CLEVELAND --University Hospitals (UH) Case Medical Center has signed an agreement with Advanced Biological Laboratories (ABL), an information technology and diagnostic company based in Luxembourg, to join efforts on the designing and validation of an HIV drug resistance and tropism assay based on next-generation sequencing (NGS).
Under the agreement, UH will begin using ABL's DeepChek® analysis software with DEEPGEN™HIV, the HIV diagnostic test invented at University Hospitals' Translational Laboratory by Miguel Quinones-Mateu, PhD, Scientific Director at the UH lab and Assistant Professor at the Department of Pathology, Case Western Reserve University School of Medicine. The new test will be offered as "DEEPGEN™HIV, powered by DeepChek®."
The combined DEEPGEN™HIV/ DeepChek® test will aid monitoring the success of anti-HIV treatment by determining drug resistance and the ability of the virus to infect different cells based on deep genetic sequencing. It will also provide a sensitive platform for HIV physicians and researchers, both in the academia and industry, to detect minority variants at frequencies unimaginable with standard HIV genotypic tests based on Sanger (population) sequencing.
"Although the clinical relevance of these minority members of the viral population is still under debate, it is reasonable to assume that the earlier these mutant viruses are detected, the sooner the proper strategy can be defined to control their growth," said Dr. Quiñones-Mateu. "DEEPGEN™HIV is now the primary HIV genotyping assay used by HIV physicians at the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit, and it is being distributed nationally by a major clinical laboratory. This agreement with ABL will expedite the use of this innovative and highly sensitive assay worldwide, which will allow us to enhance the care and treatment of HIV-infected individuals around the globe."
"I am excited about our relationship with ABL, as it appears to be a natural synergy that we both may leverage to expand the quality of diagnostic testing and care provided to patients with HIV internationally," said Ronald E. Dziedzicki, Chief Operating Officer at UH Case Medical Center.
"Our relationship with UH Case Medical Center enables ABL to offer an innovative and potential game changer HIV assay," said Chalom Sayada, PhD, ABL's Chief Executive Officer. "Similarly to how ultra-sensitive HIV viral load introduced an entirely new concept to manage and monitor HIV patients under treatment, the combined DEEPGEN™HIV/ DeepChek® test, by facilitating the analysis of minor and major variant viral populations, could radically improve HIV patient disease management. We are very pleased to include this agreement as part of our strategy and industrial efforts in the US market and worldwide."
About University Hospitals
University Hospitals, the second largest employer in Northeast Ohio with 25,000 employees, serves the needs of patients through an integrated network of 15 hospitals, 28 outpatient health centers and primary care physician offices in 15 counties. At the core of our $3.5 billion health system is University Hospitals Case Medical Center, ranked among America's 50 best hospitals by U.S. News & World Report in all 12 methodology-ranked specialties. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation, including cancer, pediatrics, women's health, orthopaedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. For more information, go to http://www.
About University Hospitals Translational Laboratory
In July 2011, UH Case Medical Center created the UHTL with the goal of advancing and further developing new molecular diagnostic methodologies originally conceived in the academic and clinical laboratories at University Hospitals Case Medical Center and Case Western Reserve University. UHTL's main objective is to facilitate the development of translational research into commercial assays or products, including characterization, verification, and validation in a College of American Pathologists and Clinical Laboratory Improvement Act (CAP/CLIA) certified environment under a Good Laboratory Practice (GLP) framework.
About Advanced Biological Laboratories
Advanced Biological Laboratories (ABL), S.A., is a Medical Data Technology and Diagnostic company founded in 2000 as a spin-off from CRP-Santé Luxembourg. ABL took control of TherapyEdge, Inc. in 2004 and in 2013 acquired the rights to all viral hepatitis B & C related assets from EVIVAR MEDICAL, respectively. ABL has a comprehensive suite of healthcare management products, including TherapyEdge®, ViroScore®, SeqHepB, DeepChek®, VisibleChek®, HepatiC™ and the DPM which are used for data and patient management, monitoring and personalized reporting applications. In 2012, some of ABL's products also received CE-marking for IVD use.
ABL's products, ViroScore® Suite and DeepChek®, are for research use only in the United States, and the upcoming data processing module (DPM) is an FDA registered class I medical device. ABL's products offer infectious disease clinicians and virology laboratories optimal and efficient IT solutions, for sequencing, clinical genotyping, and drug resistance analysis, including powerful fully integrated databases and analysis systems combining standard and high-throughput Next Generation Sequencing data. For more information, go to http://www.