25 June 2012

Procleix Panther^® System and Ultrio Elite^® Assay Receive CE Mark

Novartis Diagnostics announced CE Mark certification of the Procleix^® Ultrio Elite^® assay, a new highly sensitive screening test for blood banks working to protect transfusion patients and blood supplies from infection with HIV and Hepatitis. The test, like others in the Procleix Ultrio family, reduces the risk of missed HIV infections in donated blood by detecting two separate regions of the HIV Type 1 genome - a virus with high rates of mutation that is responsible for 99.6% of HIV infections worldwide. The assay also detects HIV Type 2, a very low prevalence type of HIV that is a public health concern in some countries.

The test will run on the new CE marked Procleix Panther^® System, a compact and easy-to-use instrument that combines full automation of NAT and touch-screen operation with the unique ability to handle continuous-load or batch processing. The system allows labs testing donations individually or in pools to speed release of blood to healthcare providers with fast daily start-up, access to results as they become available, reporting of results directly to the laboratory information system (LIS), and automated scheduled maintenance.