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The Afirma MTC may not be billed separately using an additional unit or procedure code. The doctor uses a very thin needle to withdraw cells from the thyroid nodule. Nevertheless, I am reluctant to just proceed particularly for the following reasons: But, I am concerned about the report I just received. Additionally, there is an increase in the benign call rate with GSC, which in this study decreased surgical interventions by 68%. The Afirma Xpression Atlas for thyroid nodules and thyroid cancer Thyroid nodule molecular profiling: The clinical utility of Afirma I had a biopsy for 4 nodules 2 mos ago. t=5283[/url]. WHAT ARE THE IMPLICATIONS OF THIS STUDY? Since then, I've had yearly scans (ultrasounds) and two biopsies, both came back negative. 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 ). With these genetic tests, patients and physicians have more information to feel confident about avoiding surgery or pursuing it based on the test results. A thyroid nodule biopsy can be benign (normal), malignant (cancer) or indeterminate. result (eg, benign or suspicious) Public Comment. Third, I have no history of thyroid cancer (or any cancer) in my family. The result of this 2.1 cm Bethesda IV nodule A is Arma GSC Benign, which suggests a low risk of cancer at approximately 4%. Thyroid cancer support group and discussion community. 2021 Oct 7;5(11):bvab148. 3) What do I need to know? Ultrasound reports unfortunately not very informative other than size. -38yrs old Results: The biopsy (Afirma) was indeterminate with GSC suspicious with a 50% ROM. The Afirma gene sequencing classifier (GSC) performs better in The Afirma Xpression Atlas for thyroid nodules and thyroid cancer Suspicious readings of the Afirma gene-expression classifier include some noninvasive encapsulated follicular variant of papillary thyroid carcinomas BACKGROUND Thyroid nodules are commonly found on ultrasound of the neck and the evaluation of a thyroid nodule may include thyroid biopsy. Part 3: Afirma genetic testing for thyroid cancer - Running with a In my opinion, and my surgeons, I think FNA and Affirma are only good tools if you have positive results. Background: I heard about the Afirma analysis , spent $5000 on the test and the results are even more confusing !! I am scheduled to have a TT on March 9th and I wish I felt a little better about my decision. He recently emailed me back and said,as we discusssed on the phone,he agrees with many of my concerns about the Afirma test. Several thyroid nodules. Afirma Genomic Sequencing Classifier and Xpression Atlas Molecular 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! Thus, 54 NIFTP cases were established, all with a suspicious Afirma GEC result. My oldest daughter has a friend who has survived thyroid cancer, and SHE was sure to tell ME about that. Of the 164 GSC nodules, 29 (17.6%) underwent thyroid surgery. The other approach to molecular diagnosis of thyroid cancer is the measurement of oncogenes such as BRAF on FNA to make a positive diagnosis of thyroid cancer in cytologically indeterminate FNA biopsies. Indeterminate thyroid nodules in the era of molecular genomics. So now I feel I have no choice to take it out (the nodule also grew .5 cm since the Aug test). I'm a foodie who has always struggled with weight, but I also exercise so I'm always just plump but in otherwise decent health. On cytologic evaluation 3.0% of the cases were non diagnostic (ND), 9% benign, 62% AUS, and 26% suspicious for neoplasm (SN). More than one doctor has told me I should just have surgery, at least half the thyroid, maybe the whole thing. 2017;45:308-311. 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! The Afirma Genomic Sequencing Classifier (GSC) provides physicians with a comprehensive solution for a complex landscape in thyroid cancer diagnosis and individualization of care. Careers. This site needs JavaScript to work properly. Epub 2020 Mar 17. I hadn't told my two college-age daughters about the series of more and more concerning doctor's visits, but knew I couldn't get through a long day with them at home without showing my emotions. Performance of Afirma Gene Sequencing Classifier versus - ScienceDirect Thanks for chiming in. eCollection 2021. The aggressive one wants to cover his ass in the tiny chance you have an aggressive thyroid cancer, and the wait and see one is playing the odds that there is nothing to worry about, and that unneeded surgery has risks that are higher than the benefits in your case. Here is what the Affirma test disclaimer said: Benign: Preformance characteristics not defined for nodules less than 1 cm diameter. However, its relatively low positive predictive