Interpace Diagnostics Corp., a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management, has received approval from a major national managed care organization to cover ThyraMIR, the first micro RNA classifier made available for improving the diagnosis of indeterminate thyroid nodules.
This approval brings the total number of covered lives in the United States for ThyraMIR to more than 130 million. Coverage by this national plan was previously approved for ThyGenX, the Company's Next Gen oncogene panel used to assist physicians in distinguishing between benign and malignant thyroid nodules. The combination testing of ThyGenX/ ThyraMIR addresses an important unmet clinical need for more actionable information in evaluating the risk of cancer.
"This decision by a major national plan to cover ThyraMIR provides further evidence and validation of the utility of this test," commented Jack Stover, Interpace's Interim CEO. "It is important to note that ThyraMIR is a reflex assay that must be used in conjunction with ThyGenX and now having both tests covered by this national plan is an important milestone. This approval, when combined with our recent announcement of Medicare coverage, is a strong indication of the growing acceptance and support of our Thyroid product offerings," concluded Stover.
ThyGenX is used to improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis of thyroid cancer. Accordingly, ThyGenX assists physicians in distinguishing between benign and malignant genotypes in indeterminate thyroid nodules by utilizing 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 malignancies. The ThyGenX panel design is based on the miRInform® test, whose high predictive value has been validated in a recent prospective clinical study involving over 600 patients. Interpace Diagnostics acquired the miRInform test from Asuragen in 2014, and the test has subsequently been upgraded to an NGS platform, providing greater genomic insights and increased panel content.
ThyraMIR miRNA Classifier is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs and, when used in combination with ThyGenX, yields high negative predictive value and high positive predictive value. This results in improved molecular classification of both benign and malignant thyroid nodules independent of thyroid cancer prevalence in the clinical setting.
PancraGEN is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cyst diagnosis and pancreatic cancer risk assessment. PancraGEN is 90% accurate, according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.