Massoll, Nicole1, 2; Benjamin, Hila1; Schnitzer-Perlman, Temima3; Mitchell, Heather1; Noller, Melissa1; Evoy-Goodman, Lisa1; Kushnir, Michal3; Lithwick Yanai, Gila3 and Meiri, Eti3
1 Rosetta Genomics Inc., Philadelphia, PA, USA
2 University of Arkansas for Medical Sciences, Little Rock, AR, USA
3 Rosetta Genomics Ltd., Rehovot, Israel
Background: Assessing the risk of malignancy in indeterminate thyroid lesions, which comprise ~10-30% of Fine Needle Aspirate (FNA) cytology diagnoses1,2, is a challenging task. Without the use of molecular tests, the rate of surgery in indeterminate lesions is 74% and in most cases, the surgical diagnosis is benign3,4. RosettaGX Reveal™ is a microRNA-based test that effectively classifies ITNs into benign, suspicious for malignancy or positive for medullary carcinoma, utilizing stained FNA smears5. In the current study, we aim to characterize Reveal’s performance in the clinical setting and to examine its contribution to personalized case management.
Methods: Over 1300 cases were tested using Reveal in the RosettaGX Laboratory in Philadelphia. To gain insight into the test’s impact on patient management an online survey was distributed to physicians who utilize Reveal.
Results: Successful processing was achieved in 94% of clinical samples, over 70% of which were Bethesda III. Benign call rate was 66%, 33% were suspicious for malignancy and 1% were positive for medullary marker.
Survey respondents remarked on the ease of use of Reveal and the impact the test had on their treatment decisions. According to the survey, Reveal’s main strength is in identifying indeterminate cases that should avoid repeated FNA or surgical intervention.
Discussion & Conclusion: RosettaGx Reveal proves to be a useful tool for clinical diagnosis of ITNs. According to our survey, using Reveal dramatically reduced the surgery rate, thus significantly decreasing the number of unnecessary surgeries and the costs associated with these surgeries.
- Bongiovanni M, Spitale A, Faquin WC, et al. The Bethesda system for reporting thyroid cytopathology: a meta-analysis. Acta Cytol 2012;56:333–9.
- Cibas ES, Ali SZ. The Bethesda system for reporting thyroid cytopathology. Am J Clin Pathol 2009;132:658–65.
- Duick DS, Klopper JP, Diggans JC, et al. The Impact of Benign Gene Expression Classifier Test Results on the Endocrinologist–Patient Decision to Operate on Patients with Thyroid Nodules with Indeterminate Fine-Needle Aspiration Cytopathology. Thyroid 2012; 22(10): 996-1001.
- Wang CC, Friedman L, Kennedy GC, et al. A large multicenter correlation study of thyroid nodule cytopathology and histopathology. Thyroid 2011; 21(3):243-51.
- Lithwick-Yanai G, Dromi N, Shtabsky A, et al. Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilizing fine needle aspirate smears. J Clin Pathol. 2016 Oct 26. doi: 10.1136/jclinpath-2016-204089. [Epub ahead of print]