Interpace Diagnostics Labs Receive College of American Pathology (CAP) Accreditation
April 25 2019 - 6:55AM
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.
CONTACTS:Investor Relations - Edison
GroupJoseph Green(646) 653-7030jgreen@edisongroup.com
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