Zika Virus (ZIKV) Diagnostics
There is currently no commercially available test for ZIKV diagnosis. UNICEF is working with partners and industry to transform today’s under-supplied ZIKV diagnostics market.
The Challenge
ZIKV and its suspected link to birth defects was declared by the World Health Organization (WHO) as a Public Health Emergency of International Concern in February 2016. ZIKV is transmitted through the bite of an infected Aedes mosquito, the same mosquito that transmits dengue and chikungunya. The geographical distribution of ZIKV has steadily widened since the virus was newly detected in the Western Pacific in 2007. As of December 2016, 75 countries and territories have reported evidence of mosquito-borne ZIKV transmission since 2007 (69 countries with reports from 2015).
The Project
The ultimate purpose of the project is to ensure that effective and affordable tests for ZIKV that can be used at community level become commercially available in the fastest possible timeframe. In addition to diagnosing individual cases, the availability of such diagnostics will help to resolve the scientific uncertainties surrounding ZIKV infection. The project, in collaboration with WHO and PAHO, aims to drive the development of efficient and accurate diagnostics for both active infection and evidence of prior infection with ZIKV. Two Target Product Profiles, one for each diagnostic test, address current ZIKV diagnostic challenges and are intended to meet the needs of different population groups. In particular, because the greatest impact of ZIKV infection appears to occur during pregnancy, there is a need for highly accurate tests, and a diagnostic testing algorithm that can be applied during routine antenatal care or counselling.
UNICEF Supply Division hosted an industry consultation in Copenhagen in May 2016 and convened partners and diagnostics and vaccine manufacturers to encourage the acceleration of R&D and to advance the commercial environment to address gaps in vaccine and ZIKV Diagnostics (for testing at point-of-care) urgently required to fight ZIKV. Furthermore, UNICEF convened the 1st ZIKV Diagnostics webinar in August 2016 as a follow-up on the industry consultation to update industry and partners on current developments, revised demand profiles, including UNICEF’s procurement approach and timelines for the ZIKV diagnostics tender.
UNICEF worked with USAID to develop an Advance Purchase Commitment (APC), which aims to reduce demand uncertainty risks for manufacturers who invest in R&D towards new products.
In February 2017, UNICEF issued its first tender for the Procurement of ZIKV Diagnostics (for testing at point-of-care), including for access to an APC for procurement during the period 2017-2019.
UNICEF convened the 2nd ZIKV Diagnostics webinar in May 2018 to update industry and partners on current developments, revised demand profiles, including UNICEF’s procurement approach and timelines for the 2nd ZIKV diagnostics tender.
UNICEF finalized a service agreement with the London School of Hygiene & Tropical Medicine to conduct the development of necessary reference materials and evaluation of the UNICEF awarded ZIKV diagnostics through access to a network of specimen collection sites that can also function as evaluation sites.
In June 2018, UNICEF issued its second tender for the procurement of ZIKV Diagnostics (for testing at point-of-care), including for access to an APC for procurement during the period 2017-2019. Contract Awards were announced in April 2019.