Interpace Biosciences, Inc. announced new clinical validation data for their thyroid cancer test platform which is comprised of a mutation panel (ThyGeNEXT®) and a microRNA (miRNA) risk classifier. The new data demonstrates that the addition of miRNA pairwise expression profiling (ThyraMIR®v2) provides clinically and statistically superior risk stratification of indeterminate thyroid nodules (ITN) beyond that of the algorithmic classification analysis provided by the original ThyraMIR® assay. ThyraMIRv2 was developed and validated in a fully blinded cohort (n=197) from a previous retrospective validation study.

The new data analysis revealed improvement in the number of true negative results and reduction of false positive results with a subsequent improvement in the specificity and PPV at positive threshold, while preserving a high sensitivity and NPV. The ROC AUC increased from 0.85 to 0.97 (p<0.001), and the diagnostic accuracy at the positive threshold increased significantly (p<0.05) from 83% (CI, 76-88) to 93% (CI, 89-96). ThyraMIRv2 optimized risk stratification of nodules with RAS-like (weak driver) mutations, minimally invasive follicular carcinomas, low-grade PTC, and Hürthle cell predominant nodules—providing significant improvement in test accuracy and the higher NPV and PPV of commercially available tests.