Until now, Afirma has been available as two tests: Afirma GSC and Afirma Xpression Atlas (XA). Have lots of decisions to make and just trying to do some homework. Genes: a molecular unit of heredity of a living organism. I didn't take the nodule too seriously, but did see a specialist and also got the FNA. 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! The doctor is an Endocrine Surgeon that specializes in Thyroid/Parathyroid and Adrenal surgeries. Of the 164 nodules included in the study with the GSC test, suspicious nodules were found in 39 of the 164 nodules (23.7%). 1. The Afirma Genomic Sequencing Classifier (GSC) classifies cytologically indeterminate thyroid nodules as molecularly benign or suspicious. eCollection 2021. A group of expert pathologists have recently identified a subgroup of papillary thyroid cancer called noninvasive follicular variant papillary thyroid cancer that has a very low risk of relapsing after surgical removal. 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. Epub 2018 Apr 10. It is unclear whether mutations in these genes cause the cancer or are just associated with the cancer cells. I welcome your thoughts on my case. Largest is 2.3(previously 1.8cm in 2014) different test center though. 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? Neither will talk to the other. This study suggests that more research is needed to determine if the noninvasive follicular variant thyroid cancer can be diagnosed by molecular markers without proceeding to surgery. 8600 Rockville Pike microRNA: a short RNA molecule that has specific actions within a cell to affect the expression of certain genes. 1). Epub 2020 May 21. This study investigated the outcome of the thyroid nodules deemed to be "suspicious" by the Afirma GEC in a high risk population. 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. This site needs JavaScript to work properly. So when I say the doctor's says suspicious for cancer with a 75% possibility, I'm not sure how she gets 'unlikely' from that. She didn't seem overly concerned based on all my previous records. Method: o The Afirma MTC testing must be billed as part of the Afirma GSC. https://www.inspire.com/groups/thyca-thyroid-cancer-survivors-association/discussion/afirma-thyroid-analysis/. Accessibility I'm looking for any and all help and/information you can share with me. False positive rate of Afirma was 56% (32/57). I'm so happy because I just thought I would be struggling a lot more. 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 hesitant to go to surgery with the 30% cancer chance without more information. Afirma said NEGATIVE for BRAF and Meduliary but still assigned a classification of "Suspicious" with 40% chance of cancer. It's really upsetting to suddenly be thrust into this with no symptoms, etc. Would you like email updates of new search results? The Afirma GSC is designed to help clinicians manage these patients. Recently I change insurance and in doing so, my new doctor ordered a ultrasound which showed the nodule and he felt it was nothing to worry about. I'm not against surgery if needed, but wondering shouldn't it be followed for a bit before such a drastic measure is taken. I was doing some research and came across the Afirma Thyroid Analysis by Veracyte and was wondering if anyone in a similar situation had tried this and what there results were. Just underwent Afirma and Asurgen testing on the suspicious one. 2020 May;162(5):634-640. doi: 10.1177/0194599820911718. Lastly I do 25mcg of levothyroxine once a day for Hypothyroidism, it was prescribed based on lab results, not on how I was feeling. The positive predictive value of the GSC is 47.1%.1 Results Afirma GSC results may help guide surgical decision making in patients with thyroid nodules. They call follicular neoplasms with hurthle cells FNOF. Treatment like a cytologically benign nodule may be appropriate, including clinical correlation. Afirma GSC is a pre-operative genomic test for thyroid tumor biopsies that have . Third, I have no history of thyroid cancer (or any cancer) in my family. Some people say I should have had my thyroid out years ago. Clinician should therefore exercise caution in using this result for treatment decisions. It is such a major decision that the more info you have in making the decision the better. I had numerous FNA biospy's last result "suspicious for follicular neoplasm " , the last ultrasound showed several microcalcifications on left and scattered microcalcification on the right. Awaiting pathology. The results were suspicious of papillary cancer, but not conclusive. result (eg, benign or suspicious) Public Comment. I'm curious, if you had similar biopsy results and had surgery, was your final path malignant or not? 2020 Sep;8(9):e1288. She then tells me that at a recent conference, there was a lot of discussion of Afirma, and the general consensus seemed to be that it was good at detecting papillary cancer, but not necessarily follicular. I wish you luck in whatever you decide. Indeterminate thyroid nodules in the era of molecular genomics. Each wait has been tough, but the wait after the biopsy was excruciating. and transmitted securely. I know how frustrating, scary and expensive this whole process is.I am sorry that you are going through it!! My Afirma results also came back as "suspicious." However, I was not informed of this. After some research of my own, I decided to leave it. Thanks so much! http://www.glandsurgery.org/article/view/1002/1193. She also said that her endo said that all of his colleagues stopped using this test and that in their experience the number of suspicious that came back cancerous is the same as what you find in the general population. 