Interpace Diagnostics Group, (NASDAQ:IDXG)
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3 Months : From Apr 2019 to Jul 2019
Pennsylvania and Connecticut Labs Both Receive Accreditation
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today that it has received the College of American Pathologists (“CAP”) accreditation for its Pittsburgh, Pennsylvania and New Haven, Connecticut laboratories. Only after the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) designation has been received can a laboratory apply for the more rigorous CAP accreditation. To qualify and remain compliant, every two years a peer group of inspectors thoroughly examine the lab’s records, quality control procedures, staff qualifications, equipment, facilities, safety program, and overall management ensuring that the highest, industry-specific standards are upheld.
The Pittsburgh location serves as the Company’s largest laboratory and provides a wide variety of services including cytology, molecular testing, and pathology for the PancraGEN®, ThyGeNEXT®, ThyraMIR®, RespriDx®, and BarreGEN® assays. The New Haven lab provides services for both the commercial molecular thyroid assays along with all testing associated with clinical development and research activities.
Jack Stover, President and CEO of Interpace Diagnostics, stated, “We are pleased to have once again obtained accreditation from CAP for both of our labs, demonstrating our commitment to operating within the highest industry standards.”
About Interpace Diagnostics Group
Interpace is a fully integrated commercial and bioinformatics 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 improved patient diagnosis and management. Interpace’s mission is to provide personalized medicine through molecular diagnostics, innovation and data to advance patient care based on rigorous science. 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. 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 50,000 patients who have been tested using the Company’s current products, including over 25,000 molecular tests for thyroid nodules. Interpace has been designated by the 2018 edition of CIO Applications 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.
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at cap.org.
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 fact that success in clinical studies may not be replicated in later studies or demonstrate the clinical utility of the test, the market's acceptance of its molecular diagnostic tests and the Company’s ability to retain and secure reimbursement among other things. 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.
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