America & #039;s Blood Supply Can Now Be Screened for Zika

America’s blood supply is better protected from the Zika virus, now that FDA has approved the first test designed to detect the virus in blood donations. Learn about the IVD market at BIOMEDevice San Jose, Dec. 6-7, 2017.  The cobas Zika test from Roche has already been used by several U.S. blood collection establishments under an investigational new drug application (IND). The test can also screen for the virus RNA in specimens collected from living organ donors. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. Marks said the approval is the result of Roche working rapidly and collaboratively with FDA and the blood collection industry to respond to the Zika outbreak, which became a public health crisis last year. In an August 2016 guidance document, the agency recommended that all states and U.S. territories screen individual units of whole blood and blood components with an investigational blood screening test available under an IND application until there was a commercially approved test on the market. The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99%. The Zika virus is transmitted primarily by mosquitos (Aedes aegypti), but it can also be spread through blood tr...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news