Interpace Diagnostics Announces Additional Coverage in Top Managed Care Health Plans for Their Thyroid and Pancreas Molecular Diagnostic Tests

ThyGenX™ and ThyraMIR™ Gain Coverage with Large Regional Payer

PancraGen™ Contracted Coverage Extended Among National and Key Regional Payers

Aug 13, 2015, 16:27 ET from PDI, Inc.

PARSIPPANY, N.J., Aug. 13, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary Interpace Diagnostics announced today 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 recognize 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, CEO 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."

About Thyroid Nodules, ThyGenX and ThyraMIR
Approximately 15% to 30% 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 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 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.

About Pancreatic Cysts and PancraGen
More than 120,000 pancreatic cysts are detected annually in the U.S. 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% 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% of surgeries on pancreatic cyst patients are potentially unnecessary. Such overtreatment can cause lifelong consequences to patients, including diabetes.  PancraGen utilizes the PathFinderTG platform to assess multiple tumor 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.

About PDI, Inc.
PDI is a leading healthcare commercialization company providing go-to-market strategy and execution to established and emerging pharmaceutical, biotechnology, diagnostics and healthcare companies in the United States through its Commercial Services business, and developing and commercializing molecular diagnostic tests through its Interpace Diagnostics business. PDI's Commercial Services is focused on providing outsourced pharmaceutical, biotechnology, medical device and diagnostic sales teams to its corporate customers. PDI's Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. For more information about us, please visit www.pdi-inc.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. PDI has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.  These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond PDI's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause PDI's actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the market's acceptance of our molecular diagnostic tests; projections of future revenues, growth, gross profit and anticipated internal rate of return on investments; the loss, early termination or significant reduction of any of our existing service contracts; the failure to meet performance goals in PDI's incentive-based arrangements with customers; the inability to secure additional business; or our inability to develop more predictable, higher margin business through sales of our molecular diagnostic tests, in-licensing or other means. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in PDI's periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 5, 2015 and in PDI's Form 10-Q filed with the SEC on May 12, 2015. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, PDI undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

i Al-Haddad MA, Kowalski T, Siddiqui A, et al.; Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts.  DOI: http://dx.doi.org/10.1055/s-0034-1390742; Published online: 14.10.2014; Endoscopy 2015; 47: 136–142; © Georg Thieme Verlag KG;  Stuttgart · New York;  ISSN 0013-726X

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