The accurate diagnosis of thyroid nodules can be challenging, with 15-30% of Fine Needle Aspiration (FNA) samples classified as indeterminate.1 Patients with indeterminate nodules are often referred to surgery, though most of these nodules prove to be benign.2

With the advancement of molecular testing with RosettaGX Reveal, physicians are armed with more information than ever about whether surgery is necessary for their patients. This microRNA-based diagnostic assay evaluates cytologically indeterminate thyroid nodules and can help prevent over 75% of unnecessary surgeries for patients with initial indeterminate results.1

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The first thyroid test that works on stained FNA smears,
No Additional FNA Pass Required

99% NPV, 98% Sensitivity1 (for agreement set*)

Choice of Cytopathologist: Ability to use our experts or a Cytopathologist of your choosing

Slides are imaged and archived for future retrieval

Rapid turnaround time of 7 days

Recommended Use

For patients with indeterminate thyroid nodules, RosettaGX Reveal utilizes our proven microRNA platform to differentiate these nodules as benign, suspicious for malignancy, or as having high risk for medullary carcinoma (an aggressive form of thyroid cancer).

HOW IT WORKS

Evidence

The only commercially available molecular thyroid test that has been validated to use readily available FNA smears
Other thyroid diagnostic assays require an additional biopsy; RosettaGX Reveal can be performed using the existing smear from your patient’s initial biopsy.

High performance results
RosettaGX Reveal performance was determined in a multi-center, blinded validation study. 99% NPV and 98% sensitivity (n=150), Bethesda Class III, IV, V) was determined, with 3/3 Pathologists agreeing on diagnosis.1

94% success rate in obtaining results from single smear specimens. Additionally, Reveal can be performed on a variety of stain types.1,3

For full statistical analysis see reference: Bar D, Meiri E, et al., International Thyroid Congress, Orlando, October 18-23, 2015

View ACE 2016 Poster View ATA 2015 Poster

*Agreement set (n= 150) consists of those cases from the validation study where both outside Pathologists agreed with the original Pathologist’s post-surgical diagnosis (i.e., benign versus malignant). Entire validation set (n= 189) includes these 150 cases plus an additional 39 cases from the validation study where only one of the two outside Pathologists agreed with the original Pathologist’s post-surgical diagnosis.

 

References

  1. Bar D, Meiri E, et al. A First-of-its-Kind, microRNA-based Diagnostic Assay for Accurate Thyroid Nodule Classification. Poster presented at: 15th International Thyroid Congress (ITC) and 85th Annual Meeting of the American Thyroid Association (ATA); October 2015; Orlando, Florida.
  2. Alexander EK, Kennedy GC, Baloch ZW, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology. N Engl J Med. 2012;367(8):705-15.
  3. Benjamin H., Schnitzer-Perlman T., Shtabsky  A., VandenBussche C.J., Ali S.Z., Kolar Z., Pagni F., Group RG, Bar D., and Meiri E. Analytical Validity of a microRNA-based Assay for Diagnosing Indeterminate Thyroid FNA Smears from Routinely Prepared Cytological Slides. Cancer Cytopathology 2016 Oct;124(10):711-721.
  4. Lithwick-Yanai G., Dromi N., Meiri E., et al. Multicentre validation of microRNA-based assay for diagnosing indeterminate thyroid nodules utilizing fine needle aspirate smears. Journal of Clinical Pathology; Published online Oct 2016.