value (PPV) limited its use as a classifier for patients with suspicious results. Our offering enables physicians to answer multiple clinical questions for their thyroid patients using a single, minimally invasive fine needle aspiration (FNA) sample. Should I be treating this as a Hurthle Cell Lesion, or should I just relax. The oncogene molecular method misses cancers that do not express the oncogenes tested,but has the advantage of having a much lower rate of false positives as compared with the GEC method,assuming that "suspicious" is positive. Which means I would still be paying this amount to the hospital if I didn't pay it to Affirma. I almost want to cancel the surgery. Follicular and hurthle cells are normal cells found in the thyroid. The good news is that if your insurance refuses to pay for the test, then you will only have to pay 300.00 out of pocket. Unable to load your collection due to an error, Unable to load your delegates due to an error. No parathyroid tissue identified. Am I being reasonable? No lymphovascular invasion is identified. Please let me know what you think. Bugs me. I'm shocked that my voice is still completely in tact. Genes: a molecular unit of heredity of a living organism. Largest is 2.3(previously 1.8cm in 2014) different test center though. The results were suspicious of papillary cancer, but not conclusive. The authors concluded that a GEC suspicious test result may include noninvasive follicular variant papillary thyroid cancer as well as classical papillary thyroid cancer. 6. Found an endocrinologist who is willing to work with me on some more testing. :-). Nishino M, Mateo R, Kilim H, Feldman A, Elliott A, Shen C, Hasselgren PO, Wang H, Hartzband P, Hennessey JV. I was told the only way to find out for sure is to have half my thyroid removed. What do I do? The Afirma Xpression Atlas for thyroid nodules and thyroid cancer 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 Follicular and hurthle cells are normal cells found in the thyroid. That didn't sit well with me. Personally, I think getting the AFIRMA test done is a good thing. Thyroid. Hello. These gene patterns are better at ruling out thyroid cancer in an indeterminate nodule than confirming cancer. I am hesitant to go to surgery with the 30% cancer chance without more information. Afirma GSC(NOT GEC) 50% Suspicious - Thyroid cancer - Inspire We had a long talk and discussed more conservative options, like a partial thyroidectomy, but no rush. Afirma; FNA; cytology; thyroid nodules. I'm curious, if you had similar biopsy results and had surgery, was your final path malignant or not? 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. However, the interesting twist was that cancer was not detected on the nodules being monitored, there was a little sucker hidden behind all these years according to my surgeon and this was why the pathologist at my local hosp could not come up with definitive conclusion as he/she was only focused on the biopsied nodules:( False Positives. Meanwhile I read a recent WSJ article about patients with ACTUAL thyroid cancer being offered a wait and see approach as there are so many issues after surgery--not just discomfort issues like fatigue, weight gain and so forth but also secondary cancers. This occurs in 1520% of biopsies and often results in the need for surgery to remove the nodule. Methods: 2017 May;125(5):313-322. doi: 10.1002/cncy.21827. This all new to me and I have a lot to learn. The moment that I've been so nervous about finally came yesterday. They did not address that issue in their letter, just my income. On May 8th endocrinologist Dr.Steven P.Hadak who with Dr. David S. Rosenthal co-authored one of these studies for The American Thyroid Association's Clinical Affairs Committee called,Information For Clinician's:Commercially Available Molecular Diagnosis Testing In The Evaluation Of Thyroid Nodule Fine-Needle Aspiration Specimens called me back and was very nice,he even had a patient waiting! 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. BACKGROUND Thyroid nodules are very common, occurring in up to 50% of individuals. the nodule was only 1.5 cm and I really had no concerning symptoms. I called back and left them a message that was at home, to call me back. 2021 Aug;31(8):1253-1263. doi: 10.1089/thy.2020.0969. At the end of his great article in the journal Clinical Thyroidology August 2012 criticizing the inaccuracies and unreliabilities of the Afirma test, endocrinologist of 50 years Dr.Jerome Hershman says, Currently the Veracyte Affirma GEC method "retails" for 3,350 plus 300 for cytopathology. I did not get to go under the knife for my TT til this past March. I don't know if I'm speaking too soon, but the pain isn't as bad as I thought it would be. Silaghi CA, Lozovanu V, Georgescu CE, Georgescu RD, Susman S, Nsui BA, Dobrean A, Silaghi H. Front Endocrinol (Lausanne). 