Pennsylvania diagnostics maker OraSure Technologies is building out a tool to rapidly diagnose Ebola – and raised a significant chunk of government change to help push it through the regulatory process.
With the same technology it uses to conduct rapid HIV and hepatitis C tests, OraSure has a rapid Ebola antigen diagnostic in development. While still in prototype form, the device appears to deliver analytical performance similar to laboratory PCR tests on Ebola samples, OraSure said.
It just got a $10.4 million contract from the U.S. Department of Health and Human Services to develop the Ebola test. This includes $1.8 million upfront, and up to $8.6 million over the next three years to fund the necessary clinical and regulatory steps.
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OraSure drew revenue from selling this test to the Centers for Disease Control for investigational use in Africa. The data generated from this field testing, it said, will be used to obtain an Emergency Use Authorization from the FDA in the coming months.
The World Health Organization and CDC have outlined the need for an Ebola diagnostic. The WHO wrote last November:
The standard molecular assays currently used in mobile and other laboratories supporting the Ebola response include the reverse-transcriptase polymerase chain reaction, or RT-PCR test. The test, which involves a number of laborious procedures, provides very accurate results when performed by trained staff. Each test requires a full tube of blood, takes from 2 to 6 hours, and costs around $100. These requirements are difficult to meet in resource-constrained West African settings, thus severely limiting testing capacity.
The general conceit of the OraSure device is to make Ebola diagnostics more accessible at point-of-care.