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 was told that my thyroid needs to be removed (at least half, possibly all). Results: Thirty-eight TP53 variants were present among >13,000 Bethesda III/IV Afirma GSC Suspicious samples. 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. WHAT ARE THE IMPLICATIONS OF THIS STUDY? In such cases, testing of molecular markers related to thyroid cancer may help determine the risk of cancer. 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. The main goal was to help decide if my "suspicious for neoplasm" nodule was benign or not. 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% Qualifiers of atypia in the cytologic diagnosis of thyroid nodules are associated with different Afirma gene expression classifier results and clinical outcomes. 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). Wong KS et al. It was found incidentally in an MRI I had for cervical spine pain. The .gov means its official. Thyroid 29:11151124. I had three biopsies on a completely solid 2.0cm nodule, all which came back indeterminate/AUS. 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. Are you sure you want to block this member? Incidental papillary thyroid carcinoma, .2 cm on Left lobe and Thyroid right lobe: 1.2 cm nodule-Papillary thyroid carcinoma, conventional and follicular variant, histologically infiltrating into adherent skeletal muscle: .2 cm and the right lobe: 1.4 cm, both 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. 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. What should I know? If benign = no surgery, IF suspicious or malignant = surgery. However, its relatively low positive predictive value (PPV) limited its use as a classifier for patients with suspicious results. I didn't want to live with the risk, especially already being hypo and having nodules on the other side slowly growing. Don't want to gain weight or feel less optimal then I am now. The doc mentioned the thyroid and upon a physical exam felt the nodule, leading to the rest of the testing. This was done in hopes of maintaining my own thryoid function which the doctors and I felt better than taking thyroid medicine daily for the rest of my life. 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. This process has helped me to realize that there is a lot that physicians do not understand--much more than I knew. Gorshtein A, Slutzky-Shraga I, Robenshtok E, Benbassat C, Hirsch D. Eur Thyroid J. Variant: Afirma XA: Informs selection of surgical and therapeutic decisions for Afirma GSC Suspicious, Bethesda V, and Bethesda VI nodules 1 Is clinically validated 1 and informed by The Cancer Genome Atlas (TCGA), 2 extensive published literature, and Veracyte R&D discovery using nearly 40,000 samples 3 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. So the jump from that mentality to that of, "oh, I can get cancer, too" has big a huge one for me. My blood tests came back totally normal and I am totally asymptomatic. doi: 10.1002/mgg3.1288. Two have been tested by FNA multiple times over 5 years I had that one sent to Afirma, and it came back indeterminate on cytopathology again, benign on GEC. I could feel food getting lodged in my throat, and felt a pinch like a nerve at times, too. I have multiple nodules. The doctor uses a very thin needle to withdraw cells from the thyroid nodule. 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) . 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. Dr.Jerome Hershman. Among the 25 papers that approached Afirma GEC, four studies enrolled an additional number of 635 TNs from 596 patients to evaluate the Afirma GSC (16, 17, 57, 70). The authors concluded that a GEC suspicious test result may include noninvasive follicular variant papillary thyroid cancer as well as classical papillary thyroid cancer. Later that week I received a call telling me it was suspicious and was referred to an ENT which I saw yesterday. Home Patients Portal Clinical Thyroidology for the Public October 2016 Vol 9 Issue 10 p.11-12, CLINICAL THYROIDOLOGY FOR THE PUBLIC Unauthorized use of these marks is strictly prohibited. My question is then I guess, is it really that bad afterwards managing levels and the other side effects post TT? I have made an appointment with another endocrinologist, but just to talk to him. 2021 Apr;10(2):168-173. doi: 10.1159/000509037. Maternal side history of goiter in females, no known thyroid cancer, but late breast cancer and colon cancer One of the hardest things about all of this is the adjustment. A test with a better NPV (negative predictive value), would be more usefu than ever in that situation. I had a lobectomy sep. 30th. The two types that are set to be reclassified are the non invasive encapsulated type and the non invasive unencapsulated type. Many endocrinologists have written articles in The American Thyroid Association's journal criticizing the inaccuracies and unrelabilities of this recent Afirma test, the strongest criticism and concern is by endocrinologist of (*50* years!) 