PARSIPPANY, N.J., July 6, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary Interpace Diagnostics announced today that effective June 2015, ThyGenX™,i the company's genetic mutation panel, has been approved by Aetna for assessing fine needle aspiration (FNA) samples from indeterminate thyroid nodules. Aetna's coverage decision now means that ThyGenX is considered medically necessary. Aetna covers 46 million lives and its positive coverage decision brings the total number of lives covered for ThyGenX to more than 100 million.
Approximately 15-30% of the 525,000 thyroid FNA's performed on an annual basis are indeterminate based on standard cytological evaluation, and thus are candidates for ThyGenX. ThyGenX has been validated in a prospective, clinical study involving over 600 patients and has a specificity rate of 89%.ii
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 appropriate.
According to Nancy Lurker, PDI's CEO, "Aetna's decision results in the first major commercial coverage for ThyGenX and it continues to affirm the value that ThyGenX offers to patients with indeterminate cytology for thyroid FNAs. We are pleased that Aetna's members now have access to ThyGenX, a test already validated through peer-reviewed publications and that can help reduce unnecessary thyroid surgeries."
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.
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 which provides greater genomic insights and increased panel content.
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.
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i ThyGenX is adapted and rebranded from Asuragen's miRInform®
ii Labourier, Emmanuel et al. The Journal of Clinical Endocrinology & Metabolism (2015): jc-2015.http://press.endocrine.org/doi/abs/10.1210/jc.2015-1158. Accessed July 1, 2015.
SOURCE PDI, Inc.