MeSH they misclassify benign nodules as suspicious! The Affirma Xpression Atlas is based on RNA sequencing. I am also concerned about hormone replacement, would like some personnal comments on recovery from Lobectomy versus TT . The aim of this study was to determine the clinical performance of the GSC as compared with the GEC at one academic medical center. On cytologic evaluation 3.0% of the cases were non diagnostic (ND), 9% benign, 62% AUS, and 26% suspicious for neoplasm (SN). Thyroid nodules are commonly found on ultrasound of the neck and the evaluation of a thyroid nodule may include thyroid biopsy. I don't trust this new Afirma thyroid test for very good reasons. I know how frustrating, scary and expensive this whole process is.I am sorry that you are going through it!! Epub 2018 Apr 10. Advice needed please. However, I was not informed of this. I wanted to share my Thyroidectomy story because like most of you I was super scared and nervous about surgery but my surgery went great and I've had no complications. And at that appointment, she told me she was about to go on maternity leave, and wanted me to have surgery before her leave. It is illegal for auto mechanics to do work on our car without an estimate, or accountants, lawyers etc but doctors and medical facilities can just run us into BK without any regard. and I just found out that my Afirma test isn't being paid for by my insurance company on the grounds that its test is considered "experimental.". :-). But still my labs are all within normal range. He recently called me back and said that my criticism of the test is valid. Genes hold the information to build and maintain an organisms cells and pass genetic traits to offspring. So the jump from that mentality to that of, "oh, I can get cancer, too" has big a huge one for me. An important limitation of this study is that the authors did not examine the rate of noninvasive follicular variant papillary thyroid cancer in specimens that were not reported as suspicious by the GEC test. Qualifiers of atypia in the cytologic diagnosis of thyroid nodules are associated with different Afirma gene expression classifier results and clinical outcomes. A Indeterminate Suspicious (ROM ~50%) Negative NRAS:p.Q61R c. 182A>G TSHR:p.M453T c. 1358T>C ISTHMUS A UPPER MIDDLE LOWER RIGHT LEFT See Xpression Atlas results overview page for additional information . Did your Afirma results show calcification? I was told to monitor my nodules every couple years using ultra-sound and if they increased in size, they needed to have FNA done. It was .62cm by then. Most probably, a lot more lobectomies are going to be performed for indeterminate nodules since the level of certainty is going to drop. Epub 2020 Aug 6. Patients usually return home or to work after the biopsy without any ill effects. I could feel food getting lodged in my throat, and felt a pinch like a nerve at times, too. Molecular Markers: genes and microRNAs that are expressed in benign or cancerous cells. Afirma GSC (NOT GEC) 50% Suspicious Fayadosky Oct 30, 2018 10:56 AM (edited Nov 04) Results came back 50% Suspicious for FN (Follicular Neoplasm) with positive HRAS c.18HRAS c.182A>G (Q61R) Negative for BRAF, RET/ptc1 and ptc3 Any Insights? Afirma said NEGATIVE for BRAF and Meduliary but still assigned a classification of "Suspicious" with 40% chance of cancer. Surgical margins: negative for tumor (tumor is < 0.1cm from margin) Thyroid bloodwork normal. I tried to avoid it for 10 years I am 52 years old , I have a multinodular goiter with many, many , many nodules,the biggest on the left side 2.2 cm right side 2.6 all TSH test results are good , in fact , my thyroid is fonctioning perfectly well. Background: Mine did, and that can also be a sign of cancer. This site needs JavaScript to work properly. The Afirma test results came back Benign on left side and Suspicious 40% on the right side . The Afirma Genomic Sequencing Classifier (GSC) is used to rule out malignancy and reclassify cytologically indeterminate (Bethesda III or IV) nodules to molecularly benign or suspicious ( 5 ). Of the 164 GSC nodules, 29 (17.6%) underwent thyroid surgery. Genes hold the information to build and maintain an organisms cells and pass genetic traits to offspring. I called back and left them a message that was at home, to call me back. I understand that Afirma tends to have a lot of false positives, but it's supposed to be fairly accurate for negative results. I welcome your thoughts on my case. When the nurse called she couldn't even tell me results over he phone -- she said she didn't know them -- but set up an appointment for end of the following