In the last few weeks we have seen the emergence of a new global public health threat, the Zika Virus (ZIKV). Both the World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) are monitoring the spread of the Zika, a mosquito borne arbovirus. The WHO recently declared the diseases linked to the Zika virus as a global public health emergency.
Several Zika cases have been reported in Europe from people who have contracted the virus while travelling. The bigger risk however is when mosquito populations in Europe become infected and start acting as a vector for the disease. The map shows the distribution of Aedes albopictus which can become a carrier of Zika in Europe.
At this stage, a lot of critical questions remain: What are the risks associated with Zika? Is there a potential link between Zika infections in pregnant women and microcephaly results in newborns?
The Role of Diagnostics
Developing adequate diagnostic tools becomes critical especially since Zika infections can display no symptoms or symptoms similar to other viral infections.
In the short term, diagnostic tools will track the spread of the infection. Understanding how the epidemic spreads will be a critical step in controlling it. Accurate diagnostic tools will be needed to understand the relationship between Zika and microcephaly.
Diagnostic tools, in the long term, will be essential in developing treatments and vaccines to combat Zika. If the link between Zika and microcephaly is confirmed, it will be equally critical to manage the potential risks during pregnancy. Detecting active Zika infections and determining the immune status of the mother with regards to Zika will be essential in reducing its impact during pregnancy.
Precautionary measures are now being taken to ensure the safety of the blood donations – travellers who have been to areas where Zika is propagating are being told to refrain from donating blood for 28 days. In the long term, ensuring the safety of the blood supply especially in areas where Zika may become established will require screening blood donations to ensure the safety of the blood supply.
Fortunately, the Zika genome has been sequenced and it comes from the well-known flavivirdae family of viruses. Commercial diagnostic tools which can be widely deployed are being developed. But simply innovating in this area is not enough to ensure that the tests will become available throughout Europe on time.
Challenge of managing epidemics in Europe
Epidemics like Zika are a real challenge for the regulatory system in Europe. On the one hand we are looking at new diagnostic tools which are to be deployed to combat an emerging health threat. But this triggers some of the more stringent regulatory provisions requiring significant time to bring a developed product on the European market.
On the other hand, there is a public health need to distribute and use diagnostic tools when they become available in order to mitigate the potential threat. Epidemics, unfortunately, wait for no law. Emergency approval of such diagnostic tests is one of the essential improvements in the proposed IVD regulation. It ensures that Europe as a whole is able to address emerging public health threats with the best tools that medical technology has to offer.