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FDA approves Roche’s new claim for Zika blood test
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Roche recently announced that its additional claim for the cobas Zika test has been approved by the FDA. The new claim allows for more streamlined screening of multiple individual blood or plasma donations, potentially reducing costs associated with increased blood testing.
The cobas Zika test was first launched under the FDA’s investigational new drug protocol in April 2016 to screen blood collected in Puerto Rico. The FDA then commercially approved the test, which is used on the cobas 6800/8800 Systems in the U.S. market, in October 2017.
Testing can be costly, and although the benefits are unclear, all U.S. blood donations must continue to be tested for the Zika virus, according to the FDA. Roche’s new claim for the cobas Zika test follows the FDA’s Blood Products Advisory Committee’s new guidelines, released in December 2017, which facilitate cost-effective and timely delivery of blood products, according to the company. The assay can now be used in pooled testing — a more efficient method than individual screening — and the company said it is approved to screen pools of up to six samples for Zika virus RNA.
“The pooled testing workflow in the new claim may help ensure that fully screened, low-risk transfusion products are routinely available to support patient safety,” Lisa Lee Pate, MD, JD, director of clinical science for blood screening at Roche, told Infectious Disease News. – by Marley Ghizzone
Disclosure: Pate is employed by Roche.