Are you familar with these possible changes re: Mutation testing

Portal Forums Cancer Basics Oncology Economics/Industry/Policy Are you familar with these possible changes re: Mutation testing

This topic contains 9 replies, has 4 voices, and was last updated by Dr West Dr West 2 years, 9 months ago.

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January 31, 2015 at 1:16 pm  #1268325    

cards7up

https://www.change.org/p/us-fda-withdraw-proposed-ldt-regulations-these-could-limit-pt-access-to-therapies?recruiter=31872882&utm_source=share_petition&utm_medium=facebook&utm_campaign=autopublish&utm_term=des-lg-share_petition-no_msg&utm_content=ci_fb_share_title_text%3Ano_dm_l&fb_ref=Default


Stage IIIA adeno, dx 7/2010. SRS then chemo carbo/alimta 4x. NED as of 10/2011.
Local recurrence, surgery to remove LRL 8/29/13. 5.2cm involved pleura. Chemo carbo/alimta x3. NED

January 31, 2015 at 1:32 pm  #1268327    
catdander forum moderator
catdander forum moderator

EEK, interesting.

February 1, 2015 at 7:48 am  #1268337    

cards7up

Janine, anyway to get Dr. West or one of the other doctors to respond to this? Thanks!
Take care, Judy


Stage IIIA adeno, dx 7/2010. SRS then chemo carbo/alimta 4x. NED as of 10/2011.
Local recurrence, surgery to remove LRL 8/29/13. 5.2cm involved pleura. Chemo carbo/alimta x3. NED

February 1, 2015 at 11:34 am  #1268339    
catdander forum moderator
catdander forum moderator

Yes Judy, It may take a little bit especially on the weekend. We’re trying to give other faculty time to respond to posts so Dr. West isn’t left with all the lifting. ;) But if I get the jest of the article I think it’s a subject we will get thoughtful input.

February 1, 2015 at 8:22 pm  #1268342    
Dr West
Dr West

Honestly, I think this is a very complex situation and that there are MANY companies marketing tests of very sketchy quality that they market aggressively to patients despite having very little evidence to support it.

I am not in favor of having all government oversight be a referendum on very complex issues based on presentation of a very one-sided perspective that reflexively says that if it might possibly help one patient, nothing should be regulated, no matter whether there is a good chance of causing more harm than benefit.

-Dr. West

February 2, 2015 at 5:48 am  #1268344    

cards7up

I think having pre-aproved testing labs set up is one thing. Having a patient/doctor have to go to the FDA first to get the test site approved is ridiculous. Take care, Judy


Stage IIIA adeno, dx 7/2010. SRS then chemo carbo/alimta 4x. NED as of 10/2011.
Local recurrence, surgery to remove LRL 8/29/13. 5.2cm involved pleura. Chemo carbo/alimta x3. NED

February 2, 2015 at 1:31 pm  #1268348    
Dr Pennell
Dr Pennell

This is a very complicated issue and I see both sides’ arguments. On the one hand, I agree with Dr. West that some of the tests sold by private companies are NOT up to snuff and patients are likely being denied treatments (or led to the wrong treatments) by poorly designed and validated tests.

On the other hand, making every lab-developed test, which to be clear includes MOST of the molecular testing done on cancer patients’ tissue in the US today, go through the same rigorous validation necessary for FDA-approval of a companion diagnostic test would be a disaster. For example, the FDA-approved diagnostic like the Vysis FISH probes for ALK testing (that were approved along with Xalkori) is only approved on paraffin embedded tissue biopsies. This kind of test was in my opinion more of a research artifact designed to prove the drug worked than a test designed to allow accurate testing in real world patients. It is not approved for testing the most commonly available tumor tissue from lung cancer patients, namely needle biopsy smears (cytology).

At the Cleveland Clinic, we rigorously developed accurate testing for ALK on cytology specimens using the approved Vysis probes, and published this more than once. It works very well and is extremely reliable, and has allowed us to test essentially every new lung cancer patient. But, is this enough for FDA approval? Quite possibly not. If not, then we are held to only using the FDA approved test which is not useful for the majority of patients.

So, in sum I think a middle ground is necessary, which is to require some level of validation for lab developed tests but not to the extreme level for full FDA approval which is simply not feasible for most centers.


Nathan Pennell, MD
Associate Professor, Solid Tumor Oncology
Cleveland Clinic Taussig Cancer Center

Views expressed here represent my opinion, not those of GRACE or Cleveland Clinic Taussig Cancer Center. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

February 2, 2015 at 7:01 pm  #1268349    
Dr West
Dr West

To clarify, I share many of Dr. Pennell’s views here (and Judy’s).

I think the challenge is trying to create the right net to catch the bad tests but not inadvertently stifle lots of important innovation. I think the FDA approach is heavy handed and not ideal and that a middle ground would be helpful. We just don’t have that available yet. In the meantime, as I spend more time thinking about this, I think the right course may be to convey to the FDA that this measure is over-reaching and that it should be more limited or not pursued.

-Dr. West

February 3, 2015 at 8:13 am  #1268354    

cards7up

Dr. Pennell and Dr. West, thank you for sharing more of what most people’s concerns are about with this if it gets regulated by the FDA. Do they turn to oncologists like you and the types of labs/hospitals you use to do these types of tests to ask for opinions? Many are signing online petitions to stop this type of regulating.
Take care, Judy


Stage IIIA adeno, dx 7/2010. SRS then chemo carbo/alimta 4x. NED as of 10/2011.
Local recurrence, surgery to remove LRL 8/29/13. 5.2cm involved pleura. Chemo carbo/alimta x3. NED

February 3, 2015 at 5:47 pm  #1268358    
Dr West
Dr West

No, they absolutely don’t solicit opinions from docs in the field.

-Dr. West

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