Providing testing solutions for international health emergencies
Although the Zika virus is an international health issue which has garnered much attention from the public health community, there is still a lot to be learnt about the transmission of the virus. Experts have confirmed that the virus is a blood-borne pathogen primarily transmitted when an infected mosquito feeds on a human.1
It has also become clear that the virus can be transmitted from person to person in various ways including via bodily fluids and blood donations.2
Keeping the virus out of the blood supply as well as the timely screening of patients have become a major priority in affected areas of the world.
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 concern5. To help prevent the Zika virus from contaminating the blood supply, the FDA issued guidelines addressing blood donations from people experiencing Zika virus infection symptoms or who have travelled to Zika virus affected zones or who have had sexual contact with people fitting into these categories...3
Helping to screen patients exhibiting Zika symptoms
After the FDA’s approval of a Roche assay to be used for the screening of blood samples under an Investigational New Drug (IND) application protocol, we have now made an important contribution in helping to test patients exhibiting Zika symptoms that meet CDC (Centers of Disease Control) criteria including fever, rash, joint pain and red eyes. The molecular diagnostic test enables healthcare professionals to quickly detect the virus. The FDA issues such Emergency Use Authorization during public health emergencies to quickly deploy medical products that are pending clearance or approval for as long as they are needed.
As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging emergencies.
Learn how Roche is helping to ease the supply of blood from one of the researchers, Marintha Heil, Director in Roche Molecular Diagnostics Infectious Diseases Research Group.
Interview with Marintha Heil, a researcher behind the Roche assay for blood screening, approved by the FDA under an IND application protocol.
Why is the Zika virus causing such great public health concern?
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.4
Over the past year, 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.5 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?
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 this 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 IND 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 approved 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.
1. Centers for Disease Control and Prevention (CDC), Zika Virus, Transmission & Risks. Last accessed April 2016 atwww.cdc.gov/zika/transmission/
3. US Food and Drug Administration, FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States. February 16, 2016. Last accessed April 2016 atwww.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm486359.htm
4. CDC, Zika Virus, Symptoms, Diagnosis, & Treatment. Last accessed April 2016 at www.cdc.gov/zika/symptoms/
5. WHO, Statement on the first meeting of the International Health Regulations Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations, 1 February 2016. Last accessed April 2016 atwww.who.int/mediacentre/news/statements/2016/1st-emergency-committee-zika/en/