Research & Development
Roche Receives FDA Approval of Additional Claim for Cobas Zika Test Allowing Screening of Pooled Blood Or Plasma Donations
16 May 2018 - - Basel, Switzerland-based biotech company Roche (SIX: RO, ROG; OTCQX: RHHBY) has received FDA approval of an additional claim for the cobas Zika test for use on the cobas 6800/8800 systems, the company said.
The newly approved claim allows for the streamlined screening of multiple individual blood or plasma donations that have been pooled together.
The new claim follows the screening recommendations made at the December 1, 2017 meeting of the Blood Products Advisory Committee (BPAC), an appointed group of key medical and scientific advisors to the FDA.
In addition to supporting the most recent BPAC recommendations, the extended claims for cobas Zika facilitate a simplified testing workflow for blood screening laboratories utilizing the cobas 6800/8800 Systems with the cobas Synergy software solution in the US.
Manufactured by Roche, 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 test provides solutions for blood services to detect Zika virus and ensure that potentially infected blood units are not made available for transfusion.
Roche combines pharmaceuticals and diagnostics to provide a personalised healthcare strategy that fits the right treatment to each patient in the best way possible. The company continues to search for better ways to prevent, diagnose, and treat disease, to make a sustainable contribution to society, and to improve patient access to medical innovations by working with all relevant stakeholders. The Roche Group is active in over 100 countries and in 2016 employed more than 94,000 people worldwide.


Related Headlines