1. My expensive, unsolicited, Afirma test results came back as negativegood thing I had already had my TT before I received the results; I have stage III pap/follicular thyca. He later called and said he was sending me for a biopsy. I agree that you should have been consulted for the genetic test!! 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. 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. I'm afraid I feel ok now then all of a sudden will begin feeling horrible. The Afirma GSC is designed to help clinicians manage these patients. 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. The original Afirma Xpression Atlas (XA) panel reported on 761 genomic variants and 130 fusion pairs from 511 genes ( 6 ). Don't want to gain weight or feel less optimal then I am now. Results: Afirma result was suspicious in 69 cases. Please, I am looking for any and all thoughts. The Affirma Genomic Sequence Classifier (GSC) is based on DNA sequencing. Here n this 2014 discussion member Olivia-T who was 69 when she posted this and had hurthle cell neoplasm that tripled in size in 10 months,and got a 40% suspicious from the Afirma test,and did post a follow up that did turn out to have thyroid cancer,says here that her oncologist said that her last two patients who had surgery also because of the 40% suspicious for cancer DNA test turned out to have benign tumors. Afirma Genomic Sequencing Classifier and Xpression Atlas - PubMed It was .62cm by then. Thyroid 2016;26:911-5. 2016 Jul;26(7):911-5. doi: 10.1089/thy.2015.0644. 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. How "suspicious" is that nodule? Review of "suspicious" Afirma gene 4. I've been battling hypothyroidism and suspicious thyroid nodules for 4 years. . MON-LB88 Positive Predictive Value of TP53 Variants - Oxford Academic For nodules determined to be GSC Suspicious or with a cytopathology diagnosis of Bethesda V or VI, physicians ordered XA by checking a box. I'm now 3 days post op and other than some difficulty swallowing and talking loud, I'm feeling great. The Afirma MTC may not be billed separately using an additional unit or procedure code. Example of an Afirma patient report of a hypothetical 1.5 cm thyroid Any Insights? But, I'm also tired of living with the uncertainty and semi-annual nerve sessions after each ultrasound. I know how frustrating, scary and expensive this whole process is.I am sorry that you are going through it!! May 7 endocrinologist Dr.Bryan Mclver,one of the authors of the article from September 2012 in The American Thyroid Association's Journal called,An Independent Study Of A Gene Expression Classifier (Afirma) In The Evaluation Of Cytologically Indeterminate Thyroid Nodules Initial Report and he used to work at The Mayo Clinic,(he now works at The Moffit Cancer Center called me back. Later that week I received a call telling me it was suspicious and was referred to an ENT which I saw yesterday. 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! My radiologist determined that the smallest one had follicular cancer cells in her description but called it indetermined. Repeat Fine Needle Aspiration Cytology Refines the Selection of Thyroid Nodules for Afirma Gene Expression Classifier Testing. 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. Background: The Afirma Gene Expression Classifier (GEC) has been used to further characterize cytologically indeterminate (cyto-I) thyroid nodules into either benign or suspicious categories. 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. GEC's SE and SP among studies ranged from 78.0 to 100% and 7.7 to 51.7%, respectively. for my adopted daughter as she's already lost her bio-parents and thus my husband and I became her new parents.I've stayed like zombie while awaited my total neck ultrasound results and they came back CLEAR any cancer spreading to lymph nodes..yey! Thyroid. PDF Lab Management Guidelines V1.0.2020 Afirma Thyroid Cancer - eviCore Hello, He recently called me back and said that my criticism of the test is valid. ThyCa: Thyroid Cancer Survivors' Association, Inc. 