# Afirma Gene Classifier Test (Im confused!!!)



## Denae (Jan 19, 2013)

Background:

So, I went to the doctor 2 months ago for a rash on my neck. When I went in they noticed a nodule on my thyroid (Right lobe). They told me to get an ultrasound and blood tests to rule out hyper/hypo thyroidism. All the blood test came back as normal and my TSH levels were normal. They did the ultrasound and found a nodule/goiter that measured about 2cm. They said it was concerning so I went to an Endo. I had blood test for antibodies done (hashimotos) and it came back normal so I dont have that. I also had the FNA done. I got the results yesterday and it said that the Cytopathology was "indeterminate" or "inconclusive" and was "classified as atypia of undetermined significance".

Now, normally I know they would recommend to still have thyroid removed/partially removed. But I also had the Afirma Gene Classifier test done. It is relatively new (the test) like the past couple of years. I did a lot of research on it and read the whole study that they did on it. They said it has 94-95% chance of being right. Here is an article explaining more about it: http://thyroid.about.com/od/cancergoiternodules/a/veracyte-afirma-thyroid-analysis-nodules_2.htm

They basically came up with this test to stop unnecessary surgeries for those whose test came back benign. Well, mine came back Benign. Which means according to what it says on my test results: "less that 6% of being malignant or suspicious for malignancy".

So, I am confused. My Endo. told me since I am 25 yrs. old I should just have the surgery and take it out and be on meds my whole life and deal with being hypothyroid. Which I would do if I knew my chances were high of it turning into cancer or if it were cancer. But if this test says its benign then I dont want to do a surgery and turn out it was for nothing. 

My doctor said if I dont have surgery to come back in 3 months with more TSH levels/blood tests and do another FNA to check again. I am leaning towards just doing that and monitoring that since my thyroid functioning is normal and its not causing any problems with breathing/swallowing.

I am still going to consult with a surgeon to get a second opinion like my Endo. recommended but I do not what to do honestly. I feel like I should take it out and get it over with but then part of me is saying there is a 95% chance its nothing and if I closely monitor it I can have surgery need be if it develops into something.

Thanks so much for your input and help!! i have noone to talk to about this stuff!


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## StormFinch (Nov 16, 2012)

Wow, tough decision Denae. :confused0033:

On what part of the lobe is the nodule located?

It might or might not necessitate an additional surgery, but there's also the possibility of what's called a Frozen Section. With that they do a surgical biopsy and then lab it, which takes about a week for results. However, if the frozen section and Afirma both agreed then you might feel a lot better about just hanging onto your thyroid and having it rechecked periodically.


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## jenny v (May 6, 2012)

I would definitely get a second opinion (and even a third, if you're still unsure). If you are truly feeling okay now and all of your labs look normal, it's a big step to take out part or all of your thyroid. Would your doctors be okay with monitoring it for 6 months or so and if it changes at all, then discuss removing it?


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## Denae (Jan 19, 2013)

StormFinch said:


> Wow, tough decision Denae. :confused0033:
> 
> On what part of the lobe is the nodule located?
> 
> It might or might not necessitate an additional surgery, but there's also the possibility of what's called a Frozen Section. With that they do a surgical biopsy and then lab it, which takes about a week for results. However, if the frozen section and Afirma both agreed then you might feel a lot better about just hanging onto your thyroid and having it rechecked periodically.


Its located on the Right lobe. In the middle portion of the right lobe to be exact. Yeah I dont think my endo explained everything to me very clearly. He basically told me to just go ahead and have the surgery "because I am young" whatever that means lol. He didn't even really go into the Gene Classifier test which I thought was odd he didnt mention it that often. He just looked at the cytopathology results. He has been in practice 30 years so I am sure he is used to doing things a certain way. maybe that is why with this new test he still just went with what he always says "if it is inconclusive just have the surgery...."

He told me they would take the part out with the nodule and then will tell right away if its malignant or not and then they would do a total thyroidectomy or just partial depending on results of that test (while im in surgery) so thats all I have been told, Thank you for your information because I had no idea you could do the frozen section thing so I will def. take a look at that! Thanks so much!


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## Denae (Jan 19, 2013)

jenny v said:


> I would definitely get a second opinion (and even a third, if you're still unsure). If you are truly feeling okay now and all of your labs look normal, it's a big step to take out part or all of your thyroid. Would your doctors be okay with monitoring it for 6 months or so and if it changes at all, then discuss removing it?


Yeah I have decided I am definitely going to get a second opinion. My endo recommended going to a surgeon but I think I might just go to another Endo for a second opinion first just to see if they are more familiar with the Afirma Gene test. I think he wanted to err on the side of caution but its my body and I havent even had kids yet or finished grad school so I need my hormones/energy!  I hope that a second opinion will clear it up for me. Thank you so much for your reply!


