PDI, Inc. Subsidiary Interpace Diagnostics Sets New Precedent with Launch of ThyraMIR™, First and Only MicroRNA Gene Expression Classifier for Thyroid Nodule Identification

Unsurpassed Performance in Identifying Benign and Malignant Thyroid Nodules, with Negative Predictive Value of 94% and Positive Predictive Value of 74% in Combination with ThyGenX™(1)

Apr 15, 2015, 08:00 ET from PDI, Inc.

PARSIPPANY, N.J., April 15, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced today the launch of ThyraMIR™, the first and only microRNA (miRNA) gene expression classifier for identification of indeterminate benign and malignant thyroid nodules. 

ThyraMIR, used in combination with ThyGenX™, Interpace Diagnostics' genetic mutation panel adapted and rebranded from Asuragen's miRInform® assay1, results in a Negative Predictive Value (NPV) of 94% and Positive Predictive Value (PPV) of 74%, at a cancer prevalence of 32%. ThyraMIR and ThyGenX achieve both high specificity of 85% and high sensitivity of 89%, allowing physicians the ability to more accurately identify and rule out thyroid cancer with a single testing regimen and within the histologically blinded, multicenter, cross-sectional cohort clinical validation study for ThyraMIR, which was recently presented at ENDO 2015: The 97th Annual Meeting & Expo of the Endocrine Society.  

ThyraMIR uses the expression levels of 10 miRNAs, small, non-coding RNAs deregulated in all human cancers, including thyroid cancer. ThyGenX identifies mutations and genetic alterations associated with differentiated thyroid cancers. The combination of ThyraMIR and ThyGenX produces a positive or negative cancer test result from thyroid nodule fine needle aspiration (FNA) procedures. Additionally, this combination provides a superior true benign call rate.

"A testing regimen that provides both high NPV and PPV would be highly predictive and significantly improve the physician's ability to correctly identify indeterminate thyroid nodules as being either benign or malignant," said Alexander Shifrin, M.D., endocrine surgeon, Jersey Shore University Medical Center. "This can potentially result in fewer unnecessary surgeries and improve patient management."

In the diagnosis of thyroid cancer, an FNA biopsy can present a clinical challenge. When physicians are leaning against surgery based on all clinical factors, typically a highly sensitive test is used to help confirm whether a thyroid nodule is benign. Conversely, when leaning toward surgery, a highly specific test is chosen to help confirm malignancy. When ThyraMIR and ThyGenX are used together, the result is greatly improved patient risk stratification - due to the very high likelihood that a negative result is truly benign and that a positive result is actually malignant.

Approximately 525,000 thyroid nodule 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 the launch of ThyraMIR and its combined use with our thyroid oncogene mutational panel, ThyGenX, as they further advance physicians' ability to correctly diagnosis thyroid nodules," said Nancy Lurker, CEO of PDI, Inc.

  1. A bridging study between the miRInform® and ThyGenXTM technology platforms demonstrated a concordance of 99.9% for the detection of the 17 gene alterations represented in the miRInform® panel. Interpace Diagnostics acquired the miRInform® test from Asuragen last year, and has now enhanced it by upgrading it to a Next Generation Sequencing Platform which offers greater genomic insights and added another molecular marker that has a strong correlation to malignant thyroid nodules, PIK3CA. 

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 ThyGenXand 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.

Corporate Media: Corinne de Palma CD Public Relations (212) 399-0887 Corinne@CDPublicrelations.net

Interpace Diagnostics Media: Caren Begun Green Room Communications (856) 424-2023 caren@greenroompr.com

Investors: Chris Dailey/Michael Polyviou                                   EVC Group, Inc.                     (646) 445-4800                       cdailey@evcgroup.com                     

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