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Sensitivity and Specificity of the NETest: A Validation Study.
Taymeyah Al-Toubah1, Mauro Cives2, Tiffany Valone1
1Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center, Tampa, Florida, USA.
Neuroendocrinology
|July 3, 2020
Summary
The novel NETest blood assay shows high sensitivity for detecting neuroendocrine tumors (NETs). Specificity is excellent in healthy individuals but lower in patients with other gastrointestinal cancers.
Area of Science:
- Oncology
- Molecular Diagnostics
- Biomarkers
Background:
- Traditional secretory tumor markers for neuroendocrine tumors (NETs) lack clinical utility due to poor sensitivity and specificity.
- A novel blood multigene RNA transcript assay, the NETest, demonstrates high sensitivity and specificity.
Purpose of the Study:
- Validate the sensitivity of the NETest in metastatic well-differentiated NETs.
- Evaluate the NETest specificity in metastatic non-NET gastrointestinal (GI) malignancies and healthy individuals.
Main Methods:
- Study included 49 patients with metastatic NETs, 21 with other metastatic GI cancers, and 26 healthy individuals.
- Samples were analyzed via a blinded central laboratory using the NETest.
- An initial normal range of 0-13% was used, later updated to 0-20%.
Main Results:
- NETest sensitivity was 98% in metastatic NETs.
- Overall specificity was 66% with the 0-13% normal range.
- With the 0-20% range, specificity was 100% in healthy individuals but 67% in patients with other GI cancers.
Conclusions:
- The NETest exhibits exceptional sensitivity (>95%) for metastatic, well-differentiated NETs.
- Specificity is high in healthy individuals with a 0-20% normal range.
- Specificity is limited in patients with other GI malignancies.
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