Roche on March 31, 2016 announced that the US Food and Drug Administration (FDA) has provided approval to initiate collection and testing of blood samples for screening with its 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.
Roland Diggelmann, COO, Roche Diagnostics, said, “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 US. 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 US, which will most likely be impacted by any spread in the virus.
Roland Diggelmann, COO, Roche Diagnostics, said, “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 US. 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 US, which will most likely be impacted by any spread in the virus.
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app
SAVE 25%