Important Achievements Validate OmniSeq’s High Quality Laboratory Practices and Immune Report Card Assay
buffalo, ny – NOVEMBER 9, 2017 – OmniSeq, Inc., a molecular diagnostics subsidiary of the 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.
OmniSeq, 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 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.
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