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

Regulatory NewsRegulatory News
| 30 March 2016 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus.

In a statement, the agency said it is allowing the test, developed by Roche Diagnostics, to be used to screen blood in areas, such as Puerto Rico, where the virus is actively transmitted.

When reached for comment, Roche spokesman Bob Purcell told Focus that screening with the test will begin "in the next few days."

Purcell also credited FDA for helping speed the test's availability, saying, "FDA was highly collaborative and responsive during the review of the [investigational new drug application] IND. Specifically, FDA's Center for Biologics Evaluation and Research [CBER] was very fast and very clear with feedback on technical and scientific requirements for analytical verification and validation with clinical samples."

Blood Donor Screening

The authorization of the diagnostic comes after FDA issued guidance in February saying that blood and blood components should not be sourced from areas with active Zika transmission unless a FDA-licensed blood donor screening test is available. However, the guidance also states that an "investigational donor screening test under an investigational new drug (IND) … may be permitted in situations where approved technologies are unavailable."

FDa's blood donor guidance also established a four-week deferral period for blood donors diagnosed with Zika, or who meet certain risk factors, such as travel to a Zika-affected region or have had sex with someone who has been diagnosed with the virus.

Notably, FDA has not authorized Roche's test for patient diagnostic use, and has only cleared the test for blood donor screening under the IND. According to Purcell, "any new sites wishing to carry out Zika testing for the screening of blood donations would have to be approved by FDA before being able to commence [testing].

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

Following FDA's recommendation, Puerto Rico halted local blood collection, and the Department of Health and Human Services (HHS) began supplying the territory with blood supplies in early March.

However, FDA says that blood banks in Puerto Rico will be able to begin collecting donations once the investigational test is made available.

Additionally, Roche says its next step will be to prepare to deploy the test in areas of the southern US that are likely to see local transmission of the virus in the near future.

Investigational Screening Test

"The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation's blood supply, especially for those US territories already experiencing active transmission," said CBER Director Peter Marks.

The test works with Roche's Cobas 6800/8800 Systems to detect Zika virus RNA in plasma sourced from blood donors.

"The cobas Zika test has been specifically designed utilising the generic cobas omni Utility Channel on the cobas 6800/8800 Systems. These fully-automated high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion," Roland Diggelmann, COO of Roche Diagnostics, said.

FDA, Roche


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