week -- another wait. BACKGROUND I have bumps on my head that come and go and are considered normal, and another cyst on my arm that I've had since I was eleven -- also normal. My doctor then sent me to an endocrinologist for a biopsy which came back with atypical but inconclusive results. I've read a lot about this test (both good and bad). result (eg, benign or suspicious) Public Comment. I'm looking for any and all help and/information you can share with me. Now, I will most probably undergo surgery, I requested only the right side be removed and they will have a pathologist look at it while I am under and then decide if they remove the whole thing. GEC's SE and SP among studies ranged from 78.0 to 100% and 7.7 to 51.7%, respectively. I've enjoyed good health for my whole life. The other side is that I had to have a 2nd biopsy done just to collect cells for AFIRMA. But it is saying that actual surgical results show that 40% "suspicion" turns out to send lots of people to surgery and then about 50% of the surgeries done yield results that show that the nodules were not cancerous at all. If benign = no surgery, IF suspicious or malignant = surgery. (And myself.) Home Patients Portal Clinical Thyroidology for the Public February 2020 Vol 13 Issue 2 p.13-14, CLINICAL THYROIDOLOGY FOR THE PUBLIC The current Afirma Genomic Sequencing Classifier (GSC) demonstrates improved specificity, suggesting more nodules will have a benign result (benign call rate [BCR]), but independent data are needed to confirm this in clinical practice. Right now my neck lymph nodes look good. The authors reported the following rates of final diagnoses for these specimens: 65% of cases had no cancer (ie. The mindset of medical doctors is to analyze the information at hand and see if anything changes that warrants getting more data or doing surgery.". Afirma GEC or GSC a gene-expression classifier that identifies biopsies as "benign" or "suspicious," and mir-THYtype an mRNA-based classifier test. The authors concluded that a GEC suspicious test result may include noninvasive follicular variant papillary thyroid cancer as well as classical papillary thyroid cancer. I went under a fna biopsy and got the results stating that there's are 2 malignant tumors one on each side of my thyroid, and one is suspicions of papillary adenocarcinoma, the other one is suspicions of malignancy. I'm ready for my next step. Sometimes, thyroid biopsy specimens are indeterminate, meaning that thyroid cancer cannot be definitively ruled in or out. Which if they used the YTD income they could clearly see that I qualified for a reduced billing. The surgeon was great. http://biotechstrategyblog.com/2012/06/veracyte- afirma-gene-expression-classifier-thyroid-cancer- diagnostic-test.html/ I'm sure that over the years as more people have this Afirma test done,there will be even more people posting on thyroid and general health boards about getting false "suspicious" results from it! Anyway, if these are to be become non-malignant, the rates of malignancy for the different Bethesda Categories are going to have to be adjusted downward. The Affirma Genomic Sequence Classifier (GSC) is based on DNA sequencing. My Endo thinks I should see a thyroid surgeon and my other doctor wants to repeat ultrasounds in 4 months, adopting a wait and see approach. I scheduled the surgery for June 3rd but now I'm apprehensive because I don't want to have surgery if there's a chance of this to be benign. The Afirma MTC may not be billed separately using an additional unit or procedure code. something nodule with a majority of Hurthle cells with normal thyroid blood tests and the Afirma test came back 40% suspicious,it grew even bigger in two years and was hypoechoic and vascular on the ultrasound like mine and she said this concerned her and the radiologist,she said (she said my nodule sounds a lot like hers except hers was bigger) so she had half her thyroid out and this nodule was benign! He also says that out of 61 follicular neoplasms that were benign the Afirma test misclassified 31 of them as suspicious. The results of the GEC are either read as suspicious for cancer or benign. Cytopathol. I just wrote that these are 25% of all thycas, but I have read just recently that the figure might be anywhere between 15-25% because there are varying standards for diagnosing these between different institutions. My surgeon and endocrinologist said no further treatment is needed but to continue observation. Mol Genet Genomic Med. Thanks so much! He said this Afirma test is wrong half the time misclassifying benign nodules as suspicious,(I'm sure it's even more than half!) Long-Term