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## StormFinch (Nov 16, 2012)

Actually, if you can find one in your area try shooting for an endocrine surgeon. Mine does both endocrinology and oncology so he's well versed in the whole shebang.

I'm on my nook currently or I'd give you the link, but google the association of endocrine surgeons. They have a doctor finder.


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## Andros (Aug 26, 2009)

Denae said:


> Background:
> 
> So, I went to the doctor 2 months ago for a rash on my neck. When I went in they noticed a nodule on my thyroid (Right lobe). They told me to get an ultrasound and blood tests to rule out hyper/hypo thyroidism. All the blood test came back as normal and my TSH levels were normal. They did the ultrasound and found a nodule/goiter that measured about 2cm. They said it was concerning so I went to an Endo. I had blood test for antibodies done (hashimotos) and it came back normal so I dont have that. I also had the FNA done. I got the results yesterday and it said that the Cytopathology was "indeterminate" or "inconclusive" and was "classified as atypia of undetermined significance".
> 
> ...












Have you had Thyroglobulin and Thyroglobulin Ab run?


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## Octavia (Aug 1, 2011)

StormFinch said:


> It might or might not necessitate an additional surgery, but there's also the possibility of what's called a Frozen Section. With that they do a surgical biopsy and then lab it, which takes about a week for results. However, if the frozen section and Afirma both agreed then you might feel a lot better about just hanging onto your thyroid and having it rechecked periodically.


Maybe we're talking about two different things, but for my surgeon/hospital, the frozen section is immediate, during your surgery. They take a sample to the pathology lab to get a "quick read" to see if it's cancerous, then make a decision, in the middle of surgery, about whether to close you up with just a lobectomy, or take the entire thyroid. It is often wrong, so many surgeons don't trust it - false positives and false negatives. My frozen section showed benign, but my real pathology (which takes days) showed papillary cancer. So I had to have a second surgery a few weeks after the first one to have my remaining lobe removed.


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## crimebuff (May 25, 2012)

Denae said:


> Background:
> 
> So, I went to the doctor 2 months ago for a rash on my neck. When I went in they noticed a nodule on my thyroid (Right lobe). They told me to get an ultrasound and blood tests to rule out hyper/hypo thyroidism. All the blood test came back as normal and my TSH levels were normal. They did the ultrasound and found a nodule/goiter that measured about 2cm. They said it was concerning so I went to an Endo. I had blood test for antibodies done (hashimotos) and it came back normal so I dont have that. I also had the FNA done. I got the results yesterday and it said that the Cytopathology was "indeterminate" or "inconclusive" and was "classified as atypia of undetermined significance".
> 
> ...


I have experience with the Affirma test.8 years ago a nodule of 2 cm was found and FNA showed benign. Over time, it never grew but a doctor read the ultrasound incorrectly last year, thought it had grown and ordered a new FMA which came back "indeterminate" this time. Affirma did their test and said 50 per cent probability of cancer. Had the surgery, and lo and behold, it was cancer. The Affirma test is so accurate, if I were you I would not do anything yet. Keep watching it and have another test later on. If you go for a second opinion, make sure the doctor is familiar with the Affirma test as many doctors are not. Another option is to have the surgery but only on the side with the nodule.i would wait..the Affirma test is to prevent unnecessary surgery and yours seems like one of those, lucky for you!


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## Denae (Jan 19, 2013)

Andros said:


> Have you had Thyroglobulin and Thyroglobulin Ab run?


yes I had that done too and it all came back normal 

here are my TSH ranges:

TSH 0.87
T4 8.9
T3, TOTAL 102

Reference Range:
(for TSH)

0.40-4.50

I am confused about my TSH as well because my other friend who is a nurse said I am on "the high end of normal" at a .87 for my TSH (overall) Is this true? she said since its kind of high I should be on a low dose of armour/synthroid....but my Endo. never mentioned this at all!

I also just learned my BIological mom had Hypothyroidism. I was adopted so I didnt know that until the other day. Also my Half brother had a nodule/goiter and it turned out to be of no concern. He had it since he was a child....


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## Denae (Jan 19, 2013)

crimebuff said:


> I have experience with the Affirma test.8 years ago a nodule of 2 cm was found and FNA showed benign. Over time, it never grew but a doctor read the ultrasound incorrectly last year, thought it had grown and ordered a new FMA which came back "indeterminate" this time. Affirma did their test and said 50 per cent probability of cancer. Had the surgery, and lo and behold, it was cancer. The Affirma test is so accurate, if I were you I would not do anything yet. Keep watching it and have another test later on. If you go for a second opinion, make sure the doctor is familiar with the Affirma test as many doctors are not. Another option is to have the surgery but only on the side with the nodule.i would wait..the Affirma test is to prevent unnecessary surgery and yours seems like one of those, lucky for you!


