CAMBRIDGE, England--(BUSINESS WIRE)--Population Genetics Technologies Ltd (PGT), a leading developer of diagnostic tests based on unique proprietary technology that greatly enhances the sensitivity of Next Generation Sequencing (NGS), today announced a scientific agreement with Case Western Reserve University in Cleveland Ohio. The company will work closely with Dr. Miguel Quiñones-Mateu, Assistant Professor in the Department of Pathology and Scientific Director of the University Hospitals Translational (CLIA/CAP certified) Laboratory. The focus of the research will be the further development of diagnostic tests to determine HIV drug resistance for use in clinical management of HIV positive patients.
Resistance to anti-retroviral therapies is a major issue in the treatment of HIV positive patients, and the main reason why anti-retroviral treatment fails. Although anti-retroviral drugs slow the replication of HIV in the body, some virus survives in a latent form, and the high mutability of HIV can lead to the development of drug resistance mutations in the HIV genome. If resistance develops, usually the drug regimen needs to be changed, and the earlier this is done the better for patient outcomes and healthcare costs.
NGS, which enables sensitive detection of mutations, is driving a major transformation in infectious disease diagnostics and is rapidly moving into routine clinical practice. Standard sequencing tests for HIV drug resistance only detect a mutation that is present in at least 20% of viruses; NGS alone can detect resistance mutations down to the 1 - 5% level. However, even this level of detection may be insufficient for clinical use, as mutations at lower levels can lead to development of drug resistance. To overcome this limitation, PGT has developed its revolutionary VeriTag™ technology, which enhances the power of NGS and enables the confident assessment of mutations in pathogen populations at a 0.1% level, allowing early detection of resistant mutations.
PGT is developing and will market a portfolio of VeriTag™ based NGS diagnostic tests for clinical applications in human infectious disease. The diagnostic tests will be FDA/CE regulatory approved kits with full cloud-based data analysis, data management, and clinical reporting. The initial diagnostic kits will target the HIV and HCV drug resistance monitoring markets, where the VeX-HIV™ and VeX-HCV™ assays with VeriTag™ technology will confer clear clinical advantages over existing commercial and emerging NGS assays. Subsequent tests will target antimicrobial resistance in healthcare-associated infections to guide therapy more effectively.
“We are delighted to have access to the expertise of Dr. Miguel Quiñones-Mateu, who brings enormous technical expertise and success in the development and validation of infectious disease diagnostics to our organization,” said Dr. Alan Schafer, Chief Executive Officer of PGT. “His skills and knowledge will add greatly to the capabilities of the company, and enable us to accelerate our product development program”.
Dr. Miguel Quiñones-Mateu’s research work focuses on understanding the mechanisms and clinical consequences of drug resistant viruses, including transmission and pathogenicity studies, using state-of-the-art next generation sequencing technology.
“Despite the success of current antiretroviral therapy, it is difficult to durably control HIV replication in part because of the extraordinary capacity of the virus to develop resistance to antiretroviral drugs. Detection of the development of resistance at the earliest possible time is critical for optimal clinical management of HIV infection”. Dr. Miguel Quiñones-Mateu added, “This research brings together the expertise of my laboratory together with the capabilities of PGT, and will enable rapid progress in the development of commercially useful diagnostic tests”.
About Population Genetics Ltd
Population Genetics Technologies (PGT) is dedicated to creating cost-effective, accurate, sensitive, rapid and easy-to-use next generation sequencing tests for infectious diseases that will allow health professionals to administer the right antivirals and antibiotics at the right time. Building on its proven scientific and commercial expertise in NGS assay technologies, PGT is developing a portfolio of US and European regulatory approved tests for use in clinical testing laboratories which deliver reports to guide clinical management.
About Case Western Reserve University School of Medicine
Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation’s top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School’s innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the School of Medicine.
Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report’s “Guide to Graduate Education.”
The School of Medicine’s primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002.