Interpace Diagnostics, a US-based company, has obtained the approval from New York State Department of Health for ThyraMir miRNA Test for indeterminate thyroid nodules.
ThyraMir is the company’s micro RNA gene-expression based test to classify indeterminate thyroid nodule results from fine needle aspirates and biopsy specimens.
MicroRNAs are small, non-coding RNAs that fuse with the messenger RNA and take control over the expression of genes involved in human cancers, including every subtype of thyroid cancer.
It can measure the expression of up to 10 microRNAs.
ThyraMir was initially launched last year by the company and was made available to endocrinologists and pathologists.
Interpace Dignostics president and CEO Jack Stover said: "We are pleased with the New York State acceptance of our data submission for ThyraMir.
"This is a significant milestone and further confirms the overall robust performance of our test."
The ThyraMIR testing complements the company’s oncogene (mutational) panel, ThyGenX, which is used to detect thyroid cancer from thyroid nodules leveraging on the next generation sequencing assay.
Both ThyraMIR and ThyGenX can be used in conjunction, where the former can detect malignancy in nodules that was proved negative through ThyGenX, thereby offering sensitivity and ability in its mechanism of detection of malignancy.
The company has also filed to obtain the New York State approval for ThyGenX which is intended to be used to identify specific biomarkers warranting the reflex to ThyraMir testing.