Interpace Diagnostics Announces First Independent Publication Demonstrating Clinical Utility of BarreGEN®
PARSIPPANY, NJ, Feb. 19, 2019 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today that BMJ Open Gastroenterology, an on-line, peer-reviewed, open access gastroenterology journal dedicated to publishing high-quality medical research from all disciplines and therapeutic areas of gastroenterology, has provided the first independent evidence that BarreGEN®, the Company’s lead pipeline product, performed effectively as a biomarker tool for predicting risk of developing more advanced stages of disease prior to the visible appearance of advanced histology. This is the first publication resulting from work related to the Company’s ongoing Clinical Experience Program (CEP) under which several sites across the country are using BarreGEN to provide input on its clinical utility in a real-world setting. Other sites are expected to report on their results and optimally have them published in similar fashion over the next several months. The study entitled “Mutational Load May Predict Risk of Progression in Patients with Barrett’s Esophagus and Indefinite for Dysplasia: A Pilot Study” was conducted at the Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York and the authors were Trindade AJ, McKinley MJ, and Alshelleh M., et. al.
Management of Barrett’s Esophagus patients who have indefinite levels of dysplasia is challenging due to uncertainty in their risk of progressing to more advanced disease, such as low or high-grade dysplasia. In past studies, BarreGEN’s assessment for genomic instability has been shown to help identify the presence of dysplasia and, moreover, to identify Barrett’s patients at higher risk of developing high grade dysplasia and cancer 4 years prior to visible signs of advanced histology. Findings from this clinical experience study further support the use of BarreGEN as an effective tool at identifying higher risk of progression in patients with indefinite levels of dysplasia at least a year prior to the appearance of dysplasia. They support the use of BarreGEN as a biomarker to identify Barrett’s patients in need of closer surveillance or cancer preventative measures, differentiating them from those in whom unnecessary interventions can be avoided.
In the study, genomic instability was examined using BarreGEN’s mutation load assessment in twenty-eight consecutive patients of whom eight progressed to dysplasia. Mutational load was 100% sensitive and 85% specific in identifying Barrett’s patients as indefinite for dysplasia who would later develop high grade dysplasia. Higher mutational load levels escalated risk of developing high grade dysplasia to 33% and risk of developing any dysplasia to 41%. Comparably, patients who had lower mutational load levels were at less than 10% risk of developing any dysplasia and at 0% of developing high grade dysplasia. Accordingly, these results are supportive of mutational load as a useful biomarker that can help risk-stratify patients with indefinite for dysplasia where risk of advanced disease is more uncertain and additional information is needed to help triage patients.
Jack Stover, President and CEO of Interpace, stated, “We are pleased that such a prestigious institution has published this peer-reviewed study providing the first independent evidence of the clinical utility of BarreGEN in identifying those patients who are likely to progress from Barrett’s Esophagus to more advanced stages of the disease associated with cancer.” Mr. Stover continued, “We are looking forward to additional study results being announced in the near future from our growing CEP related to the performance of BarreGEN in more real-world settings.”
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; 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. 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 10 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, its ability to maintain its NASDAQ listing and the Company’s ability to successfully commercialize BarreGENÒ including collecting clinical data and obtaining reimbursement. 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.
Joseph Green / Wiktoria O’Hare
646-653-7030 / 7028
Released February 19, 2019