Roche to initiate Zika testing following FDA IND protocol
March 30, 2016 – BASEL. Roche today announced that the U.S. Food and Drug Administration (FDA) has provided approval to initiate collection and testing of blood samples for screening with the cobas® Zika assay under an Investigational New Drug Application (IND) protocol. The cobas® Zika test for use with the cobas® 6800/8800 Systems, 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 has been specifically designed utilising the generic cobas omni Utility Channel on the cobas® 6800/8800 Systems. These fully-automated high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion” said Roland Diggelmann, COO Roche Diagnostics. “As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies. With the collaboration of the FDA on this IND, we are able to further expand our commitment to help keep the blood supply safe.”
Initially, the cobas® Zika test will be deployed to screen blood donations collected locally in Puerto Rico. It is expected that this testing will enable the reinstatement of the blood services in Puerto Rico and reduce the reliance of blood importation from other areas in the United States. The second stage of deployment for the cobas® Zika test will be to prepare for screening of blood donations collected by blood services in the southern United States, which will most likely be impacted by any spread in the virus.
Roche continues to work with regulators around the world to determine the path forward to implement the cobas Zika test for blood screening.
About the cobas® Zika test
Manufactured by Roche, the cobas® Zika test is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module and the analytic module. Automated data management is performed by the cobas® 6800/8800 software which assigns test results for all tests as non-reactive, reactive, or invalid.
About IND StatusThis test has not been FDA cleared or approved; This test has been authorized by FDA for Use under a specific protocol by US Blood screening laboratories. All Testing Laboratories will need to be enrolled in and contracted into the Clinical trial as specified and agreed with the FDA Center for Biologics Evaluation and Research.