The approval follows screening recommendations made by the Blood Products Advisory Committee (BPAC) of the FDA in December, and facilitates a more simplified testing process for blood screening laboratories that have been using the cobas systems in the US.
Roche first deployed the Zika test in April 2016 under the FDA’s Investigative New Drug (IND) protocol to test its screening efficacy 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 specifity of 99%. Its proven capabilities in this initial observation led to the reinstatement of blood services on the island.
Zika, a virus infection the results in newborn defects and neurological complications in both children and adults, is transmitted through sexual intercourse, birth, and susceptibly through donor blood transfusions.
The cobas Zika test received approval from the FDA in October 2017, allowing its use in donor screening through the continental US 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,” Marks said.