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Alert Number 101

IgVH Test, Quest, Ohio State

Date: June 21, 2005

It really pays to get the details right, especially when listening to your doctor and then reporting the conversation to the wider patient population. A misconstrued or misreported attribution to experts can cause a lot of worry and aggravation.

There has been a recent post on the ACOR with comments attributed to Dr. Thomas Lin (a colleague of Dr. John Byrd of Ohio State), to the effect that he and his colleagues do not believe IgVH gene mutation test can be done accurately or reproducibly in the U.S, and that Quest’s testing is suspect because it is a commercial lab. The fallback option suggested in a second post on the same site was that blood samples be sent to the U.K for IgVH testing.

CLL Topics and Quest Diagnostics worked hard expediting the prognostic test packages. I was concerned with this question regarding their ability to do the test right. Attached below is my correspondence with Drs. Byrd and Lin. Dr. Lin was out of town, but Dr. Byrd was kind enough to respond right away. As you can see, not only does Dr. Byrd agree IgVH gene mutation status is an important prognostic indicator and one that can be done with accuracy and reproducibility in the U.S.A , he agrees Quest Diagnostics is fully qualified to provide this test. Dr. Byrd is copied on this Topics Alert, as is Dr. Albitar of Quest.

I fully agree getting IgVH gene mutation testing in the U.K is a good and viable option for our British and EU patients.

Be well,

Chaya
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Correspondence

Dear Dr. Byrd and Dr. Lin:

A couple of recent posts on an internet CLL chat room caused me concern. The post (by one of Dr. Thomas Lin’s patients, I believe), contains a quotation attributed to Dr. Lin and supposedly reflecting the views of the entire James Cancer Center, Ohio State University. It suggests that you and your colleagues do not believe IgVH gene mutation status can be done reproducibly in the U.S.A, and furthermore, the test as it is done at Quest Diagnostics is tainted because it is done by a commercial outfit. A second post suggested the fall back option is to send blood samples to the U.K. for IgVH testing.

You might be aware, as a result of negotiations with our patient group www.clltopics.org Quest Diagnostics now offers a set of prognostic and monitoring packages for CLL patients. You can review the details of the four packages offered by clicking on the link Prognostic and Monitoring Test Packages. While broad consensus has emerged among CLL experts on the value of these prognostic tests, up to now none of the large commercial testing laboratories offered the whole package of tests, most especially the crucial IgVH gene mutation status test.

No doubt many of these test protocols will be further modified over time, especially the ZAP-70 test. New tests may be added, and some of the existing ones dropped as we learn more about the different flavors of CLL. This is work in progress. However, it is my impression that there is not much disagreement on the usefulness of the IgVH gene mutation status as a strong prognostic indicator. Not all CLL patients have the luxury of visiting one of the CLL expert centers, and frankly, sending blood samples from the U.S. to the U.K for testing is impractical. Getting biologic samples such as blood across international borders is no easy task in today’s security environment. I doubt any of our healthcare providers would cover the charges of a lab test done in the U.K., and getting local oncologists to provide prescription for such a test would be no small task.

On the other hand, Quest Diagnostics is the largest testing lab in the U.S.A., with blood draw station coverage across the country and established contracts with all of the major healthcare insurance companies. We negotiated a very competitive price for the packages, much less expensive than getting each of the tests done piece meal. The testing is done at their California lab, under the expert guidance of Dr. Maher Albitar. I do not believe I need to introduce Dr. Albitar to you. Our experience in working with Quest has been positive across the board. Where there have been start-up snafus, Quest has bent over backwards in fixing them.

The comments attributed to Dr. Lin worry me, but perhaps they are not accurately reported. Ohio State is an important CLL expert center, and both of you are very influential opinion leaders in the field of modern prognostic testing. Patients face huge road blocks in getting these tests, many local oncologists who do not keep up with the latest literature still drag their feet in ordering these tests. Insurance companies often need only a fig leaf excuse to refuse coverage, and the last thing we want is to give them more ammunition! Your comments taken out of context may be construed as grounds for refusing coverage. At the very least, they confuse newly diagnosed patients looking for guidance.

I hope you agree that living as we do in an imperfect world, having access to the prognostic test packages offered by Quest Diagnostics is a good thing for patients. We request your help in resolving this little controversy. I will be happy to exchange emails or chat with either of you on the phone to answer any questions you may have. Thank you for your help.

Best regards,

Chaya Venkat
CLL Topics
___________

Chaya:

Thanks for your note.

I do believe that IgVH mutational status is a very important and reproducible prognostic factor.

I talked with Maher Albitar not to long ago, Quest labs is well qualified for providing IgVH mutational analysis, as their assay is CAPI approved. The price that Quest is charging for doing the IgVH gene mutation test is very reasonable, and provides a good option for patients. When assays are discussed with patients, it is important that the testing lab is CAPI approved, as Quest is. If in future other CAPI approved companies bring up to speed their ability to do IgVH mutational status with appropriate validation, they would also be acceptable.

With respect to ZAP-70, I do not believe that the reproducibility details on this test are sufficiently worked out to justify doing this outside of research. I am sure this is what Dr. Lin was referring to, the lack of reproducibility in testing for ZAP-70, not the IgVH gene mutation test. I see many patients who come to clinic with an uninterpretable ZAP-70 reports. We need refinement on how ZAP-70 measurement is done. Interphase FISH cytogenetics are also important for risk stratification. I am happy to discuss this with you. You have my permission to publish this response on your website.

Regards

John Byrd

John C. Byrd M.D.
Associate Professor of Medicine and Medicinal Chemistry
D. Warren Brown Professor in Leukemia Research
Director of Hematologic Malignancies
Division of Hematology-Oncology.
The Arthur James Comprehensive Cancer Center
B302 Starling Loving Hall
320 West 10th Avenue
Columbus, Ohio 43210
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