FDA OKs Roche’s cobas Zika Test to Screen Multiple Pooled Blood or Plasma Donations

Roche announced today FDA approval of an additional claim for the cobas Zika test for use on the cobas 6800/8800 Systems.  The newly approved claim allows for the streamlined screening of multiple individual blood or plasma donations that have been pooled together.
 
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.
 
“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,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “Roche is pleased to offer additional screening options that support BPAC recommendations for the US market.”
 
Roche deployed the cobas Zika test in April of 2016 under the FDA’s IND Protocol to screen blood donations collected in Puerto Rico. This initial testing protocol enabled the reinstatement of the blood services in Puerto Rico after concerns over the high rates of infection locally posed a significant threat to the blood supply. The cobas Zika test received commercial approval from the FDA in October of 2017, enabling routine use of the cobas Zika test to support individual donor screening efforts throughout Puerto Rico the continental United States.