PDI, Inc. Subsidiary Interpace Diagnostics Announces New Data Supporting Use of ThyraMIR™ - First and Only MicroRNA Gene Expression Classifier - with ThyGenX™ Thyroid Oncogene Panel to Improve Identification of Both Benign and Malignant Thyroid Nodules

PARSIPPANY, N.J., March 9, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced today new data supporting the use of combination platform testing with ThyraMIR™, the first and only microRNA expression classifier, and ThyGenX™ Thyroid Oncogene Panel, a DNA and RNA mutational analysis, to improve thyroid cancer diagnosis. The study, presented at ENDO 2015: The 97^th Annual Meeting & Expo of the Endocrine Society held March 5-8, 2015 in San Diego, CA, showed that benign or malignant nodules can be identified with high sensitivity and specificity resulting in clinically actionable negative predictive value (NPV) at 94% and positive predictive value (PPV) at 74%. The effect of combining nucleic acid sequencing with a gene classifier significantly improved the tests' ability to correctly identify both benign and malignant nodules, potentially resulting in fewer unnecessary surgeries.

In this histologically blinded, multicenter, cross-sectional cohort study, data was summarized from 109 nodules with indeterminate cytology and surgical outcomes of primary benign or malignant thyroid lesions established by local pathology expertise from 12 representative endocrinology centers across the United States. Following fine needle aspiration, combined use of mutation testing and ThyraMIR had an overall sensitivity of 89% and specificity of 85%. Importantly, researchers noted the improvements relative to current molecular classification methods are applicable regardless of the local prevalence of thyroid cancer.

"These promising results support the addition of microRNA testing to oncogene mutational analysis. This combined gene expression and genotyping approach is designed to more accurately diagnose and characterize thyroid nodules," said Thomas J. Giordano, M.D., Ph.D., Department of Pathology, University of Michigan, and a study author. "This can help clinicians to make the most appropriate management recommendations for their patients and hopefully avoid unnecessary surgeries on benign nodules."

Approximately 525,000 thyroid nodule fine needle aspiration (FNA) procedures are performed each year in the United States. Prevalence of thyroid cancer in the clinical setting is often not known and varies between institutions. Indeterminate cytology diagnoses are common and represent approximately 15% to 30% of cases. National Comprehensive Cancer Network (NCCN) and American Thyroid Association (ATA) guidelines currently recommend consideration of molecular testing on these indeterminate cases to help inform treatment decisions and to help avoid unnecessary surgery on benign nodules, which may occur in 70% to 80% of the cases.

"We are excited about these compelling data and that the use of this first and only microRNA gene expression classifier, combined with our thyroid oncogene mutational panel, can potentially further advance the diagnosis and treatment of thyroid lesions beyond currently available tests," said Nancy Lurker, CEO of PDI, Inc.

While studies support the value of mutational analysis, evidence continues to accumulate clearly showing that detection of ever-increasing numbers of uncommon mutations does not by itself provide diagnostic clarity, but in fact contributes to diminishing specificity for cancer detection.

Added Sydney Finkelstein, M.D., Chief Scientific Officer of Interpace Diagnostics: "A combined approach, fundamental to our testing, offers the most effective means to guide individual patient management and optimize healthcare resources."

A link to the abstract can be found at: https://endo.confex.com/endo/2015endo/webprogram/Paper18782.html. 

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.

About ThyGenX™ and ThyraMIR™

Interpace Diagnostics' ThyGenX™ Thyroid Oncogene Panel molecular diagnostic test 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 a 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 both 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.

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 November 5, 2014. 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.

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SOURCE PDI, Inc.

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