FDA expands use of Zika screening test
The US Food and Drug Administration (FDA) approved an additional claim for the cobas Zika test, manufactured by Roche Molecular Diagnostics, the company announced today in a news release. The approval allows the test to be used to screen pooled blood and plasma donations for the Zika virus.
According to Roche, the new application will streamline the screening process of multiple individual blood or plasma donations.
"More than 6 million blood donations from the United States and Puerto Rico have been screened with the cobas Zika test since its initial release under the Investigational New Drug Application (IND) protocol in 2016 and subsequent commercial approval in 2017," said Uwe Oberlaender, PhD, head of Roche Molecular Diagnostics.
The cobas test was first used in April 2016 by the FDA to screen blood donations from Puerto Rico. In October of 2017, the FDA approved cobas for commercial use.
May 14 Roche press release
Experimental universal flu vaccine receives Innovate UK award
Innovate UK, the United Kingdom's innovation agency, granted more than $1 million to Emergex, a biotechnology company headquartered in Oxford, for work on a universal flu vaccine.
According to Emergex, the £979,318 ($1.3 million) grant will cover 70% of costs needed for its universal flu vaccine program for the next 2 years.
"It will be used to complete preclinical toxicology and validation studies," the company said in a press release. "This will result in clinical batches of the vaccine which are ready for Phase I clinical testing in the first half of 2020."
The universal flu vaccine will target components that all strains of the flu have in common. Emergex's product is based on reverse engineering and is made from 100% synthetic peptide fragments.
In addition to a universal flu vaccine, Emergex is working on universal vaccines to target flaviviruses (including Zika) and filoviruses (Ebola and Marburg).
May 14 Emergex press release