The British Standards Institute (BSI) has awarded ISO 13485: 2003 certification to Zyomyx's quality management system.
Zyomyx is involved in developing and commercializing proprietary diagnostic platforms including quantitative disposable CD4 diagnostics, which will support expanded access to HIV treatment.
Zyomyx said achieving ISO 13485: 2003 certification is a critical first step toward both WHO Pre-Qualification and a CE mark.
Zyomyx CEO Peter Wagner said the certification enables the company to move closer to the expected launch of its new CD4 point-of-care test in 2013.
"This strengthens the confidence our customers and partners have in Zyomyx and provides a solid foundation as we adapt our novel platform technology for other clinical applications as a leader in the commercialization of highly accessible cell count diagnostics," Wagner added.