Oh my gosh! Thank you so much for posting this! I seriously have been waiting and waiting for someone ANYONE to have experience with this dang test lol....I am so sorry you had to go thru your surgery but I am so glad you are doing okay now and the Afirma test helped you out! I have another appt on Feb. 11th with a surgeon at a cancer research university so I am PRAYING they have heard of the Afirma test. SO far I have had to tell the doctors what it means?! which is crazy to me but whatever...I just hope I can find someone else who has experience with this test  thanks so much for posting!!!


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## Sandbar (Nov 6, 2012)

I had an FNA for a nodule and my endo asked if I would give permission for the genetic test if need be and I said yes. He didn't give it a name but it sounds like the Affirma test from how he explained it to me - in my case it wasn't necessary though. Still if it were me in your position, absolutely since the Affirma test says it is unlikely to be cancer just let it be. You can always have regular ultrasounds to follow up on the nodule and get surgery later if you need to. Just take a look at the hypothyroid boards here and elsewhere and what people go through trying to get effective replacement dosages and types - you don't want to go into that world unless you have to. Just my two cents... Btw, I have eight, count 'em, eight nodules that have to be monitored every six months and as long they behave I'm letting them stay right where they are.


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## Denae (Jan 19, 2013)

Thank you Sandbar! I appreciate your opinion and advice very much! I totally would not even be considering surgery right now if it weren't for my Endo not explaining the gene classifier to me at all....If he wouldnt have told me what it was I wouldnt even be concerned about surgery at this point in my life..but I had to go home and research it all on my own and at that point I was already considering surgery you know? because my endo said to consider it. Now that I have heard from many on here (thank God) and from other family and friends I am going to monitor it and go back in 3 months to have the test done again. I dont want to prolong the inevitable but I really want to keep my thyroid as long as possible  thanks again :hugs:


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## CindiG (May 9, 2013)

crimebuff said:


> I have experience with the Affirma test.8 years ago a nodule of 2 cm was found and FNA showed benign. Over time, it never grew but a doctor read the ultrasound incorrectly last year, thought it had grown and ordered a new FMA which came back "indeterminate" this time. Affirma did their test and said 50 per cent probability of cancer. Had the surgery, and lo and behold, it was cancer. The Affirma test is so accurate, if I were you I would not do anything yet. Keep watching it and have another test later on. If you go for a second opinion, make sure the doctor is familiar with the Affirma test as many doctors are not. Another option is to have the surgery but only on the side with the nodule.i would wait..the Affirma test is to prevent unnecessary surgery and yours seems like one of those, lucky for you!


I have a lot of great important articles by many different endocrinologists written at different times for The American Thyroid Association's journal criticizing the Afirma test and how 48% (I'm sure it's much higher!) they misclassify benign nodules as suspicious! I would really like to post the articles on here but I don't know if the moderators will allow me to.

The other day I spoke to Barbara Rath Smith the executive director of The American Thyroid Association and she said she was going to email articles as files to download and she did. I asked her if I have permission to email and post these articles and she said yes,they are for the public.

A woman on the excellent health site Medhelp told me she had a 3cm. something nodule with a majority of Hurthle cells with normal thyroid blood tests and the Afirma test came back more than 40% suspicious so she had half her thyroid out and this nodule was benign! I also read on this Inspire site in their Thyroid Cancer Survivors Association forum,a woman had a 2cm indterminate nodule that everyone was concerned about and her Afirma test came out suspicious,and she had her thyroid removed,it turns out that the 2cm nodule was benign but they found tiny papillary cancers all under 5mm that weren't even seen on the ultrasound! She also said that her surgeon told her he's had five patients that had a suspicious result from the Afirma test,and then when their nodules were removed and tested they too were benign!

Yesterday endocrinologist Dr.Steven P.Hadak who co-authored one of these studies called me back and was very nice,he even had a patient waiting! He said this Afirma test is wrong half the time misclassifying benign nodules as suspicious,(I'm sure it's even more than half!) and I said this is not a good test,and he said I don't think it's a good test either!

Please click on this link,for some reason I can't cut and paste out the forum discussion. I just found *another* woman on this very board with a 1-1 and half cm solid hypoechoic nodule who had an inconclusive Fine Needle biopsy which was suspicious as a follicular neoplasm and mine is being called a follicular neoplasm with oncocytic (hurthle cell features) ,this woman had her FNA nodule sample tested by the veractye Afirma Test which is what I had done,the results came back telling her that her that their results on her FNA was highly suspicious and that because of this her endo told her she had an 80% chance of having thyroid cancer and so she had her thyroid out and found out it was benign!

http://www.thyroidboards.com/showthread.php?t=5283


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