FDA Approves New Claim for Zika Virus Test Allowing for Screening of Pooled Blood or Plasma Donations


The FDA has approved an additional claim for Roche’s cobas Zika virus test, allowing for the screening of several individual blood or plasma donations that have been pooled together.

An additional claim for Roche’s cobas Zika test for use on the cobas 6800/8800 Systems has been approved by the US Food and Drug Administration (FDA) this week, allowing for the screening of several individual blood or plasma donations that have been pooled together.

The approval follows screening recommendations made by the Blood Products Advisory Committee (BPAC) of the FDA at the beginning of December and facilitates a more simplified testing process for blood screening laboratories that have been using the cobas software in the United States.

Roche first deployed the Zika test in April 2016 under the FDA’s Investigative New Drug (IND) protocol to test its screening efficacy on blood donations collected in Puerto Rico — a location designated for testing due to concerns over high rates of local Zika infection in blood supplies. In data collected from the uses, as well as additional manufacturer studies, the test returned a clinical specificity of 99%; its proven capabilities in this initial observation led to the reinstatement of blood services on the island..

The FDA approved the cobas Zika test in October 2017, allowing its use in donor screening through the continental United States and Puerto Rico. The fully-automated systems are designed for high-volume automated sample pooling through sample preparation, polymerase chain reaction amplification, and detection. Tests results return either non-reactive, reactive, or invalid — ensuring possibly-infected blood units are not used for transfusions.

At the time of the test’s approval, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the approval — the first of its kind for a detection test that screens national blood supplies — was collaborative effort between manufacturers and the agency to improve blood collection industry’s response to public health crises.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply,” Dr. Marks said. “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 United States and its territories."

A previous version of this article has appeared on MDMagazine.com.

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