Clinical Data Highlights the Utility of ThyGeNEXT® and ThyraMIR®
PARSIPPANY, NJ, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Interpace Group (NASDAQ: IDXG) Interpace Diagnostics announced today the publication of two peer-reviewed journal articles and one textbook chapter supporting the clinical utility of ThyGeNEXT® when used alone and in combination with ThyraMIR®.
The most recent article was published in Diagnostic Cytopathology in a paper called “Incremental Utility of Expanded Mutation Panel When Used in Combination with MicroRNA Classification in Indeterminate Thyroid Nodules”. The study is now published on the Diagnostic Cytopathology website at https://doi.org/10.1002/dc.24328 and compares results of ThyGenX®, Interpace’s first-generation mutation panel, with ThyGeNEXT®, Interpace’s expanded second-generation mutation panel, showing that the expanded panel provides additional utility when used in combination with ThyraMIR®, Interpace’s microRNA risk classifier. The study concludes that expansion of the panel increases detection of mutations and fusions strongly associated with malignancy and aggressive thyroid cancer, increasing the panel’s utility in surgical decision making. Furthermore, the panel expansion also increases detection of less aggressive mutations also associated with malignancy, where ThyraMIR® plays a key role in providing additional risk stratification.
An independent peer-reviewed journal article has been published in the Journal of Otolaryngology related to a study lead by Dr. Rick Payne from McGill University, Montreal, QC, Canada. The article entitled “Molecular Mutations as a Possible Factor for Determining Extent of Thyroid Surgery” concluded that markers in Interpace’s ThyGeNEXT® may be useful in identifying aggressive thyroid tumors, assisting in the planning and timing of surgery for patients.
In addition, Interpace’s pathologist, Dr. Tina Narick contributed to a chapter entitled “Application of Molecular Tests in Indeterminate Thyroid FNA” in the Atlas of Thyroid Cytopathology on Liquid-Based Preparations. The chapter reviews the performance and utility of molecular testing on thyroid aspirates and specifically includes detailed information on ThyGenNEXT® and ThyraMIR® performance, with discussion of various specimen types including cytology slides. Importantly, it describes results of a comparison between ThyGeNEXT® and ThyGenX®, indicating 100% concordance between test results and the identification of additional markers of aggressive cancer using ThyGeNEXT®,
According to Jack Stover, Interpace’s CEO, “These publications provide further evidence of the clinical utility of our molecular products for thyroid cancer.” In addition, he stated, “our accumulation of data helps validate our claims with insurance companies who are effectively the gate keepers for patients needing our expertise.”
About Thyroid Nodules, ThyGeNEXT® and ThyraMIR® Testing
According to the American Thyroid Association, approximately 20% 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 ThyGeNEXT® and ThyraMIR®.
ThyGeNEXT® 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.
ThyGeNEXT® 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® is the first 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. Both ThyGeNEXT® and ThyraMIR® are covered by both Medicare and Commercial insurers, with more than 280 million patients covered.
About Interpace
Interpace is a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
Interpace’s Diagnostic Business is a fully integrated commercial and bioinformatics business unit that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has four commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR® for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX® that differentiates lung cancer of primary vs. metastatic origin. In addition, BarreGEN® for Barrett’s Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN® to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.
Interpace’s Biopharma Business provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. The Biopharma Business also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.
For more information, please visit Interpace’s website at www.interpacediagnostics.com.
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. 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 10Q. 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.
CONTACTS:
Investor Relations - Edison Group
Joseph Green
(646) 653-7030
jgreen@edisongroup.com