7 months.

My Onc. mentioned last week that he has found the tests extremely useful in many of his patients.

kk1

RESPONSE

Thank you for your information and please keep us up to date.




Lisa

06-01-2006 06:42 AM

Christine,

Like many others, my onc sees no value in it. I'm on continuous chemo (currently Xeloda) plus Herceptin and Zometa. He says, and I must agree, what is the real value of this test at this point. I'm already on Herceptin and to date there's no substitution, say if the test were high.

Love and light,

Lisa

RESPONSE

It is increasingly important to monitor your HER-2/neu level especially in light of the fact that Lapatinib (Tykerb) could very soon be an FDA-approved drug for all doctors to use as an alternative HER-2/neu-directed therapy.




StephN

06-01-200612:15 PM

Value of test


Lisa -
When we met with the team that has created and tested this test last Dec. in San Antonio, there were a few answers. But the concensus was that the best use of this test was to monitor stage IV patients who are beginning a new treatment to see if the number goes up or down at two weeks into that cycle, and continue the blood test to monitor success or failure of that or a new treatment. Dr. Julie Gralow mentioned starting a trial using the blood test in just this way.

The other recommended use of the test was as a way to monitor stage IV patients who are NED or close to NED. A rise in HER2 cells can indicate increasing tumor activity well in advance of the other tumor markers or detection of tumors by various scan methods.

In your case, it would be a good idea to see what Dr. Carney thinks about using this test. I would still think it could be useful as a way to monitor success of your treatment.



As StephN has pointed out, this test is useful in monitoring response or lack of response to therapy.




heblaj01

06-01-200606:36 PM

Christine,

Could you find out if a low reading the test could potentially help to discover that, while Herceptin is making HER-2 tumours regress, other HER-2 negative lesions are progressing (or not regressing) by comparing with other non selective existing markers?
If so, this would allow the onc to add other treatments to Herceptin at an oppotune time.


RESPONSE

Serum HER-2/neu is not a test indicated for truly HER-2/neu negative patients, however, it can be used to identify patients with serum HER-2/neu levels .>15 ng/ml HER-2/neu who are negative by IHC and FISH.

Cathya

06-13-2006 11:17 AM

Christine;

Is there any information to answer the questions posed on this thread. I am still trying very hard to get this test in Canada. Thanks

Cathy




Cathya

06-13-2006 12:05 PM

Christine;

I have just gotten off the phone from my contact at Dako Canada and he tells me that all of the documentation for the Canadian government has been given to Bayer Oncogene and they are the ones who are delaying this test being available in Canada. They want more publicity or whatever......it's really a catch 22 to me as my onc has written up the prescription for it but we can't get it so he won't be after it for others..... We also need a lab but the Dako guy said that if the lab here is set up Elissa (spelling? I think he means other of their tests..?) they should be able to do the test. So.....what response did you get from them and can you put any pressure on them for the Canadians on the site?

Cathy



RESPONSE

Unfortunately, this information is incorrect. We are trying very hard to find a way to offer the test in Canada, but due to policies of the Canadian government, we have not yet received permission to distribute the product in Canada. Bayer uses DAKO to distribute the product in Canada and we are working with DAKO to find a way to offer the test in Canada, but have not yet been successful. DAKO continues to try to find a solution




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[DeborahNC]

Thank you, Joe. I have emailed the contact provided on the DAKO site with my onc's info as recommended.

I appreciate having all the Q&A's posted!

[Ann]

Joe and Christine,

Thank you for the information and website address. I will be seeing my onocologist this next week and I plan on printing some of the information so that when I request the test, he can see the value of it.

Joe

Thank you so much for the response. I will continue to monitor the availability of the test in Canada and hope for good news soon. I so appreciate your attention to this important matter.

Cathy

[Cynthia]

Thank you to Dr. Carney for taking the time to respond personally to all of our questions and comments. Thanks to Joe and Christine, I had the great pleasure of meeting Dr. Carney and his colleagues at ASCO. It is so rare to meet a researcher who is willing to communicate directly with patients as Dr. Carney has done with all of us here. In addition to being an obviously brilliant man, he is a really nice and caring person.

Cynthia