FDA Clearance for Fl...
13th May 2019 Content supplied by: Arc Bio, LLC
GPS-Transplant - NGS for Monitoring Post-Transplant Patients for Viral Infections
With the current standard of real-time quantitative PCR (qPCR) technology, only one virus can be detected per test, despite there being hundreds of different viral strains that can infect transplant patients. GPS-Transplant is one comprehensive test able to detect the most common viral infections among transplant patients – including Cytomegalovirus (CMV), Epstein–Barr virus (EBV), BK virus (BKV) and human adenovirus (hADv) – and their variances and genotypes, as well as rarer infections. GPS-Transplant offers the ability to detect antiviral resistance mutations, coupled with simultaneous quantitative detection of greater than 350 viral strains.
GPS-Transplant will initially be made available as a Research Use Only test that laboratories can purchase and validate in their own laboratories as a Laboratory Developed Test.
At a workshop at CVS on enabling NGS-based metagenomics in the clinical virology laboratory, Benjamin Pinsky, MD, PhD, Medical Director of Clinical Virology at Stanford Healthcare & Stanford Children's Health, will present data from his study of GPS-Transplant in immunocompromised patients.
"My team observed near perfect agreement between samples quantified by both qPCR and the Galileo™ Pathogen Solution," Pinsky said. "By using Galileo™ my team was also able to identify a number of viruses that were not initially tested by the clinical teams."
Data from two additional studies will also be presented at CVS. "The ability to transform metagenomic data into a titer and compare accurately with singleplex qPCR assays is outstanding and completely novel in this field," said Judith Breuer, MD, Professor of Virology at University College London and Honorary Consultant Virologist at Great Ormond Street Hospital for Children NHS Trust, whose team will present one of these studies. "We have used metagenomics for the past two years in my laboratory, the development and introduction of which was relatively complex and time consuming. Arc Bio's out-of-the-box concept certainly brings advantages to laboratories who wish to evaluate this cutting-edge technology but who don't have the expertise to do this alone."Galileo™ Pathogen Solution provides healthcare professionals with a research tool that gives them the power to perform sophisticated pathogen analyses without requiring bioinformatics expertise. It is a sample-to-report solution built around the Illumina NGS platform that consists of reagents, built-in assay controls, and Galileo™ Analytics, a cloud-based proprietary software that provides quick and reliable results, an intuitive user interface, and detailed, actionable reports. Galileo™ Analytics leverages Arc Bio's highly curated pathogen database (ArcIve) and also incorporates the best-in-class Galileo™ AMR resistance prediction technology launched in 2018.
Date Published: 13th May 2019
Source article link: View
Cherwell Laboratories Cleanroom Microbiology Solutions
FDA Clearance for FluChip-8G