According to a recent press release from Roche, the FDA has approved an additional claim for its cobas Zika test for use on the cobas® 6800/8800 Systems. The newly approved claim allows for streamlined screening of pooled blood or plasma donations.
First identified in Uganda in 1947, the Zika virus is transmitted by Aedes mosquitoes. Zika virus infection is associated with neurological complications in adults, and brain defects in fetuses and newborns.
Deployed in April 2016, the cobas Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors. The cobas Zika test provides solutions for blood services to detect Zika virus and ensure that potentially infected blood units are not made available for transfusion. Plasma from all donors should be screened as individual samples.
The cobas® Zika for use on the cobas® 6800/8800 Systems received commercial approval from the FDA in October 2017, enabling routine use of the test to support individual donor screening efforts throughout Puerto Rico the continental United States.
The new claim follows the screening recommendations made at the December 1, 2017 meeting of the Blood Products Advisory Committee (BPAC), an appointed group of key medical & scientific advisors to the FDA. In addition to supporting the most recent BPAC recommendations, the extended claims for cobas® Zika facilitate a simplified testing workflow for blood screening laboratories utilizing the cobas® 6800/8800 Systems with the cobas® Synergy software solution in the United States.
Uwe Oberlaender, Head of Roche Molecular Diagnostics, said, "More than 6 million blood donations from the United States and Puerto Rico have been screened with the cobas® Zika test since its initial release under the Investigational New Drug Application (IND) protocol in 2016 and subsequent commercial approval in 2017. Roche is pleased to offer additional screening options that support BPAC recommendations for the US market."