Research & Development
Roche passes US FDA's approval for additional claim for cobas Zika test on cobas 6800/8800 Systems for screening of multiple individual blood
14 May 2018 -

Pharmaceutical company Roche (SIX:RO)(OTCQX:RHHBY) revealed on Friday the receipt of approval from the US FDA for an additional claim for the cobas Zika test for use on the cobas 6800/8800 Systems for streamlined screening of multiple individual blood or plasma donations that have been pooled together.

This new claim is based on the recommendations from the screening recommendations made at the December 2017 meeting of the Blood Products Advisory Committee (BPAC), an appointed group of key medical & scientific advisors to the US FDA.

In the US, the extended claims for cobas Zika facilitate a simplified testing workflow for blood screening laboratories utilising the company's cobas 6800/8800 Systems with the cobas Synergy software solution.

Under the US FDA's IND Protocol, the cobas Zika test was deployed to screen blood donations collected in Puerto Rico. This initial testing protocol enabled the reinstatement of the blood services in Puerto Rico after concerns over the high rates of infection locally posed a significant threat to the blood supply. The cobas Zika test support individual donor screening efforts throughout Puerto Rico the continental US.

According to the company, the cobas Zika test for use with the cobas 6800/8800 Systems and cobas Synergy software, 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. The fully-automated, high-volume systems perform automated sample pooling, automated sample preparation as well as PCR amplification and detection. The system provides solutions for blood services to detect Zika virus and ensure that potentially infected blood units are not made available for transfusion.

The Zika virus belongs to the Flaviviridae family of viruses, which includes dengue, yellow fever, Japanese encephalitis and West Nile viruses. Zika is primarily spread by the bite of infected mosquitoes; however, transmission through sexual intercourse and from pregnant mothers to fetuses has also been documented.

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