Abstract
About 80% of the world’s population lives in areas affected by diseases transmitted by insects (Global Vector Control Response, WHO, 2017). The World Health Organization (WHO) is currently conducting surveillance on virus spread, developing and distributing better diagnostic tests, and providing guidance to states and localities in the areas at risk on strengthening mosquito growth control. Mosquito control programs, scientific expertise, and financial resources vary significantly throughout the world, ranging from absent or limited capacity in some jurisdictions to advanced integrated mosquito management programs in others. In particular, the transmission of arboviral diseases through Dengue [DENV], Chikungunya [CHIKV], and Zika [ZIKV] viruses pose new challenges for public health. These three pathogens can produce similar clinical symptoms, mainly during the acute phase, hindering clinical diagnosis and creating problems for appropriate case management, sometimes triggering fatal events. In this perspective, Alifax R&D will address patients’ needs by applying its innovative rapid real-time qualitative polymerase chain reaction (RT-qPCR) device to create a robust diagnostic point-of-care (PoC) for genotyping of ZIKV, DENV, and CHIKV. In the ZIDECHIP project (Funded by POR FESR, 1489/2017), the leading company, Alifax R&D, will combine its technology with the expertise on the field of tropical diseases of International Center for Genetic Engineering and Biotechnology (ICGEB), to develop an in vitro diagnostic device that will be validated in collaboration with Laboratori Riuniti of Trieste.
Innovative features & competitive advantage
The ZIDECHIP project aims to develop a point-of-care (PoC) device for fast diagnosis of tropical pathogens (ZIKV, DENV, and CHIKV), which will have a significant impact on the world health system. To this end, Alifax will apply its innovative technology for rapid detection of nucleic acids partnering with ICGEB, a research institute with expertise in tropical diseases, and Laboratori Riuniti fortests on clinical samples. The technology is based on real-time qualitative polymerase chain reaction (qPCR), a molecular biology technique already established in the clinical field for the analysis of genetic material. The commercial kits for detection of tropical pathogens available on the market are all based on current qPCR instrumentation. These instruments are still very expensive, cumbersome, and complex, requiring qualified staff. Alifax’s portable qPCR, instead, can easily perform rapid qualitative analysis of nucleic acids through an integrated approach of high-end nanotechnologies. The integrated user-friendly software platform will translate experimental raw data into a significant clinical report that will be immediately available to clinicians allowing for prompt personalized treatment. The competitiveness of the ZIDECHIP PoC device will rely on its key features, such as rapid time-to-result, higher automation, highly reliable data, lower cost, user-friendly interface, and secure data sharing. The outstanding cost-effectiveness of the ZIDECHIP device, together with its high reliability and accuracy, will extend the molecular diagnostic market of arboviruses from the current large centralized lab to near-patient sites, such as urgent care clinics.
Market sector & future commercial prospectives
Despite the efforts of WHO, arboviruses continue to spread geographically to areas where competent vectors are present, leading to the persistence of global risk assessment. The size of the ZIKV, DENV, and CHIKV test market was evaluated to be around USD 500 million in 2017, progressing at a Compounded Average Growth Rate (CAGR) of 6–8% during the forecast period (by 2023–2027). Recent outbreaks and the correlation between ZIKV infection and microcephaly in newborns, are fueling market growth, with an increased request for effective diagnostic point-of-care. In this regard, the compact, easy-to-use, rapid, and low-cost ZIDECHIP diagnostic tool has high potential to improve routine medical practice and impact all levels of healthcare. Device features will let decentralization from highly specialized clinical laboratories to near-patient sites, such as urgent care clinics, especially in the developing world, having a substantial impact on preventive and welfare policies. Integration of this PoC device with screening and prevention programs will lead to an increase in patient longevity and improved quality of life; it will also reduce the economic burden on the public health system. The market potential for this diagnostic tool is broad, covering global small-to-large sized diagnostic laboratories. Moreover, considering the consolidated worldwide sales network of Alifax Srl, the market will be approached in a highly competitive way. Consequently, we are expecting fast growth and early turnover, allowing for new employment, partnering and investment opportunities.