OmniSeq Receives CAP Accreditation and Publishes Analytical Validation Paper
November 09 2017 - 8:02AM
OmniSeq, Inc., a molecular diagnostics subsidiary of Roswell Park
Cancer Institute, announced today that it received accreditation by
the College of American Pathologists (CAP), meeting the highest
standard in excellence in clinical laboratory practices. The
company also announced the publication of its analytical validation
of a next-generation sequencing (NGS) immune response assay in the
Journal of Molecular Diagnostics.
The U.S. federal government recognizes the CAP Laboratory
Accreditation Program, begun in the early 1960s, as being equal-to
or more-stringent-than the government’s own inspection
program. During the CAP accreditation process, designed to
ensure the highest standard of care for all laboratory patients,
inspectors examine the laboratory’s records and quality control of
procedures for the preceding two years. CAP inspectors also examine
laboratory staff qualifications, equipment, facilities, safety
program and record, and overall management.
“CAP accreditation provides additional validation of the
strength and robustness of our internal laboratory processes and
procedures and is an important seal of quality, especially for our
clinical and pharmaceutical customers,” said Dr. Carl Morrison,
OmniSeq’s founder, President and CSO. “We are proud to align with
LabCorp and other laboratories around the globe that support the
CAP accreditation program.”
OmniSeq® offers a variety of next-generation sequencing assays
approved by New York State’s Clinical Laboratory Evaluation Program
(CLEP), including the company’s Immune Report Card SM and OmniSeq
Comprehensive SM clinical assays. In August, OmniSeq
announced that it entered into an exclusive distribution agreement
with LabCorp® (NYSE:LH), a leading global life sciences company,
for the distribution of its Immune Report Card SM and OmniSeq
ComprehensiveSM clinical assays.
Last month, the Journal of Molecular Diagnostics published the
“Analytical Validation of a Next-Generation Sequencing Assay to
Monitor Immune Responses in Solid Tumors.” The paper
describes the multi-analyte NGS component of OmniSeq’s Immune
Report Card to quantify biomarkers of the host immune response in
formalin-fixed, paraffin-embedded (FFPE) tumor specimens.
Jeffrey Conroy, OmniSeq’s Senior Vice President of Technology
Development and first author on the paper, said: “We are pleased to
publish this important analytical validation through the
prestigious and influential Journal of Molecular Diagnostics.
Using a validated NGS and single analyte approach, OmniSeq’s Immune
Report Card provides clinicians with a comprehensive
characterization of the immunological tumor microenvironment to
guide therapeutic selection for patients with solid tumor
cancers.”
The paper can be found at the following link:
http://jmd.amjpathol.org/article/S1525-1578(17)30363-X/fulltext
To learn more about Immune Report Card or OmniSeq Comprehensive,
call 1-800-781-1259 or visit www.omniseq.com.
About OmniSeqOmniSeq, an innovation of Roswell
Park Cancer Institute, is a molecular diagnostic laboratory based
in Buffalo, New York. OmniSeq endeavors to find the right drug or
the right trial for every patient by improving access to better
cancer treatment options through molecular profiling. OmniSeq
offers two NGS-based assays: Immune Report CardSM and OmniSeq
ComprehensiveSM. OmniSeq is proud to partner with academic
researchers and pharmaceutical companies to support immuno-oncology
diagnostics. For more information, call 1-800-781-1259 or
visit www.omniseq.com.
About the College of American PathologistsAs
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.
Contact Information:Matt KlusasChief Commercial
OfficerOffice: +1.716.898.8684Matthew.Klusas@omniseq.com
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