HIV-1 Genotyping Kit to Identify Viral Resistance

They have both been recently cleared by the U.S. Food and Drug Administration (FDA). The viral resistance information they provide can help doctors prescribe more appropriate drug regimens and improve patient care.

The sequencing system, called OpenGene, employs a single-step sequencing method intended to reduce the time and cost involved in identifying clinically relevant information. Tests performed using the genotyping kit, called Trugene, have shown that the system can rapidly and consistently deliver accurate results in a clinical setting, according to the developer, Visible Genetics Inc. (Toronto, Canada). The company manufactures and markets automated DNA sequencing systems and kits for the analysis of genes linked to disease.

"Trugene is the first product of its kind that has been cleared by the FDA to offer simplified genetic testing technology allowing physicians to personalize therapy for each individual HIV patient,” said Richard T. Daly, president and CEO of Visible Genetics. "The immediate applications are in HIV but additional applications in the future are hepatitis C, hepatitis B, and oncology.”



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