Roche’s 99% accurate Zika test receives FDA approval
pharmafile | October 9, 2017 | News story | Sales and Marketing | Roche, Zika, biotech, drugs, pharma, pharmaceutical
Roche has revealed that the FDA has given approval to its cobas Zika test to determine whether a blood sample is infected with the virus. The test is to be used to screen blood donations to ensure that the virus is not transmitted through the blood supply network.
Roche’s cobas 6800/8800 systems had already been in use from 2016 under the Investigational New Drug Application protocol when infection rates in Puerto Rico began to rise. The device was used to screen more than 4 million blood donations from the US and Puerto Rico.
The Zika test is a qualitative in vitro nucleic acid screening test, able to Zika virus RNA in plasma specimens.
The use of the screening device successfully helped to identify more than 450 potentially infectious donations into the blood supply.
In further measures, the clinical specificity of the systems was found to be higher than 99%. The approval means that the device can now be used nationwide to determine the safety and security of blood supply network, through hospitals and clinics.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the US and its territories.”
Fears over the spread of the virus have died down since the peak last year, but efforts are still underway, such as this one, to make sure that there is a significantly reduced threat.
Most people are able to fight off the virus without any obvious symptoms, however it was found to cause, in some cases, neurological complications in children and adults.
There has recently been promising results from a vaccine completing a Phase 1 trial, with the vaccine, GLS-5700, being shown to promote Zika virus-specific antibodies in 100% of subjects.
Ben Hargreaves
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