Screening tests protect blood supplies from contamination by the Zika virus, a mosquito-borne virus linked to birth defects in newborns and neurological problems in adults.

Learn how we are helping to ease the supply of blood from one of the researchers, Marintha Heil, Director in Roche Molecular Diagnostics Infectious Diseases Research Group. Marintha, why is the Zika virus causing such great public health concern?

Marintha: For many, a Zika infection is harmless. Most people do not develop any symptoms after being infected. For those who do develop symptoms, they are usually mild — a rash, headaches, pain in the joints and bones and fever.1

Over the past years, public health officials believe there is growing evidence to suggest that a Zika infection may be linked to birth defects in newborns and neurological conditions in adults. At the moment, epidemiological data is scarce, and if there is an association of infection with birth malformations and neurological syndromes, it is not known what the level of risk is for pregnant women. Concern among public health bodies is high since there are currently no effective interventions to control the mosquitoes that are the primary source for infection.

On 1 February 2016, the WHO announced that a recent cluster of microcephaly cases and other neurological disorders reported in the Americas region constituted a Public Health Emergency of International concern.2 This comes after the International Health Regulation Emergency Committee agreed that a causal link between this cluster and Zika virus disease is strongly suspected.

Why is the safety of blood banks a particular concern?

Marintha Heil, Director in Roche Molecular Diagnostics Infectious Diseases Group.

As of 1 February, 2016, there have not been any confirmed blood transfusion-transmission cases in the United States. There have been two possible transfusion-transmission cases in Latin America. Still, Zika virus infected individuals are often asymptomatic and therefore could unknowingly donate blood while infected. Infections in humans may last up to 14 days. The US FDA has assessed the risk of Zika virus transmission by blood transfusion as likely and has issued Recommendations for Donor Screening, Deferral and Product Management to Reduce the Risk of Transfusion-Transmission of Zika virus.3

How is Roche responding to this ongoing health emergency?

We responded quite quickly. At the beginning of last year, a Roche Molecular Diagnostics research team started designing a blood screening test. Several candidate detection sets and controls were synthesised and tested; a prototype assay and an alternative candidate design were identified. The development and manufacturing of the assay was also concluded very quickly. The FDA Investigational New Drug approval was received on 30 March 2016, which enabled a clinical trial to start on 1 April 2016. We are currently researching additional tests to detect the virus.

How is this investigational assay currently being used?

It is currently being tested and used under an IND approval by the FDA in several blood centres in the southern United States.

Are there plans to make this assay available in other affected zones of the world?

The assay will be available where regulatory agencies allow the test to be utilised under an IND or for emergency use. We continue to work with regulators around the world to determine the path forward to implement the Zika test for blood screening.

Thank you for elaborating about Zika, Marintha!

Tags: Science, Innovation, Diagnostics, Infectious diseases