Interpace Diagnostics' New Molecular Test for Thyroid Nodules Now Available Through LabCorp
PARSIPPANY, N.J., Jan. 12, 2016 /PRNewswire/ -- Interpace Diagnostics (NASDAQ: IDXG) announced today that Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH), the world's leading health care diagnostics company, will begin offering Interpace's new ThyraMirTM microRNA classifier test. Physicians will be able to order ThyraMir through LabCorp, in addition to Interpace's ThyGenX® oncogene panel, which LabCorp already offers. These innovative assays provide enhanced options for the diagnosis of thyroid cancer in patients with indeterminate thyroid nodules.
Studies show that the combination of the two molecular tests provides unprecedented high sensitivity and specificity, enabling physicians to either rule in or rule out malignancy in thyroid nodules initially deemed indeterminate by standard cytology. In addition to providing more precise diagnostic information, performing the tests together will in many cases eliminate the need for patients to undergo a second fine needle biopsy to collect the specimen typically needed for further tests.
"This agreement with LabCorp expands the reach of our molecular diagnostic tests for indeterminate thyroid nodules, and is a significant step in increasing access to the unmatched benefits of our molecular thyroid products. The ThyGenX and ThyraMir assays will provide physicians with data to help change treatment decisions and will improve the health and lives of patients," commented Jack Stover, Interim Chief Executive Officer of Interpace Diagnostics.
LabCorp is the preferred national laboratory offering ThyGenX and ThyraMir, while Interpace continues to drive sales and marketing, conduct clinical research, and perform the assays in its CLIA certified and CAP accredited laboratory. Customers may contact their LabCorp sales representative for information on how to order ThyGenx and ThyraMir through their existing account.
About Thyroid Nodules, ThyGenX and ThyraMIR
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR. 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 the appropriate course of action.
ThyGenX 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 the test has been upgraded to an 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 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.
About Interpace Diagnostics Group, Inc
Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. The company currently has three commercialized molecular tests; PancraGen for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
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. The company 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 company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause company'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, our ability to adequately finance the business, the market's acceptance of our molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the company'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 the company's Form 10-Q filed with the SEC on November 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, the company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
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SOURCE Interpace Diagnostics Group, Inc.
Released January 12, 2016