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Ebola Test Development Continues, Despite Declines in Cases

by | Oct 13, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies

Despite declines in current cases in Africa, interest remains high for development and validation for a rapid, point-of-care diagnostic test for Ebola. The federal government is funding test development, researchers are publishing results of proof-of-principle and field validation studies, and companies are continuing the process of securing regulatory approval for rapid tests. In late September, OraSure Technologies (Bethlehem, Penn.) announced it received $7.2 million of continued funding from the Biomedical Advanced Research Development Authority for "clinical and regulatory activities" necessary to secure U.S. Food and Drug Administration (FDA) approval for its OraQuick Ebola Rapid Antigen test, which previously received emergency use authorization (EUA) from the FDA. The company simultaneously announced the U.S. Centers for Disease Control and Prevention is purchasing an additional $1.5 million worth of the test for further field testing. The antigen-based, fingerstick test is read visually and does not require refrigeration or instrumentation, making the test potentially, much more widely available than the current polymerase-chain reaction-based testing. Expanded Purpose for Existing EUA Assays The polymerase chain reaction- (PCR-) based assays currently granted EUA were intended for use with blood samples. However, recent evidence suggests the first case of transmission of the virus through the semen of survivors […]

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