Development and commercialization of a simple, rapid and low cost nucleic acid test for Hepatitis C Virus (HCV) diagnosis

Abstract

Hepatitis B and hepatitis C virus (HBV and HCV, respectively) infections are major causes of acute and chronic liver diseases that cause an estimated 1.4 million deaths globally each year. Antiviral treatments can prevent the majority of deaths related to these diseases. However, access to testing and treatment is limited, especially in lower and medium income countries (LMIC) due the high costs of medicines and diagnosis. The WHO's Global Health Sector Strategy (GHSS) recently called for the elimination of viral hepatitis as a public health threat by 2030 and expects to reduce new infections by then by 90% and mortality by 65%. Vaccination, testing, monitoring and treatment are the steps required to achieve this goal. DASL-RAPID, a simple, rapid and low-cost detection and quantification method for HBV and HCV infections using DBS, would make it possible to achieve this goal in LMIC.DASL-RAPID is a novel, proprietary DNA/RNA isothermal amplification technology that can detect trace amounts of nucleic acid from pathogenic microorganisms. To date, DASL-RAPID has been successfully employed in several proof of concept assays to successfully detect Zika virus in human urine, HIV-1 in human blood and Listeria and Salmonella in certain food products. These efforts have validated the use of DASL-RAPID as a low cost and easy to use diagnostic test method. During the past 10-15 years, tests that detect RNA/DNA of pathogenic organism have been shown to deliver higher performance, accuracy and fewer false positives than traditional immunoassays and cell-based assays. Moreover, the nucleic acid tests (NAT) are typically cheaper to run and have a faster turnaround time. DGLab in Sao Paulo, Brazil specializes in the development of diagnostic assays using digital PCR and has recently developed a test to detect HBV in DBS. DGLab is affiliated with Adolfo Lutz, a national laboratory of public health in Sao Paulo. Now, DGLab and Custom Biologics have established a mutual interest in co-developing and commercializing a proprietary DASL assay to detect and quantify HCV in DBS, by implementing it by partnering with Adolfo Lutz in order to diagnose and monitor HCV infection throughout Brazil. The goal of this project is to development a rapid, easy to use and cost-effective nucleic acid test for HCV in DBS. This test would be ideal for use in LMIC with poor laboratory facilities and limited infrastructure. A DASL HCV assay would be easy to perform and would not require highly skilled technicians or expensive laboratory equipment. (AU)