OpGen Inc, Gaithersburg, Md, has received Clinical Laboratory Improvement Amendments (CLIA) certification and has launched a clinical services lab with a focus on developing a portfolio of genetic tests and analysis services for the surveillance and identification of health care associated infections (HAIs) and human pathogens.
With the opening of the CLIA-certified lab, OpGen will provide a comprehensive offering of infectious disease screening, diagnostic and epidemiology services.
Two million patients a year (10% of all hospitalized patients) contract an infectious disease while in the hospital.1 HAIs are the fourth leading cause of death in the United States, with 100,000 deaths annually.1
The company’s clinical services lab uses next-generation DNA and genetic analysis technologies that include multiplex real-time PCR, whole genome mapping, and next-generation sequencing, enabling it to provide low cost, genetic testing for screening, surveillance, diagnosis, gene content, and epidemiologic analysis of infectious diseases.
OpGen offers whole genome mapping genetic analysis of HAIs, as well as sequence analysis of C. difficile on a worldwide basis. It will offer real-time PCR screening and surveillance of MRSA and complete C. difficile hyper-virulence diagnostic testing services in the mid-Atlantic region. OpGen is actively developing tests for a broad array of gram-negative and gram-positive multi-drug resistant organisms.
Sources:
1. Centers for Disease Control and Prevention (CDC), HAIs The Burden, updated 2010
[Source: OpGen]
