FDA Approves CobasZika Test for Zika Virus in Screening Blood Donations

FDA recently granted approval of a biological license application from Roche Molecular diagnostics, Pleasanton, Calif, for the company’s CobasZika test is a qualitative nucleic acid test, in individual plasma specimens obtained from volunteer donors of whole blood and blood parts, and from living organ donors for the detection of Zikavirus RNA. To identify Zika virus in blood donations, the test is intended for use by blood collection foundations, not for the individual diagnosis of Zikavirus infection.

Peter Marks, MD, PhD, chief of FDA’s Center for Biologics Evaluation and Research said, “Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply. Screening blood donations for the Zikavirus is critical to preventing infected donations from entering the US blood supply. The present approval is the result of a commitment by the manufacturer to work quickly and cooperatively with FDA and the blood collection industry to react to a public health crisis and ensure the safety of blood in the United States and its regions.”

FDA issued a final draft in August 2016, recommending that all states and domains screen individual units of whole blood and blood components with a blood screening test available under an investigational new drug (IND) application or, when available, with an authorized (approved) test.

TheCobasZika test under IND approval, several blood collection establishments already utilized so as to take the recommendations in FDA’s 2016 guidance document. The information gathered from that testing, and from additional studies performed by the manufacturer which shows that the CobasZika test is an effective test to screen blood donors for Zikavirus infection. From blood donations at five external laboratory sites, the test’s clinical specificity was assessed by testing individual samples, resulting in about the clinical specificity of over 99%.

Primarily by Aedesaegypti mosquitos, the Zika virus is transmitted, but it can also be spread through blood transfusion and sexual contact. Although the vast majorities infected with Zika virus don’t develop symptoms when symptoms do occur they may include arthralgia (joint pain), conjunctivitis (red, irritated eyes), fever, or maculopapular rash (red area with small bumps). Moreover, Zika virus infection can cause a serious neurological disease in adults, and infection during pregnancy can cause serious birth defects.

The CobasZika test is intended for use on the completely automated Cobas 6800 and Cobas 8800 systems. The CobasZika test, Cobas 6800, and Cobas 8800 systems are manufactured by Roche Molecular Systems Inc.

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