Outcomes of Thyroid Nodule AFIRMA GEC Testing and Literature Review: An Institutional Experience. Thyroid 29:11151124. The doctor uses a very thin needle to withdraw cells from the thyroid nodule. I am so new to all this that I don't know what this means. A thyroid nodule biopsy can be benign (normal), malignant (cancer) or indeterminate. The Afirma GSC is a next-generation genomic test that relies on RNA sequencing and advanced machine learning methodology to categorize tissue from cytologically indeterminate FNA biopsy as either benign or suspicious.2 Cancer cells frequently have mutations in these genes. Historically, most patients with indeterminate thyroid nodule biopsies were referred for surgery though most would ultimately not have thyroid cancer (around 75% or more would have an unnecessary surgery). 6. doi: 10.1002/mgg3.1288. 4. Afirma Gene Expression Classifier: a test for a group of molecular markers in thyroid biopsy specimens in order to determine the likelihood that a thyroid nodule is benign or cancerous. Follow-up of atypia and follicular lesions of undetermined significance in thyroid fine needle aspiration cytology. eCollection 2021 Nov 1. There was no follow up in 13% of cases and 87% were resected (50% lobectomies and 50% total thyroidectomies). 2017 May;125(5):313-322. doi: 10.1002/cncy.21827. I have since found several more women who had false Afirma test results and had surgery and their nodules were also benign! https://www.inspire.com/groups/thyca-thyroid-cancer-survivors-association/discussion/afirma-thyroid-analysis/. I appreciate any and all responses, and please do respond, I need as much information as I can get and I live by the saying, "you don't know what you don't know." Indeterminate thyroid biopsy: this happens a few atypical cells are seen but not enough to be abnormal (atypia of unknown significance (AUS) or follicular lesion of unknown significance (FLUS)) or when the diagnosis is a follicular or hurthle cell lesion. 2013 Dec;24(6):385-90. doi: 10.1111/cyt.12021. I called my husband before I even received the callback, and couldn't stop crying. It came back 99% that its cancer. Epub 2021 Jun 22. I am so glad to find this as reading everyone's story helps me feel not so aloneTHANK YOU! Thyroid nodules are very common, occurring in up to 50% of individuals. The Afirma Xpression Atlas for thyroid nodules and thyroid cancer metastases: Insights to inform clinical decisionmaking from a fineneedle aspiration sample Jeffrey F. Krane, MD, PhD,1 Edmund S. Cibas, MD,2 Mayumi Endo, MD,3 Ellen Marqusee, MD,4 Mimi I. Hu, MD,5 Christian E. Nasr, MD,6 Steven G. Waguespack, MD,5 Lori J. Wirth, MD,7 Papillary Thyroid Cancer: the most common type of thyroid cancer. I did not necessarily like that simplistic answer and I told him, you have nothing to compare it to, since he had not seen my past records. Overall malignancy rates were highest in the GSC group at 39%, compared to 20% and 22% in the no-molecular-testing and GEC groups, respectively (P = 0.0222) . Yesterday my surgeon told me that FNA Biopsy and Affirma are not reliable and said he would be surprised if the post op pathology shows the same findings. The original Afirma GSC validation study showed: 54% of ITNs return a benign Afirma GSC result (GSC-B) When categorized by the Afirma test as GSC-B, the risk of thyroid cancer is < 4% When categorized by the genomic test as suspicious (GSC-S), the risk of thyroid cancer is ~50% All thyroid nodules with a "suspicious" Afirma GEC result were investigated. I am still holding off on surgery for now. PMC 3) What do I need to know? I called and almost everyone has that risk if it is suspicious. Of the 16 cases of follicular variant papillary thyroid cancer, 14 of them were noninvasive follicular variant of papillary thyroid cancer (88%). -Male - Slightly Hypothyroid which began over the past year or so The Afirma gene sequencing classifier (GSC) performs better in indeterminate thyroid nodules than the Afirma gene expression classifier (GEC) BACKGROUND Thyroid nodules are very common, occurring in up to 50% of individuals. However the "suspicious" result of the Afirma GEC does not classify these indeterminate nodules further in determining appropriate management. Thyroid Fine Needle Aspiration Biopsy (FNAB): a simple procedure that is done in the doctors office to determine if a thyroid nodule is benign (non-cancerous) or cancer. Papillary thyroid cancer is the most common type of thyroid cancer. Endo M et al 2019 Afirma Gene Sequencing Classifier compared with Gene Expression Classifier in indeterminate thyroid nodules. 