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. The pathology report on the removed nodule said: The mindset of most surgeons is to cut it out - ignoring the risks of that approach. I have found this community very informative, thank you. Suspicious Nodule Surgery the Only Option? They incidentally found a nodule on my right thyroid tru CTSCAN in Dec.2014. Thanks. Methods: I do not have calcifications but all 4 nodules are solid, hypoechoic and vascular. Several thyroid nodules. A publication of the American Thyroid Association, Suspicious readings of the Afirma gene-expression classifier include some noninvasive encapsulated follicular variant of papillary thyroid carcinomas. A month ago I had the Afirma test and it came back positive - suspicious for cancer which increased my chance from 5% to 50%. 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. Adherence to Active Surveillance and Clinical Outcomes in Patients with Indeterminate Thyroid Nodules Not Referred for Thyroidectomy. The Afirma MTC may not be billed separately using an additional unit or procedure code. I heard about the Afirma analysis , spent $5000 on the test and the results are even more confusing !! My Afirma results came back suspicious. Am I being reasonable? 1) Cytologist did not classify this as a Hurthle Cell Lesion Is it a Hurthle Cell Lesion due to predominance of Hurthle Cells? Paratracheal nodule (inclduing B1FS): Thyroid Parenchyma, negative for tumor. The rest were called benign by the GEC. However, FVPTC is currently classified as a type of "papillary" carcinoma, so the rate of diagnosis is also going to fall pretty substantially. 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! Hopefully soon afterward, I'll learn about whether or not the cells are cancerous and can begin to plan my next steps toward recovery. So I gather if I am reading what you reported correctly, your case is another false NEGATIVE for the Afirma test? I'm now 3 days post op and other than some difficulty swallowing and talking loud, I'm feeling great. I am very resistant to the thought of having a gland removed that is functioning perfectly fine, if it isn't cancer. Genes: a molecular unit of heredity of a living organism. THE FULL ARTICLE TITLE: FOIA Bethesda, MD 20894, Web Policies Thyroid nodule: an abnormal growth of thyroid cells that forms a lump within the thyroid. Epub 2020 Mar 17. -FNAB Result: Predominantly Hurthle Cells, Abundant Macrophages, Colloid and Bloody Background: Bethesda 3 (FLUS/AUS) Patients usually return home or to work after the biopsy without any ill effects. As I have learned on this board, just 'taking a pill' for the rest of your life isn't as easy as it sounds. The surgeon was great. Please click on this link below about the woman 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! I called my husband before I even received the callback, and couldn't stop crying. 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. o The Afirma MTC testing must be billed as part of the Afirma GSC. One such molecular marker test is the Afirma gene expression classifier (GEC) test. I feel good for 55 and slid through menopause easily. I've swallowed the I-131 pill, what are negative effects in the long run? Baca SC, Wong KS, Strickland KC, Heller HT, Kim MI, Barletta JA, Cibas ES, Krane JF, Marqusee E, Angell TE. Results: Please Help! http://onlinelibrary.wiley.com/doi/10.1002/cncy.21455/full. They did not address that issue in their letter, just my income. 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 . Hello, What was your experience? The cancer-associated genes important in thyroid cancer are BRAF, RET/PTC and RAS. However, the results are not conclusive. The panel includes genes that have been identified 6. 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. (Afirma GSC suspicious, suspicious for malignancy, or malignant cytopathology) ,2,4,8 I've enjoyed good health for my whole life. 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. Thyroid bloodwork normal. Recommended surgery for suspicious cancer cells. On the day before Thanksgiving, I returned home from work to discover a recorded phone message from the endocrinologist's office. Which means I would still be paying this amount to the hospital if I didn't pay it to Affirma. No lymphovascular invasion is identified. They were incredibly supportive and also concerned. The rate of malignancy in nodules suspicious for neoplasm (SN) on cytology interpretation was 31.2% (5/16). 3. So now I feel I have no choice to take it out (the nodule also grew .5 cm since the Aug test). It took about 8 days to get back results. Advice needed please. The Annual International Thyroid Cancer Survivors' Conference and Regional Workshops, Download our free Low-Iodine Cookbook (PDF), Rally for Research and Thyroid Cancer Research Grants. WHAT ARE THE IMPLICATIONS OF THIS STUDY? Because of this rather benign course, some pathologists have even questioned whether this subgroup is a cancer after all. I have slightly high blood pressure and slightly high cholesterol that are well controlled with meds. I was told my path report from the local hosp was inconclusive so it had to be sent to Mayo Clinic and after almost three weeks after my surgery, I got the word that it was cancerous. Afirma said NEGATIVE for BRAF and Meduliary but still assigned a classification of "Suspicious" with 40% chance of cancer. 