PARSIPPANY, N.J., May 14, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced data today from two studies showing that ThyraMIR™, a novel microRNA gene expression classifier combined with ThyGenX™,1 Interpace Diagnostics' genetic mutation panel, provides physicians with a unique solution that offers an unsurpassed negative predictive value (NPV) of 94% and positive predictive value (PPV) of 74% in combination. As a result, using ThyGenX combined with ThyraMIR may potentially result in fewer unnecessary surgeries for patients with previously indeterminate thyroid nodules. These data will be presented as posters at the American Association of Clinical Endocrinologists (AACE) 24th Annual Scientific & Clinical Congress, in Nashville, Tennessee, May 13 – 17, 2015.
In one poster to be presented at AACE, data show that the combination testing for microRNAs and validated oncogenic mutations has high diagnostic specificity. These results suggest the number of benign nodules correctly identified is significantly increased and can therefore potentially decrease unnecessary surgeries. This can further improve pre-operative management of patients with true benign thyroid nodules who previously had an indeterminate cytology reading. A second poster to be presented at AACE confirms that ThyGenX is highly accurate for the sensitive detection of clinically relevant gene mutations and alterations in thyroid nodules, helping physicians to ensure their patients get the right surgery the first time.
"Patients would of course be relieved to hear the outcome of surgery resulting from an indeterminate thyroid biopsy shows the nodule to be benign, or cancer free. Yet, for the majority of these patients, surgery was not needed in the first place. Advances, such as the combination testing regimen using ThyraMIR and ThyGenX, are greatly needed for patients and their physicians facing clinical challenges including how to best manage an indeterminate thyroid nodule," noted Joan Shey, Light of Life Foundation, Inc, an advocacy group that supports people with thyroid cancer, their loved ones and caregivers.
Approximately 525,000 thyroid nodule fine-needle aspiration (FNA) procedures are performed each year in the United States. Up to 35% of thyroid nodules evaluated by FNA and cytopathology do not provide a definitive benign or malignant diagnosis. In many cases, preoperative molecular testing on indeterminate nodules can aid clinicians in ruling in or ruling out thyroid cancer and may reduce the number of unnecessary or suboptimal surgeries. 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 avoid unnecessary surgery on benign nodules, which may occur in 70% to 80% of the cases.
"We are extremely pleased that these data presented during AACE further support the validity of our ThyraMIR and ThyGenX tests and the superior information provided to physicians. Indeterminate thyroid nodules present a formidable clinical challenge and historically have resulted in many unnecessary surgeries. Combination testing using ThyraMIR and ThyGenX can further reduce these unnecessary surgeries as a result of current methods, to, in turn, help patients," said Nancy Lurker, CEO of PDI, Inc. "Furthermore, the data adds to the body of scientific evidence including the recent publication of a pivotal study in The Journal of Clinical Endocrinology & Metabolism that also showed this combination testing can improve detection of benign and malignant thyroid nodules previously diagnosed as indeterminate, which can lead to much better patient care."
The Journal of Clinical Endocrinology & Metabolism manuscript can be accessed at http://press.endocrine.org/doi/abs/10.1210/jc.2015-1158.
Interpace Diagnostics AACE Poster Details and Links
Abstract_1086 – May 15, 2015, 9:45 am CST
COMPREHENSIVE DIAGNOSTIC EVALUATION OF NEOPLASTIC THYROID LESIONS BY NEXT GENERATION SEQUENCING AND MIRNA GENE EXPRESSION
Abstract_1095 – May 15, 2015, 9:45 am CST
ACCURATE DETECTION OF ONCOGENIC MUTATIONS IN THYROID NODULE ASPIRATES WITH THE NEXT GENERATION SEQUENCING THYGENX TEST
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 surgical decision-making for patients with thyroid nodules when standard cytopathology does not provide a clear diagnosis of thyroid cancer. ThyGenX assists physicians in distinguishing between benign and malignant 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 high negative predictive value of 94% and high positive predictive value of 74%. Following fine needle aspiration, combined use of mutation testing and ThyraMIR had an overall sensitivity of 89% and specificity of 85%. 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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1 ThyGenX is adapted and rebranded from Asuragen's miRInform®
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