New OS for Molecular HIV-1 Testing Systems

A new operating system (OS) for molecular human immunodeficiency virus (HIV)-1 testing increases patient data storage, expands patient-data management capabilities, accelerates sequencing capabilities, and advances customized reporting functionalities.

The Trugene HIV-1 genotyping kit and OpenGene DNA sequencing system, which were introduced more than ten years ago, provide a clinically validated, U.S. Food and Drug Administration- (FDA; Rockville, MD, USA)-cleared method for monitoring HIV-1 resistance in patients, and their response to antiretrovirals. It is critical to monitor the effectiveness of the multiple drugs prescribed to HIV-1 patients because resistance to these drugs can develop quickly due to virus mutations.

Siemens Healthcare's (Deerfield, IL, USA) new Apple (Cupertino, CA, USA) iMac OSX operating system to support the company's Trugene HIV-1 genotyping kit and the OpenGene DNA sequencing system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA).

Siemens Healthcare provides products across the entire continuum of care--from prevention and early detection, to diagnosis, therapy, and care. The company is a medical solutions provider with core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology, and system integration. Siemens Healthcare is the first integrated healthcare company, bringing together imaging and lab diagnostics, therapy, and healthcare information technology solutions, supplemented by consulting and support services.

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U.S. Food and Drug Administration
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