Interpace Diagnostics Group announced it has extended its agreement with LabCorp for two additional years until January 2019 for the use of its ThyGenX and ThyraMIR molecular diagnostics, which provide enhanced options for the diagnosis of thyroid cancer in patients with indeterminate thyroid nodules. The two companies initially entered into an agreement in January 2016 for LabCorp to exclusively offer Interpace’s molecular tests.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX uses 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 measures the expression of 10 microRNAs— small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer.
“We are pleased to renew and extend our agreement with LabCorp, a world leader in healthcare diagnostics, said Jack E. Stover, president and CEO of Interpace Diagnostics. ” Execution of the initial phase of our arrangement has proven successful and we are encouraged by recent developments that clearly facilitate the opportunities to work even more closely together in the future.”
Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers. Two recent coverage decisions include CIGNA announcing in July it would cover the ThyGenX test for patients with indeterminate thyroid nodules, and in June Aetna announced positive coverage desicions for both ThyGenX and ThyraMIR.
According to the American Thyroid Association (ATA), approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR. Further, the ATA’s published guidelines support the use of molecular testing in those circumstances where traditional cytopathology is indeterminate and unable to differentiate between malignant and benign thyroid nodules.