Interpace Diagnostics Announces Expansion Into New Clinical Area With Launch Of Molecular Lung Cancer Test
Published: Sep 25, 2017
PARSIPPANY, N.J., Sept. 25, 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 launch of a new lung cancer test, MVPdX™, that differentiates the local recurrence of cancer versus new primary cancer formation. It compares the mutational fingerprint of two or more sites of lung cancer to determine whether the neoplastic deposits are representative of a recurrence of cancer or a new primary (independent) cancer.
MVPdX helps define the primary site of formation of lung cancer in relationship to multiple sites of metastatic spread and helps differentiate multi-centric carcinoma from intra-organ spread of one cancer. The test is based on an analysis of loss of heterozygosity using a panel of microsatellite markers in proximity to 16 tumor suppressor genes. Various peer reviewed publications support the use of mutational profiling for this purpose including “Comparative Mutational Profiling in the Assessment of Lung Lesions: Should it be the Standard of Care?” (Annals of Thoracic Surgery, 2010). According to Dr. Jan F. Silverman, System Chair, Department of Pathology and Laboratory Medicine at the Allegheny Health Network, “We have found this testing to be invaluable since it can affect the staging of the patient and treatment decisions.”
Importantly, the MVPdX test is already covered by the Company’s Medicare Administrative Carrier as well as numerous commercial carriers.
According to the American Cancer Society, lung cancer represents the second highest number of new cancer diagnoses in the U.S. for both men and women after prostate and breast cancer, respectively. However, it represents the highest number of deaths for both men and women, with over 220,000 deaths per year.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “This represents a significant milestone for the Company as we expand our menu to include an entirely new vertical line of business in lung assays using our already proven technology. We believe this initiative will further diversify our product offering while potentially providing for further expansion of our revenues.”
About Lung Cancer
According to the American Cancer Society, over 220,000 deaths each year are due to lung cancer. The incidence rate has been declining since the mid- 1980’s in men, but only since the mid 2000’s in women, because of gender differences in historical patterns of smoking uptake and cessation. From 2004-2013, lung cancer incidence rates decreased by about 2% per year in men and 1% per year in women. Lung cancer is typically not diagnosed until it is advanced. Screening with low-dose spiral computed tomography (LDCT) has been shown to reduce lung cancer mortality by about 20% compared with standard chest x-ray. The American Cancer Society guidelines for the early detection of lung cancer endorse a process of informed and shared decision making between clinicians who have access to high volume, high quality lung cancer screening programs and current or former smokers. Appropriate treatment for lung cancer is based on whether the tumor is small cell (13%) or non-small cell (84%), as well as other tumor characteristics. The 5-year relative survival rate for lung cancer is 15% for men and 21% for women. Only 16% of lung cancers are diagnosed at a localized stage, for which the 5-year survival is 55%.
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial 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. Interpace’s mission is to provide personalized medicine through molecular diagnostics and innovation 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. 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 filings with the SEC, including without limitation, the Annual Report on Form 10-K filed with the SEC on March 31, 2017 and the amendment on Form 10-K/A filed on April 28, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the SEC on May 12, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 filed with the SEC on August 10, 2017 and the Company’s Registration Statement on Form S-1, as amended (333-218140), initially filed with the SEC on May 22, 2017. 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.
Paul Kuntz – RedChip