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. Epub 2017 Feb 2. The Afirma Genomic Sequencing Classifier (GSC) (Veracyte, San Francisco, CA) is a cancer rule-out test that partners whole transcriptome RNA sequencing with machine learning to categorize nodules as benign or suspicious. I've read a lot about this test (both good and bad). I can learn to live healthier, and to appreciate each day, and to love and support more readily. The rate of malignancy in nodules suspicious for neoplasm (SN) on cytology interpretation was 31.2% (5/16). doi: 10.1002/mgg3.1288. I am also concerned about hormone replacement, would like some personnal comments on recovery from Lobectomy versus TT . For some reason, my long time best friend is one of the least supportive in all of this. I do not have calcifications but all 4 nodules are solid, hypoechoic and vascular. I was informed in August of 2013 after a FNA that one of my nodules was suspicious and the recommendation was a TT. Thyroid nodule biopsies are used to identify if a nodule is cancerous or determine the risk that a thyroid nodule may be cancerous. Competition Heats Up With Latest Tests for Thyroid Nodules Thanks again, Ok so this is all brand new to me so please bear with me. I am so new to all this that I don't know what this means. Endo M et al 2019 Afirma Gene Sequencing Classifier compared with Gene Expression Classifier in indeterminate thyroid nodules. Patients usually return home or to work after the biopsy without any ill effects. Afirma BRAF V600E o Afirma BRAF testing may be considered for either GSC or FNA suspicious or malignant results. Still, I can see my nodule on one side and don't want to risk having cancer in my body, so I was ready to set up the surgery as soon as possible. It mentions possible microcalcification, which has never come up before. At least 1 genomic alteration was identified by the expanded Afirma XA panel in 70% of medullary thyroid carcinoma classifier-positive FNAs, 44% of Bethesda III or IV Afirma GSC suspicious FNAs, 64% of Bethesda V FNAs, and 87% of Bethesda VI FNAs. There are four types of FVPTV: encapsulated with invasion, encapsulated without invasion, unencapsulated non-invasive and unencapsulated and invasive into the surrounding parenchyma of the gland. My surgeon and endocrinologist said no further treatment is needed but to continue observation. I called and almost everyone has that risk if it is suspicious. o The Afirma MTC testing must be billed as part of the Afirma GSC. A. Tumor is partially encapsulated with no capsular invasion or extrathyroidal extension identified. THE FULL ARTICLE TITLE: Is one easier to recover from ? Papillary thyroid carcinoma, Follicular Variant, 2.1 cm in greatest dimension, present in mid to lowe pole, woth prior FNA site changes. Did your Afirma results show calcification? I pointed out to them that since the nodule tested was less than 1cm the radiologist should not have sent it and they should not have tested it. The Afirma GSC is a cancer rule-out test with a high negative predictive value so that cytologically indeterminate (Bethesda III/IV)2thyroid nodules with an Afirma GSC benign result can be considered for clinical observation in lieu of diagnostic surgical resection (Fig. Follow-up of atypia and follicular lesions of undetermined significance in thyroid fine needle aspiration cytology. Thank God I have good insurance but in the end my medical out of pocket for all of this could cost me up to $4,500. Results came back 50% Suspicious for FN(Follicular Neoplasm) with positive HRAS c.18HRAS c.182A>G (Q61R) All I can say is that in reviewing my ultrasounds and the report from the interventional radiologist and the Affirma report, I have noticed that there are inconsistencies in even the reported measurements of the nodules and now that I have read further into studies done on people undergoing thyroid removal after getting "Suspicious"/40% of Cancer Affirma results, there are many more false positives than Afirma would have you understand. 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]). Long-Term Outcomes of Thyroid Nodule AFIRMA GEC Testing and Literature Review: An Institutional Experience. Glad to have found Inspire to learn more, and support others, and receive support. Any help really will be appreciated. Afirma Suspicious results - Thyroid cancer - Inspire Clipboard, Search History, and several other advanced features are temporarily unavailable. They were incredibly supportive and also concerned. He tried to console me but he was also upset. The .gov means its official. A woman on the excellent health site Medhelp told me she had a 3cm. Thyroid Nodules: https://www.thyroid.org/thyroid-nodules/. Hello, new here and confused, anxious and a bit worried. She also said that her surgeon also had 5 other patients that had the Afirma test done,and said their nodules were suspicious too and they all were found to benign after they were removed! https://www.inspire.com/groups/thyca-thyroid-cancer-survivors-association/discussion/need-advice-surgery-or-not-based-on-40-afirma-test/?page=2#replies. 