2021 Aug;31(8):1253-1263. doi: 10.1089/thy.2020.0969. The Afirma Genomic Sequencing Classifier (GSC) was developed and clinically validated to utilize genomic material obtained during the FNA to accurately identify benign nodules among those deemed cytologically indeterminate so that diagnostic surgery can be avoided. I also recently found *another* article written by an endocrine surgeon Sam Wiseman from the Department of Surgery ,St.Paul's Hospital University Of British Columbia for the site Gland Surgery where he also points out real concerns that half of patients(as I said I know it's more,from all of the people I have found posting on thyroid boards) with benign nodules wrongly classified as "suspicious" by the Afirma test are getting unnecessary thyroid surgery because this Afirma result influenced a lot of endocrinologists and their patients to have the thyroid surgery! Cancer Cytopathol. Thyroseq v3, Afirma GSC, and microRNA Panels Versus Previous Molecular Tests in the Preoperative Diagnosis of Indeterminate Thyroid Nodules: A Systematic Review and Meta-Analysis. Indeterminate Thyroid Biopsy: this happens a few atypical cells are seen but not enough to be abnormal (atypia of unknown significance (AUS) or follicular lesion of unknown significance (FLUS)) or when the diagnosis is a follicular or hurthle cell lesion. Sometimes you only hear the bad stories and not the good so I wanted to share mine. Once you go down the hole, there are no good statistics to guide you in making rational decisions in an irrational area of medicine - AND as you know, no decisions in medicine in even cut and dried cases are so simple as to have no opposing point of view. Negative for BRAF, RET/ptc1 and ptc3 So, in 2014, Thanksgiving was about telling them there was something going on. Molecular testing for indeterminate thyroid nodules: Performance of the Afirma gene expression classifier and ThyroSeq panel. Would you like email updates of new search results? However, FVPTC is currently classified as a type of "papillary" carcinoma, so the rate of diagnosis is also going to fall pretty substantially. That was a hard Thanksgiving. Here member santef1 says she had a 2cm nodule that came as suspicious from the Afirma test but after surgery that nodule was found to be benign but as with what happened to so many people,they found several micro pap cancers not seen on the ultrasound. Lastly I do 25mcg of levothyroxine once a day for Hypothyroidism, it was prescribed based on lab results, not on how I was feeling. Hi, In May 2013 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 am wondering if anybody can comment on whether my case described below is considered to be reclassified according to the recently released guidelines. Then in December 2014 I thought to have it checked again, with the same results although this time I had it send for the Afirma testing which I was told is more accurate test for cancer. Rationale: Crosswalk to 81545 ($3,600) 81545 describes the original Afirma classifier; when . At least as accurate as FNA, or that was my understanding. Awaiting pathology. Third, I have no history of thyroid cancer (or any cancer) in my family. The Afirma GEC is a microarray-based molecular test that uses a machine learning-derived classification algorithm to further classify indeterminate thyroid nodules into benign and suspicious categories. Christmas got in the way, so January 22 is my date. Thyroid fine needle aspiration biopsy: a simple procedure that is done in the doctors office to determine if a thyroid nodule is benign (non-cancerous) or cancer. The third biopsy was sent for genetic testing which came back as suspicious. Forth, I have absolutely no symptoms and feel fine. He wisely advised that I need a thyroid ultrasound which revealed the nodule had grown to 2.2cm. 3.) Conclusion: 1). http://onlinelibrary.wiley.com/doi/10.1002/cncy.21455/full. The doctor uses a very thin needle to withdraw cells from the thyroid nodule. I had another biopsy which came back showing "Atypical cells". Any Insights? 