NEW YORK (360Dx) – The Foundation for Innovative New Diagnostics today announced that it is awarding funding to support the development, manufacture, and feasibility testing of two prototype core antigen (cAg) immunoassays for confirmatory hepatitis C virus diagnosis at the point of care.
Financial terms of the awards were not disclosed.
The organization is awarding funding to Qorvo Biotechnologies, in Greensboro, North Carolina, and Novel Biomarkers Catalyst Lab, in Nijmegen, the Netherlands, to support the development of prototype cartridge-based HCV cAg platforms and assays, and to assess their performance as part of feasibility projects expected to run for six months.
In its point-of-care diagnostic tests, Qorvo uses investigational bulk acoustic wave detection, while NBCL uses paramagnetic particle and chemiluminescent detection.
Geneva, Switzerland-based FIND said that in addition to funding, it will provide project support, including reference samples for assay development, antibodies for capture and detection of HCV cAg, and technical expertise.
HCV screening and diagnostic tests remain largely centralized, especially in low- and middle-income countries. Following a positive screening test, confirmatory testing is needed to establish if the person is still infected with HCV.
Rapid HCV cAg point-of-care tests, an alternative to testing in a central laboratory, are likely to be cheaper than HCV RNA detection technologies, and potentially can be used as a single-step diagnosis for chronic HCV infection in high-prevalence settings, streamlining the HCV cascade of care and reducing loss to follow up, FIND said.
Globally, more than 71 million people are chronically infected by HCV, and more than 80 percent live in low- and middle-income countries.
Four out of five people living with HCV don't know they are infected, and fewer than one in 10 have been treated, FIND CEO Catharina Boehme said in a statement.
"Simplifying the HCV diagnostic algorithm so that a confirmed result can be obtained on the spot is essential if we are going to change these sobering numbers and enable patients to begin the treatment they need as soon as possible," Boehme said. "For that we need accurate, affordable, point-of-care tests that can be administered in community settings without the need for highly trained lab staff."
The current award is part of a FIND program known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), which is supported by Unitaid, a health initiative focused on ending global health epidemics.