AFIRMA GENOMIC SEQUENCING CLASSIFIER

Description of Event or Problem

HELLO, I REALIZED THAT I DID NOT INCLUDE MY CONTACT INFORMATION IN MY PREVIOUS REPORT. THIS IS THE SAME REPORT AS THE PREVIOUS ONE, BUT WITH MY EMAIL ADDRESS INCLUDED. I AM WRITING, AS A PATIENT, TO RAISE YOUR ATTENTION AND TO REPORT THE INAPPROPRIATE USE AND MISLEADING RESULTS OF AFIRMA GENOMIC SEQUENCING CLASSIFIER TEST ((B)(6), CA) FOR THE DIAGNOSIS OF THYROID CANCER. IN (B)(6) 2023, I WAS DIAGNOSED WITH A THYROID NODULE WITH THE SIZE OF 2.2 CM. THE 1ST ENT (EAR, NOSE AND THROAT) DOCTOR STRONGLY SUGGESTED PROMPT SURGICAL REMOVAL OF THE THYROID, BASED ON THE "~50% MALIGNANCY" DIAGNOSIS BY THE AFIRMA TEST. SINCE I HAD BEEN STRONGLY AGAINST SURGERY UNLESS IT IS TRULY NECESSARY, I.E., THYROID CANCER, I THEN SOUGHT SECOND OPINION. HOWEVER, THE 2ND ENT DOCTOR ALSO FIRMLY SUGGESTED PROMPT SURGICAL REMOVAL OF THE THYROID, POINTING OUT THE "~50% MALIGNANCY" DIAGNOSIS WITH THE AFIRMA TEST, AND SCHEDULED A SURGERY. AS A RESULT, I HAD A SURGICAL REMOVAL OF MY RIGHT THYROID ON (B)(6) 2024. THE BIOPSY RESULTS FROM THE SURGICALLY REMOVED SAMPLE TURNED OUT TO BE BENIGN. ALTHOUGH RELIEVED OF NON-CANCER, THE FACT THAT I LOST A THYROID PERMANENTLY IS DEVASTATING. CLEARLY, THIS IS A SURGERY THAT IS NOT NECESSARY. AFTER THE SURGERY, I WAS TOLD THAT I MAY NEED THYROID SUPPLEMENT FOR THE REST OF MY LIFE. MOREOVER, I LIVE DAILY WITH A VARIETY OF SEVERE SYMPTOMS TILL TODAY, WHICH THE NURSE SAID "NORMAL" POST-SURGERY ¿ LACK OF ENERGY/STRENGTH, DIZZINESS, DIARRHEA FROM TIME TO TIME, AND EASY TO FEEL UPSET OR EVEN DEPRESSION. THE PAST TWO MONTHS AFTER THE SURGERY HAS BEEN AN ORDEAL FOR ME AND MY FAMILY. IN THE AFIRMA TEST REPORT I RECEIVED, IT ONLY LISTS THE TEST WITH "SENSITIVITY 91%, SPECIFICITY 68%", WITHOUT ANY INFORMATION ON THE "ACCURACY" OF THE TEST. IT APPEARS THAT BOTH ENT DOCTORS I VISITED DID NOT KNOW THE LIMITATIONS OF THE AFIRMA TEST: (1) THE TEST DID NOT PROVIDE ANY ACCURACY DATA; (2) THE TEST HAS LOW SPECIFICITY OF 68%; (3) THE REPORTED DIAGNOSIS OF MY THYROID MALIGNANCY IS ~50%. IT WOULD BE FAIR TO SAY THAT THIS TEST IS NO BETTER THAN FLIPPING A COIN. HOWEVER, BOTH ENT DOCTORS USED THE TEST RESULTS AS KEY INFORMATION TO SUPPORT THE NECESSITY OF PROMPT SURGICAL REMOVAL OF MY THYROID, EVEN AFTER I RAISED MY CONCERNS ABOUT THE TEST. BASED ON MY DEVASTATING EXPERIENCE, I STRONGLY URGE FDA TO INVESTIGATE THE VALIDITY OF THE AFIRMA TEST FOR THE DIAGNOSIS OF THYROID CANCER AND/OR OTHER CANCERS. ALSO, I STRONGLY SUGGEST THAT THIS TEST NOT BE USED, OR AT THE VERY LEAST, MEDICAL PROFESSIONALS BE WARNED TO USE THE TEST WITH EXTREME CAUTION AS GUIDANCE FOR THYROID MALIGNANCY. I REALLY HOPE THAT MY EXPERIENCE COULD HELP OTHER PATIENTS. I BELIEVE THAT NO PATIENTS SHOULD BE PUT INTO SIMILAR SITUATIONS AT ANY TIME. THANK YOU VERY MUCH FOR YOUR ATTENTION.