4) How do I make sure I get the best care? Which if they used the YTD income they could clearly see that I qualified for a reduced billing. Anyone have AUS nodule with suspicious Afirma results end up cancerous? My question is then I guess, is it really that bad afterwards managing levels and the other side effects post TT? 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.". Please enable it to take advantage of the complete set of features! Conversely, when evaluating nodules with suspicious molecular testing, surgical rates were 88% and 89%, respectively, for GEC and GSC (P = 0.853) . Wong KS et al. In early September, at a well-woman visit, my primary care doctor found a lump in my neck and sent me for a sonogram that found three nodules -- one estimated at 3.5 cm, one at 1.5 cm and the third much smaller. My surgeon wants to operate right away stating that these kind of results have a 90% truancy for cancer to be present. These results show an improved accuracy for the GSC as compared with the GEC. 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. Suspicious for neoplasm - Veracyte genomic testing? - MedHelp Afirma testing is back "Risk of malignancy: Afirma GSC Suspicious ~50%" "Malignancy classifiers: Negative" "MTC and BRAF classifier results were negative and RET/PTC1 and RET/PTC3 were not detected. All my blood tests and tsh levels are in the normal range. The overall PPV of an Afirma GSC suspicious nodule was 47%, regardless of variant/fusion status. Without my permission my specimen was sent to Affirma and their results were Benign, so my radiologist amended her results to benign for all 4 nodules. Baca SC, Wong KS, Strickland KC, Heller HT, Kim MI, Barletta JA, Cibas ES, Krane JF, Marqusee E, Angell TE. 2021 May 13;12:649522. doi: 10.3389/fendo.2021.649522. Have lots of decisions to make and just trying to do some homework. If you have benign results they always wonder. I opted to have the TT and it turned out it was cancerous and had spread to a few lymph nodes, so then I had right and left central neck dissections as well. PDF AFIRMA REQ: Sample Patient Report In this study from Boston, 63 thyroid surgical specimens were reviewed from patients whose thyroid biopsy samples were read as indeterminate and in whom the GEC test was reported as suspicious. 2013 Dec;24(6):385-90. doi: 10.1111/cyt.12021. At this point, I was exasperated by all of the running around, but fine. 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. http://www.glandsurgery.org/article/view/1002/1193, http://biotechstrategyblog.com/2012/06/veracyte-, Papillary and follicular thyroid cancer (differentiated), Multiple endocrine neoplasia type 2 (MEN2), Mental challenges of living with thyroid cancer, ThyCa fundraising and thyroid cancer research grants. It took about 8 days to get back results. The Afirma Xpression Atlas for thyroid nodules and thyroid cancer I posted the below post on this forum on several different topics since 2013. Independent Comparison of the Afirma Genomic Sequencing - PubMed However, researchers found that when the Afirma GSC identified a thyroid nodule with a TSHR mutation as suspicious, the risk of malignancy was 15.3%, a level of risk for which most physicians. Epub 2020 Aug 6. Right now my neck lymph nodes look good. This approach is being marked by several laborartories and was reviewed in the December 2011 issue of Clinical Thyroidology. The aim of this study was to determine the clinical performance of the GSC as compared with the GEC at one academic medical center. https://www.inspire.com/groups/thyca-thyroid-cancer-survivors-association/discussion/genetic-test-two-different-results/reply/6888430/?msg_activity=reply_posted. SUMMARY OF THE STUDIES Thyroseq PMC Suspicious Nodule Surgery the Only Option? At the end of the day, it is what it is now that I SWALLOWED (no pun intended) the I-131 pill, hopefully it won't work against me. If benign = no surgery, IF suspicious or malignant = surgery. Unauthorized use of these marks is strictly prohibited. http://www.glandsurgery.org/article/view/1002/1193 Biotech Strategy Blog in this post by Pieter Droppert June 28,2012 Also mentions 48% of nodules falsely called "suspicious" for cancer and can cause many people to have unnecessary thyroid surgery when they don't have cancerous thyroid cells! I asked him if I could get another opinion on my FNA slides and he said yes and I asked him who he could recommend that is very good with thyroid pathology and FNA's and he recommended quite a few Dr.'s so I asked about any at The Mayo Clinic where he used to work and did that Afirma study from,and he recommended three Dr.'s there. Until now, Afirma has been available as two tests: Afirma GSC and Afirma Xpression Atlas (XA).

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