Interpace Diagnostics Group Inc, Parsippany, NJ, has received approval from the New York State Department of Health to launch ThyraMir diagnostic testing on formalin-fixed, paraffin-embedded (FFPE) tissue samples from thyroid nodules.
ThyraMir is now the only molecular test approved for use in the State of New York on indeterminate thyroid nodule samples presented via cytology slides, FFPE-fixed tissue specimens, or fine needle aspirates. In combination with previous New York state approval of the company’s next-generation thyroid product, ThyGeNext, physicians and patients now have increased access to Interpace’s thyroid product suite across a wide spectrum of specimen types, providing a single point of access for molecular testing.
The combination of ThyGeNext and ThyraMir represents the only test on the market that encompasses the rule-in properties of NGS analysis of the patient’s DNA and RNA, together with the rule-out capabilities of a micro-RNA classifier, to provide physicians with clinically actionable test results.
“We are pleased to have obtained approval from the State of New York, allowing us to utilize our thyroid tests across a full spectrum of specimen types,” says Jack Stover, president and CEO of Interpace Diagnostics. “With this increased convenience factor, we can now provide our thyroid molecular testing services to an even broader customer base.”
Approximately 20% of the 525,000 thyroid fine needle aspirations performed on an annual basis in the United States are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGeNext and ThyraMir.1
ThyGeNext and ThyraMir reflex testing yield high predictive value for determining the presence or absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decisionmaking when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGeNext utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer.
ThyraMir is the first microRNA gene-expression classifier. MicroRNAs are small, noncoding RNAs that bind to messenger RNA and regulate the expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMir measures the expression of 10 microRNAs.
Both ThyGeNext and ThyraMir tests are covered by Medicare and commercial insurers, with more than 280 million patients covered.
For further information, visit Interpace Diagnostics.
- Tang AL, Falciglia M, Yang H, Mark JR, Steward DL. Validation of American Thyroid Association ultrasound risk assessment of thyroid nodules selected for ultrasound fine-needle aspiration. Thyroid. 2017;27(8):1077–1082; doi: 10.1089/thy.2016.0555.