FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika

The Food and Drug Administration (FDA) said Wednesday it will allow the use of an experimental blood test to screen donated blood for Zika.

In a statement, the agency said it allows the test developed by Roche Diagnostics for use in the blood of the screen in areas such as Puerto Rico, where the virus is transmitted actively.

When contacted for comment, a spokesman for Roche said Bob Purcell developed the screening test will begin with the "in the coming days."

Purcell also accredited by the FDA to help accelerate the availability of the test, saying. "The FDA was highly collaborative and responsive during the review of the [new application for experimental drug] IND Specifically, the FDA Center for Biologics evaluation and Research [CBER] was very quick and very clear with comments on the technical requirements and analytical scientists for verification and validation with clinical samples. "

The selection of blood donors

The authorization of diagnosis occurs after the FDA issued guidelines in February saying that blood and its components shall not come from areas Zika active transmission unless a screening test for blood donors FDA approved is available. However, the administration also notes that a "test of experimental donor under an investigational new drug (IND) ... may be permitted in situations approved technologies are not available."

blood donor FDA guidance also established a four-week postponement of blood donors diagnosed with Zika, or who meet certain risk factors, such as traveling to an affected or Zika had sex with someone area it has been diagnosed with the virus.

In particular, the FDA has not approved the Roche test for the diagnosis of the patient, and has licensed the test for screening blood donors under the IND. According to Purcell, "all new sites wishing to Zika tests for screening blood donations must be approved by the FDA before they can start [testing].

So far, the FDA has issued emergency use authorizations for two tests developed by the Centers for Disease Control and Prevention to diagnose patients Zika

Following the recommendations of the FDA, Puerto Rico stopped the local blood collection, and the Department of Health and Human Services (HHS) has started to provide the territory with the blood supply in early March.

However, the FDA said that blood banks in Puerto Rico will start collecting donations once the experimental test is available.

Roche also said its next step will be to prepare the deployment of proof in the southern areas of the United States is likely to see local transmission in the near future.

Research evidence

"The availability of an experimental test to screen donated blood for the virus Zika is, especially for those who already know the US territories active role in maintaining the safety of the blood supply of the nation step transmission "director Peter brands CBER said.

Works with Roche Cobas 6800/8800 test systems to detect Zika RNA plasma of blood donors.

"The cobas Zika has been specially designed using the generic Utility omni channel Cobas in the cobas 6800/8800 Systems. These systems provide high volume fully automated solutions for blood services for the virus and ensure that potentially infected blood units not are available for transfusion, "Roland Diggelmann, COO of Roche Diagnostics, said.