PARSIPPANY, N.J., Oct. 21, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced new data presented at the 15th International Thyroid Congress and 85th Annual Meeting of the American Thyroid Association (ITC/ATA) this week in Lake Buena Vista, Florida (www.ITC2015.thyroid.org) demonstrating that combination testing by ThyGenX®, oncogene panel, and ThyraMIR™, microRNA classifier, has been analytically validated on fixed nodule specimens including Formalin Fixed Paraffin Embedded (FFPE) samples, cytology slides and Thin Prep slides, in addition to the current molecular analysis of fine needle aspirations (FNAs). The ability to analyze fixed thyroid samples now allows for molecular evaluation of older archived samples. An additional benefit is that this expanded menu of molecular testing on cytology slides and Thin Prep sample types can potentially eliminate the need for a second needle pass during patient biopsy.
Results of a second study presented further validates the utility of the combined tests ThyGenX oncogene panel using Next Generation Sequencing (NGS), and ThyraMIR miRNA classifier. When used in combination, ThyGenX and ThyraMIR synergistically show performance improvements over each test individually. This results in increased diagnostic sensitivity which in turn improves the preoperative diagnosis of thyroid nodules with indeterminate cytology.
According to Nancy Lurker, PDI's CEO, "We are pleased to announce this growing body of evidence supporting the power of our thyroid nodule combination testing. In addition, the analytical validation supporting the evaluation of FFPE and cytology slides will mean more widespread thyroid nodule molecular testing will be available to physicians and patients. As a result of these data we plan to offer commercial cytology testing services in the near future as we continue to expand our diagnostic offerings."
Interpace Diagnostics ITC/ATA Poster Details and Links
Session Dates/Times For Both Posters:
Wednesday, October 21, 2015, 9:00 am EST
Thursday, October 22, 2015, 9:00 am EST
All posters will remain up for two days starting Wednesday, October 21 at 9:00 am EST through Thursday, October 22 1:30 pm EST.
About PDI, Inc. and Interpace Diagnostics
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 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.
Guidelines from the National Comprehensive Cancer Network (NCCN) indicate that molecular diagnostic approaches may be useful in the evaluation of thyroid Fine Needle Aspirate (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 appropriate. Approximately 15-30% of the 525,000 thyroid FNAs performed in the U.S. on an annual basis are indeterminate based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR™.
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.
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 August 14, 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.
SOURCE PDI, Inc.