FDA has granted approval to Roche, Basel, Switzerland, to initiate collection and testing of blood samples for screening with the Cobas Zika assay under an investigational new drug (IND) study protocol. For use with the company’s Cobas 6800 and 8800 systems, the qualitative in vitro nucleic acid screening test offers direct detection of Zika virus RNA in plasma specimens from individual human blood donors.
The Cobas systems consist of a sample supply module, a transfer module, a processing module, and an analytic module. The test makes use of the systems’ fully automated sample preparation, involving nucleic acid extraction and purification, followed by polymerase chain reaction amplification, and detection. Cobas 6800 and 8800 software performs automated data management, assigning results for all tests as nonreactive, reactive, or invalid.
Roland Diggelmann, Roche Diagnostics.
“The Cobas Zika test has been specifically designed utilizing the generic Cobas Omni utility channel on the Cobas 6800 and 8800 systems,” says Roland Diggelmann, chief operating officer at Roche Diagnostics. “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.”
Roche seeks to provide testing solutions for the world’s most challenging healthcare emergencies, says Diggelmann. “With the collaboration of FDA on this IND, we are able to further expand our commitment to help keep the blood supply safe,” he says.
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 reinstatement of blood services in Puerto Rico and reduce the territory’s reliance on 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 the area first affected by any spread of the virus on the mainland.
FDA’s IND status authorizes use of the Cobas test by US blood screening laboratories under a specific protocol, but does not constitute clearance or approval of the test. All laboratories using the test will need to be enrolled and contracted into the clinical trial, as specified and agreed with FDA’s Center for Biologics Evaluation and Research.
For more information, visit Roche.
