March 31, 2016
Roche has started testing for Zika virus at U.S. Blood Centers under FDA Investigational New Drug Application protocol
Roche has declared that it has got approval from the U.S. Food and Drug Administration (FDA), under an Investigational New Drug Application (IND) protocol, for initiating collection and testing of blood samples for screening with the cobas® Zika assay. This cobas® Zika test, used with the cobas® 6800/8800 Systems, is a qualitative in vitro nucleic acid screening test to detect Zika virus RNA directly in plasma specimens from individual human blood donors.
Roland Diggelmann, COO of Roche Diagnostics, said: “The cobas® Zika test has been specifically designed utilizing 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. 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.”
At first, the cobas® Zika test will be conducted to screen blood donations collected in Puerto Rico locally. It is anticipated that this testing will permit the reinstatement of the blood services in Puerto Rico and decrease the dependence of blood importation from other areas in America. In the second stage of the cobas® Zika test, screening of the blood collected by blood services in the southern United States will be done, which will almost certainly be impacted by any spread of the virus. Roche will continue working with regulators from other parts of the world to identify the path forward for implementing the cobas® Zika test for blood screening.
During this cobas® Zika test, a fully automated sample preparation (nucleic acid extraction and purification) is followed by PCR amplification and detection. The cobas® 6800/8800 Systems consists of four different modules: sample supply module, the transfer module, the processing module and the analytic module. In addition to these, the cobas® 6800/8800 software performs the automated data management assigning all tests as reactive, non-reactive, or invalid.
The largest biotech company of the world is Roche. In order to make a sustainable contribution to society, Roche continues to search for better ways to prevent, diagnose and treat diseases. This initiative to test for Zica virus will certainly make a tremendous contribution in the global healthcare system.