December 17, 2015
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ThyraMIR, ThyGenX may be effective for thyroid nodule diagnosis

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Findings from two studies suggest that the combination of a microRNA classifier and mutation detection test may be effective for diagnosing thyroid nodules.

Gyanendra Kumar, PhD, and colleagues from Interpace Diagnostics in New Haven, Connecticut, presented data on their molecular diagnostic tests for cancer with specific and accurate detection of benign and malignant thyroid nodules using the ThyGenX, an oncogene panel, and ThyraMIR, a microRNA classifier.

In the first study, researchers evaluated total nucleic acids for more than 100 alterations in the ThyGenX test and for a 10-marker microRNA profiling panel ThyraMIR test, which was designed to distinguish between benign and malignant disease.

“The full potential of combined [microRNA] classifier and mutational analysis of thyroid nodules has not yet been fully characterized. ... We document complementary aspects of performing both assays on the same sample to better diagnose and predict the clinical behavior or cytologically indeterminate thyroid nodules,” the researchers wrote.

The combination of both tests revealed greater sensitivity and specificity compared with ThyGenX alone when evaluating surgical outcomes. Twenty-two percent of more than 1,000 fine-needle aspirates had reportable DNA mutations when using ThyGenX. ThyraMIR was effective for testing both mutation-negative and RAS-mutated nodules.

“While each approach, mutation detection and [microRNA] classifier, showed individual limitations, the combination effectively addressed shortcomings,” the researchers wrote.

In the second study, researchers evaluated total nucleic acids for corresponding cyto-centrifugation supernatant fluids containing cell-free nucleic acid using the ThyGenX and ThyraMIR tests.

Both tests were successfully carried out from formalin-fixed paraffin embedded tissue sections, monolayer cyto-slides and stained smear slides. Further, both tests successfully analyzed cell-free nucleic acids in cyto-centrifugation supernatant flued, discarded in cytology. The molecular testing also showed benefits over fresh, needle aspirates.

“Here we show that combination testing for mutational and microRNA classifier is feasible with the potential to improve diagnosis and prediction of thyroid neoplasia and allied lesions,” the researchers wrote.

Disclosure: Kumar reports no relevant financial disclosures.