HEMATOGENIX LABORATORY SERVICES, LLC (Hematogenix)RECEIVES ACCREDITATION FROM COLLEGE OF AMERICAN PATHOLOGISTS
TINLEY PARK, IL, December 20, 2016 – The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Hematogenix®, Alderley Park, United Kingdom, based on results of a recent on-site inspection as part of the CAP’s Accreditation Programs.
The facility’s director, Hytham Al-Masri, M.D., CEO was advised of this national recognition and congratulated for the excellence of the services being provided. Hematogenix is one of more than 7,700 CAP-accredited facilities worldwide.
“We are pleased to announce the CAP accreditation for our laboratory in the United Kingdom. Our accreditation reflects our consistent approach to providing quality testing in all aspects of our business. We strive to deliver the same levels of service at each of our facilities and today this is truly reflected by the CAP recognition,” said Dr. Al-Masri.
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, which is 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.
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.
About Hematogenix Laboratories
Hematogenix is a CAP/CLIA-certified laboratory with a full complement of board-certified clinical, anatomic and research pathologists to provide consultation and guidance for all aspects of their pharma and diagnostic services. The company offers a comprehensive array of biomarker development and testing services designed to navigate the complexities of human subject clinical trials. Hematogenix provides logistics management of tissue and sample procurement, distributes collection kits, and contributes to standards and procedures required for initiating a clinical trial. Powered by a state-of-the-art laboratory information system, Hematogenix complies with rigorous chain-of-custody and specimen-management practices. Visit Hematogenix.com to learn more.
Kathryn E. Evans
Hematogenix Laboratory Services LLC – The First Diagnostic Testing and CLIA-Certified Biomarker Services Laboratory to Offer Advanced Cell Diagnostics, RNAscope® Assays to Clients
TINLEY PARK, Ill., Nov. 25, 2013 /PRNewswire/ — Hematogenix Laboratory Services (Hematogenix), a leader in the field of integrated pathology services for drug development and clinical testing, today announced the availability of the Advanced Cell Diagnostics’ (ACD) RNAscope® technology on an automated platform. Hematogenix is the first laboratory to offer automated RNAscope ISH for both Pharma Services and Diagnostic Services. “Hematogenix’s core expertise of pathology synergizes strongly with the RNAscope® platform, allowing us to elucidate valuable information from patient tissue specimens,” said Dr. Hytham Al-Masri, CEO and Medical Director of Hematogenix.
RNAscope® enables the detection of mRNA by in situ hybridization (ISH). In situations when immunohistochemistry fails to detect the analyte, “RNAscope® may be the only viable test,” comments Dr. Jason Hill, CSO at Hematogenix. “This technology provides the drug developer or the physician an alternative method to identify and quantify any analyte in formalin-fixed, paraffin-embedded material.” The scientists at Hematogenix successfully demonstrated the detection of PD-L1 in human tissue specimens on their automated platform, a very attractive immunotherapy target for the pharmaceutical industry. Automated IGK/L assays for light-chain restriction (LCR) lymphoma testing will soon be validated according to (or per) CLIA requirements, as well. “We are confident that this automated technology, when deployed with the pathology expertise of Hematogenix in our CLIA laboratory, will prove valuable in numerous clinical trial and testing settings,” adds Dr. Al-Masri.
Advanced Cell Diagnostics recently introduced the CLIA Certified RNAscope® Service Provider program. This program is designed to enable CAP/CLIA laboratories to support clinical trials for ACD’s leading pharmaceutical clients and to ensure delivery of high quality pathology testing services. Each service provider receives extensive training on RNAscope technology and is required to pass a rigorous certification procedure. “Hematogenix has proven itself in clinical pathology testing, translational research and PMA-class companion diagnostic development. Their clients speak highly of their capabilities and it speaks well of our automated RNAscope platform deployed by Hematogenix,” said Dr. Yuling Luo, Founder, President and CEO of ACD.
About Hematogenix Laboratories
Hematogenix is a CAP, CLIA certified laboratory with a full complement of board certified clinical, anatomic and research pathologists to provide consultation and guidance for each Pharma project. The company offers a comprehensive array of biomarker development and testing services designed to navigate the complexities of human subject clinical trials. Hematogenix provides logistic management of tissue and sample procurement distributes collection kits and contributes to standards and procedures required for initiating a clinical trial. Powered by a state-of-the-art laboratory information system, Hematogenix facilities and practices comply with rigorous chain of custody and specimen management practices. Learn more about Hematogenix biomarker services at www.hematogenix.com.
About Advanced Cell Diagnostics, Inc.
Advanced Cell Diagnostics, Inc. is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA in situ hybridization, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.