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. 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. 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. Disclaimer. My surgeon wants to operate right away stating that these kind of results have a 90% truancy for cancer to be present. Is one easier to recover from ? My Enfo bumped up my Synthroid right away to adjust for the surgery. Upenn top thyroid pathologists including Dr.Virginia Lavosi report that follicular neoplasms with oncocytic (hurthle cells)often are misclassified as suspicious by the Afirma test! This occurs in 1520% of biopsies and often results in the need for surgery to remove the nodule. But still my labs are all within normal range. I'm curious, if you had similar biopsy results and had surgery, was your final path malignant or not? Of the 16 cases of follicular variant papillary thyroid cancer, 14 of them were noninvasive follicular variant of papillary thyroid cancer (88%). Mine did, and that can also be a sign of cancer. Everyone's story and experience seemed to be totally different. At this point, I was exasperated by all of the running around, but fine. Current analysis of thyroid biopsy results cannot differentiate between follicular or hurthle cell cancer from noncancerous adenomas. Just had TT yesterday. A woman on the excellent health site Medhelp told me she had a 3cm. 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.". He said this Afirma test is wrong half the time misclassifying benign nodules as suspicious,(I'm sure it's even more than half!) He tried to console me but he was also upset. I have also read a recent 2015 report that posits that there are built-in subjectivities to begin with at the Ultrasound/Pathology level yielding "Indeterminate" or "Atypical Cells" to begin with that then sets up a natural path to getting a "Suspicious" result from Afirma. They billed my insurance $6684 - my ins negotiatied $3370.40 they have billed me for 883.71, I applied for a reduction but they say I make too much income so I am not eligible for one. The biopsy (Afirma) was indeterminate with GSC suspicious with a 50% ROM. First off, I understand about 25% of suspicious actually turn out to be cancer (not that I should just "roll the dice") I wasn't one to resist. I think my biggest problem is what I read on the internet as far as all the problems afterwards. 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.". MeSH My radiologist determined that the smallest one had follicular cancer cells in her description but called it indetermined. See Somatic Mutation Testing - Solid Tumors guideline for criteria. He said there was no lymph node involvement but there's no way to tell until final path. How could it be Benign on one side and Suspicious on the other ? Thyroid. We conclude that cytology interpretation has a higher rate of predicting malignancy, in nodules interpreted as SN, when compared with the Afirma test, by almost twofold Diagn. Conclusion: All my blood tests and tsh levels are in the normal range. detect variants in greater than 50 genes. For those of you that had a thyroidectomy, how long did it take for you to realize that the medicine was or was not enough for you? Of the 343 nodules that underwent the GEC test, 178 cases (51.9%) were considered suspicious for cancer. 5) What are your thoughts on these results? Papillary Thyroid Cancer: the most common type of thyroid cancer. So I thought I was in the clear, and decided to just monitor this nodule for growth, and revisit the surgery idea only if size became an issue. Neither will talk to the other. I don't know if I'm speaking too soon, but the pain isn't as bad as I thought it would be. Also is anybody here familiar with "Afirma Thyroid Analysis" Our new findings show that the real-world experience supports this data, further demonstrating that the likelihood of malignancy in Afirma GSC-suspicious nodules is even greater than what was . And the 3rd test was Afirma which came back "suspicious". 2021 Oct 7;5(11):bvab148. Like she was just trying to tie up loose ends, and I happened to be one of those loose ends. Thyroid cancer is found in ~5% of thyroid nodules, so the vast majority are benign (noncancerous). The Xpression Atlas reports 905 genomic variants and 235 fusion pairs on GSC Suspicious, Suspicious for Malignancy (SFM), and Malignant FNA samples at the time of diagnosis. 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:( Used for FNA suspicious nodules (bethesda V-VI) or nodules deemed suspicious by the GSC classifier. The moment that I've been so nervous about finally came yesterday. More than one doctor has told me I should just have surgery, at least half the thyroid, maybe the whole thing. 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. It's pretty difficult being the patient trying to sort this all out.
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