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.