PDI, Inc., a leading healthcare commercialisation company, subsidiary of Interpace Diagnostics announced that both the ThyGenX Thyroid Oncogene Panel and ThyraMIR Thyroid miRNA Classifier, its molecular diagnostic tests for indeterminate thyroid nodules, are now covered by one of the largest independent Blue Cross Blue Shield plans that insures 3.3 million lives.
This medical policy update, covering both ThyGenX and ThyraMIR, represents the first large commercial plan to cover ThyraMIR, a novel microRNA gene expression classifier launched earlier this year. Furthermore, it follows the recent announcement of coverage by Aetna for ThyGenX, Interpace Diagnostics' genetic mutation panel used to improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis of thyroid cancer. The combination of all plans, including Medicare coverage of ThyGenX, represents a total of 80 million covered lives for Interpace Diagnostics' molecular thyroid diagnostic tests.
Coverage of PancraGen, Interpace Diagnostics' test for pancreatic cyst cancer risk stratification, was also recently extended to an additional 1.3 million lives by a contracted top national plan, bringing this plan's total covered lives for PancraGen to 10 million. Additionally, one of the country's largest Blue Cross Blue Shield plans renewed PancraGen contract coverage for their 5.9 million lives. These plans recognise the value in identifying patients at risk of progression to pancreatic cancer and those at a lower risk with a high degree of accuracy, by ensuring their members have access to this technology. The combination of all plans, including Medicare coverage of PancraGen, represents over 70 million covered lives for this molecular test.
"Coverage by these additional plans provides further validation of our tests' value to their members," said Nancy Lurker, chief executive officer of PDI, Inc.
She adds, "We continue to advance discussions with other plans to increase coverage for our tests, efforts which will both benefit patients and further accelerate the current growth taking place at Interpace Diagnostics, our molecular diagnostics business."
Approximately 15 per cent to 30 per cent of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis are indeterminate based on standard cytological evaluation and thus candidates for ThyGenX Thyroid Oncogene Panel. Guidelines from the National Comprehensive Cancer Network (NCCN) indicate that molecular diagnostic approaches may be useful in the evaluation of thyroid FNA samples that are indeterminate to assist in patient management, including identifying patients who are appropriate candidates for surgery and those for whom surveillance is the appropriate course of action.
ThyGenX is used to improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis of thyroid cancer. ThyGenX assists physicians in distinguishing between benign and malignant genotypes in indeterminate thyroid nodules by utilising 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 has now enhanced it by upgrading to an NGS platform, providing greater genomic insights and increased panel content.
ThyraMIR Thyroid miRNA Classifier is the first and only 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.
More than 120,000 pancreatic cysts are detected annually in the US. Most of them are identified incidentally by imaging studies targeted at identifying other conditions. Given the high mortality rate associated with pancreatic cancer, it is critical that these cysts are quickly identified as either having low or high potential for malignancy.
PancraGen has 90 per cent accuracy in stratifying patients for risk of pancreatic cancer with better accuracy than standard guideline-recommended tests alone. PancraGen provides information that enables physicians to make more informed management decisions for patients with pancreatic cysts, including whether surgery or surveillance is the most appropriate approach. Due to the limitations of standard first-line tests, up to 80 per cent of surgeries on pancreatic cyst patients are potentially unnecessary. Such overtreatment can cause lifelong consequences to patients, including diabetes. PancraGen utilises the PathFinderTG platform to assess multiple tumour suppressor and oncogene DNA abnormalities. The test then integrates this DNA analysis with clinical features of pancreatic cysts. All patients with pancreatic cysts, except those with clear cytological malignancy, are ideal candidates for testing with PancraGen.