5) What are your thoughts on these results? I was just feeling so much weight and defeated as a mother of four small children..three biological and one adopted in 2012..could not phantom the idea of not being there for my kids esp. I can learn to live healthier, and to appreciate each day, and to love and support more readily. Nevertheless, I am reluctant to just proceed particularly for the following reasons: o The Afirma MTC testing must be billed as part of the Afirma GSC. You started down the rabbit hole by focusing on your thyroid gland for no good reason, since the melanoma is not related to anything regarding your asymptomatic thyroid. Thyroid cancer support group and discussion community. Later that week I received a call telling me it was suspicious and was referred to an ENT which I saw yesterday. FOIA Now having dodged a few close bullets, I was like wobble head to my new endo's treatment plan which included 100 mci RAI though after reading my path report that I may be at little higher risk with "variant" than most others. The pathology database was searched for all thyroid nodules with Afirma test results over a three year period, 2013-2015. If all nonsurgical GEC benign cases were actually benign, when evaluating the cases that had surgery, the chance that a GEC suspicious nodule was actually cancer was 33.3% and the chance that a GEC benign nodule was actually benign at surgery was 98.2%. The PPV was 50% among GSC suspicious nodules when a variant or fusions was identified, compared with 44% among GSC suspicious nodules when no variant or fusion was identified (p = 0.77 [2]). I am very athletic , very healthy and happy ,don't want to give up any of that !!! The Afirma Genomic Sequencing Classifier (GSC) result was "Suspicious," but the usual orange color (representing ~50% risk of malignancy) of this result is replaced with gray, foreshadowing that . I don't want to jump the gun, and will wait to hear what the new doctor says. At this point, I was exasperated by all of the running around, but fine. official website and that any information you provide is encrypted Found an endocrinologist who is willing to work with me on some more testing. https://www.inspire.com/groups/thyca-thyroid-cancer-survivors-association/discussion/genetic-test-two-different-results/reply/6888430/?msg_activity=reply_posted. BTW, I'm about to turn 50 and I have no thyroid issues other than this. This large study demonstrates that almost one-half of Bethesda III/IV Afirma GSC suspicious and most Bethesda V/VI nodules had at least 1 genomic variant or fusion identified, which may optimize personalized treatment decisions. I know, that is still pricey but seems cheap compared to $6,000. Each of my pre-surgical tests are pointing more and more in the wrong direction. Abigail. For the past year I've been seeing functional medicine doctors to see if I could shrink my nodules with diet and nutrition but when I got the positive Afirma test and the biggest nodule 3cm kept growing I finally decided to have surgery, which I had last Thursday. I don't think the reclassification was mentioned specifically in the WSJ article. Accessibility I have 1.6 cm nodule on my right lobe. Thyroid 2016;26:911-5. A publication of the American Thyroid Association, Summaries for the Public from recent articles in Clinical Thyroidology, Table of Contents | PDF File for Saving and Printing, THYROID NODULES But that's a personal issue I'll have to work out in time. Seeking a second opinion I went to a leading hospital. And the 3rd test was Afirma which came back "suspicious". Bethesda, MD 20894, Web Policies Afirma BRAF V600E o Afirma BRAF testing may be considered for either GSC or FNA suspicious or malignant results. I heard about the Afirma analysis , spent $5000 on the test and the results are even more confusing !! Results: Afirma result was suspicious in 69 cases. So I gather if I am reading what you reported correctly, your case is another false NEGATIVE for the Afirma test? The other tested indeterminate, follicular atypia, cannot rule out follicular neoplasm. In my opinion, and my surgeons, I think FNA and Affirma are only good tools if you have positive results. Patients usually return home or to work after the biopsy without any ill effects. After some research of my own, I decided to leave it. On surgical resection 82% were benign, with 45% follicular adenoma (FA), and 37% nodular goiter (NG). Largest is 2.3(previously 1.8cm in 2014) different test center though. I don't know if I'm speaking too soon, but the pain isn't as bad as I thought it would be. 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! There was no follow up in 13% of cases and 87% were resected (50% lobectomies and 50% total thyroidectomies). 85% were benign. I'm not sure what the exact terminology is going to be. Follicular and hurthle cells are normal cells found in the thyroid. Neither will talk to the other. After hearing this, I felt a huge kick in my gut and also stupid for getting a second opinion for a fine needle biopsy though I'd ended up with an endo, who wrote articles on the subject. The cells need to be "fresh." Thanks. It seems like with every ultrasound, some new suspicious characteristic pops up.

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