By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Rapid diagnosis of infectious pathogens is key to controlling outbreaks. Time to diagnosis is particularly critical for deadly infections such as Ebola. The U.S. Department of Health and Human Services’ (HHS’) office for preparedness and response announced a $1.8 million contract with OraSure Technologies (Bethlehem, Penn.) for further development of a point-of-care (POC) test for Ebola that can deliver results within 20 minutes. Such a test would make rapid Ebola diagnosis possible anywhere in the world—including in clinics, hospitals, or in remote field locations.
Quick results enable faster isolation of Ebola-infected patients, which could limit the further spread of the disease. The OraQuick rapid Ebola antigen test, currently under development, utilizes lateral flow technology. The simple, low-cost test can be performed with just a drop of blood or saliva and leverages OraSure’s technology platform used with the company’s HIV and hepatitis C virus test kits.
The company says the multi-phased contract includes an initial commitment of $1.8 million with options for up to an additional $8.6 million over 39 months. The agreement supports clinical and non-clinical work necessary to ready the test for approval by the U.S. Food and Drug Administration (FDA).
OraSure previously announced it completed the design of a prototype device that delivers analytical performance similar to laboratory polymerase chain reaction tests, the current gold standard for Ebola diagnosis. The prototype device tested stored samples from infected patients. OraSure also reported in its first quarter financial statements revenues from the initial sales of this product to the U.S. Centers for Disease Control and Prevention for investigational use in Africa. Data generated from this field testing, along with other studies will be used to apply for Emergency Use Authorization from the FDA in the next several months.
HHS also says OraSure will evaluate whether the POC test is effective for the post-mortem analysis of oral fluids. With the latest Ebola outbreak in Africa diagnosis was not always possible before death and corpses remain highly infectious. Rapid post-mortem diagnosis would ensure proper handling of infected corpses.
HHS says the OraQuick rapid Ebola antigen test is the first POC Ebola testing device to receive financial support from its Biomedical Advanced Research and Development Authority (BARDA). BARDA is seeking additional proposals as part of its commitment to advancing development of vaccines, diagnostics, therapeutics, and other tools to combat public health emergency threats.