VICTORIA, British Columbia, Oct. 18, 2017 (GLOBE NEWSWIRE) — Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, announced today the presentation of new data based on actual clinical results for 3,471 patients tested with the Company’s ThyGenX® /ThyraMIR® molecular tests for indeterminate thyroid nodules at the annual meeting of The American Thyroid Association (ATA) being held October 18-22, 2017 in Victoria, British Columbia. Over 5,000 Endocrinologists, Endocrine Surgeons, and numerous other providers who focus on endocrinology attend this annual event.
The presentation at the ATA meeting is entitled “The Utility of Combined Mutations and MicroRNA Expression Profiling in Assessing Cancer Risk in Thyroid Nodules.” In addition to several Company clinicians and researchers, the authors included Dr. Jan Silverman from the Department of Pathology at Allegheny General Hospital, Pittsburgh, PA.
The study in summary strongly supported the combined approach of mutational panels and microRNA analysis that we use in our ThyGenX and ThyraMIR assays. The primary conclusion reached in the study was that mutational change is not sufficient to risk stratify thyroid nodular disease unless accompanied by attention to clinical, imaging and additional molecular findings and that miRNA classification complements cytology and mutational analysis with the capacity to better predict the biological aggressiveness of tumors. In addition, the results supported previous conclusions regarding the performance of combination mutational panels combined with miRNA classifier testing based on a large cohort of patients tested clinically in a real-world setting. Further, the data extended prior results to include a four-tier miRNA approach that further improves sensitivity and specificity for malignancy, which in turn further improves the predictive value of combination mutational panel and miRNA classifier testing. Importantly, use of our four-tier miRNA classifier stratifies cancer risk in patients with RAS mutations and in those who lack all mutations, providing opportunities to further personalize patient care.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased that the ATA found this new data compelling enough to accept it for presentation during this highly regarded conference. This data comprised of test results from a significant number of patients is further evidence of the strong clinical utility of ThyGenX and ThyraMIR.”
About Thyroid Nodules, ThyGenX and ThyraMIR testing
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 for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes 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 cancer. ThyraMIR was the first microRNA gene expression classifier made commercially available. 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. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in 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; and MVPdx for identifying recurring tumors in the same organ vs. metastasis from another organ. Interpace Diagnostics’ mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
About the ATA
The American Thyroid Association is one of the largest specialty physician organizations focused on enhancing the science around the diagnosis and treatment of endocrine related diseases. Focusing on a wide range of diseases, from diabetes to thyroid cancer, the Association is comprised of physicians including Endocrinologists, Endocrine Surgeons, Diabetologists, Nutritionists, Nurse Practitioners, specialty laboratories, and other providers.
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 the Company’s 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 the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the 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, the Company’s ability to adequately finance the business, its ability to restructure its liabilities and other obligations, the market’s acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and its ability to maintain its NASDAQ listing.. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
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.
Interpace Diagnostics Group, Inc.
Paul Kuntz – Redchip