Abbott receives CE Mark for new testosterone assay

Abbott has been granted European CE Mark accreditation for a new testosterone assay that aims to offer improved sensitivity and clinical utility compared to existing options.

The Architect 2nd Generation Testosterone Assay works using a simple blood test and can accurately measure a wide range of testosterone levels across various patient populations and clinical settings, including male and female subjects or those with low levels of the hormone.

It addresses an unmet clinical need, with a consensus statement from the Endocrine Society in 2010 noting that more sensitive testosterone assays are necessary to improve the diagnosis, treatment and prevention of disease.

The new assay runs on Abbott's fully-automated Architect family of analysers and is now available in several European nations.

Brian Blaser, executive vice-president for diagnostics products at Abbott, said: "Healthcare providers can now confidently measure testosterone levels and use this information to improve treatment decisions for their patients."

Last week, the company also introduced its new Xience Xpedition everolimus-eluting coronary stent system in Europe after being granted CE Mark approval.