OpGen, Inc., a leading genetic analysis company, has received Clinical Laboratory Improvement Amendments (CLIA) certification and launched a clinical services laboratory with a focus on developing a best-in-class portfolio of genetic tests and analysis services for the surveillance and identification of healthcare associated infections (HAIs) and human pathogens.

“With the significant mortality and costs associated with HAIs along with growing prevalence and concerns surrounding multi-drug resistant organisms, clinicians, hospitals and public health agencies need to be able to rapidly identify healthcare associated infections to effectively treat patients while minimizing the risk of outbreaks,” said Douglas White, chief executive officer of OpGen, Inc. “OpGen is building on the success of our Whole Genome Mapping applications in the public health and life sciences sectors to expand our capabilities to help hospitals and healthcare facilities combat HAIs and complex human pathogens. With the opening of our CLIA-certified laboratory, OpGen will provide a unique, comprehensive offering of infectious disease screening, diagnostic and epidemiology services.”

Two million patients a year (10 per cent 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 Drug-resistant pathogens are a growing global crisis with multi-drug resistant (MDR) gram-negative infections increasing in virulence and prevalence in US hospitals. Not only are HAIs a growing public health threat, but they cost the US healthcare system $40 billion dollars in 2009.1 Currently available diagnostic tests are often limited in their capabilities, too expensive, too complex or not routinely available.

OpGen’s clinical services laboratory utilizes next generation DNA and genetic analysis technologies that include multiplex real-time PCR, Whole Genome Mapping and next generation sequencing. This comprehensive suite of capabilities enables OpGen 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. Additionally, the company will offer real-time PCR screening and surveillance of MRSA and complete C. difficile hyper-virulence diagnostic testing services in the mid-Atlantic region. The company is actively developing tests for a broad array of gram-negative and gram-positive multi-drug resistant organisms.