Discussing Methods for Securing Coverage and Reimbursement for Molecular Diagnostics
PARSIPPANY, NJ, Aug. 20, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (“Interpace” or “the Company”), a fully integrated commercial and bioinformatics company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, announced today that the Company will present at the 10th Annual Next Generation Dx Summit, being held in Washington, DC from August 22-24, 2018.
As part of the “Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic” track, Interpace’s Chief Commercial Officer, Greg Richard, will host a presentation on how to navigate the disparate technology assessment processes employed by private and public payers and the specific methods Interpace has used to successfully secure coverage for its products, ThyGeNEXT™, ThyraMIR®, PancraGEN®, and RespriDx™. Mr. Richard will also participate on a panel discussing disruptive technologies in lab medicine.
The event track will provide insight into the industry’s ongoing efforts to bring molecular diagnostic assays that will deliver value to patients, physicians, and healthcare systems.
Details of presentations are as follows:
Session Track: Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic
Presentation Title: “Maneuvering Through Disparate Technology Assessment Processes”
Date: Thursday, August 23
Time: 12:45pm – 1:15pm ET
Session Track: Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic
Panel Title: “Disruptive Technologies in Lab Medicine”
Date: Thursday, August 23
Time: 11:20am – 12:00pm ET
Jack Stover, CEO of Interpace, stated, “The Next Generation Dx Summit is an important industry event, bringing together diagnostics professionals to discuss the evolving regulatory and reimbursement landscape. Interpace recognizes the importance of our continued success in this area as we strive to expand coverage of our products and reach more patients around the world.”
For more information on the conference, including the full agenda, visit: www.nextgenerationdx.com
About Thyroid Nodules, ThyGenX® (and now ThyGeNEXT™) 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 for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX®(and now ThyGeNEXT™) and ThyraMIR®.
ThyGenX® (and now 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.
ThyGenX® (and now 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, and through a proprietary algorithm, provides insight of cancer risk. Both ThyGenX® (and now ThyGeNEXT™) and ThyraMIR® are covered by both Medicare and Commercial insurers.
ThyGeNEXT™ is a proprietary new mutational panel for indeterminate thyroid nodules. ThyGeNEXT™ includes numerous additional molecular markers, gene mutations, and RNA fusions compared to ThyGenX®. The new product represents a more comprehensive set of indicators to not only identity malignant or benign nodules, but also ascertain aggressiveness and other characteristics.
About PancraGEN®
PancraGEN® is a molecular, cancer risk classifier for cysts, solid lesions, and biliary strictures that have potential for pancreatic or bile duct cancer and that by using a small sample of fluid or duct brush, can aid in cancer risk assessment. PancraGEN® is 90% accurate according to clinical studies, enabling effective risk stratification of patients with pancreatic cysts. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is one of the leading causes of cancer deaths.
About RespriDx™
RespriDx™ is a molecular test that differentiates between new primary lung tumors and metastasis by identifying the unique molecular fingerprint of a tumor using a series of tumor markers and loss of heterozygosity (LOH). Discerning whether a lung neoplasm is the result of a newly formed tumor or metastasis is useful in determining what course of action physicians should take, e.g. surgery, chemotherapy, etc.
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial and bioinformatics company that provides clinically useful molecular and related first line diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. The Company currently 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; ThyGenX® (currently 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. BarreGEN®, for Barrett's Esophagus, is currently being “soft launched” with key opinion leaders as we continue to gather data on this assay that will assist us in seeking favorable reimbursement as well as important clinical information. Barrett's Esophagus is a rapidly growing diagnosis that affects over three million people in the US, and over time can progress to esophageal cancer. The Company’s data base includes data from over 45,000 patients who have been tested using the Company’s current products, including over 15,000 molecular tests for thyroid nodules. Interpace has been designated by CIO Applications magazine as one of the top 20 companies for providing bioinformatics solutions. Interpace’s mission is to provide personalized medicine through molecular diagnostics, innovation and data to advance patient care based on rigorous science. 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, 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 history of losses, the Company's ability to adequately finance the business, 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 SEC filings, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed on March 23, 2018, Quarterly Reports on Form 10-Q and other SEC filings. 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.