Ebola Diagnosis on the Fast Track

Ebola Diagnosis on the Fast Track

In addition to expedited device approvals for diseases without effective existing treatments, the FDA has also fast-tracked Ebola tests under its emergency responsibilities in the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The FDA’s announcement of emergency use authorizations (EUAs) for Ebola test kits beginning in August 2014 promoted the development of several tests by both public organizations and private industry. Test development has been along the lines of rapid diagnostics and without the time- and labor-intensive requirements common to antecedent serological and virological lab procedures for the diagnosis of Ebola.

In August 2014, the FDA issued the de facto first Ebola test EUA to the U.S. Department of Defense (DoD) for a real time reverse trancriptase polymerase chain reaction (qRT-PCR) test kit able to detect Ebola Zaire strain-specific RNA in whole Trizol-inactivated blood and plasma samples. The DoD-devleoped kit includes TaqMan probes and Trizol nucleic acid isolation reagent from Life Technologies (Thermo Fisher).

On October 10, two qRT-PCR tests from the U.S. Centers for Disease Control and Prevention (CDC) were granted EUAs: the CDC Ebola Virus NP Real-Time RT-PCR Assay and CDC Ebola Virus VP40 Real-Time RT-PCR Assay. The assays respectively target the VP40 matrix protein and nucleoprotein (NP) sequences of the Ebola Virus.

BioFire Diagnostics (bioMérieux) received the next two EUAs for Ebola on October 25, 2014. Importantly, the two BioFire EUA assays - FilmArray Biothreat-E test and FilmArray NGDS BT-E assay - can be run on moderate complexity FilmArray PCR systems. BioFire previously developed the ease-of-use, fully integrated molecular (sample preparation, amplification, detection and analysis) FilmArray system for hospital labs and other decentralized labs without CLIA high complexity certification. The FilmArray NGDS BT-E assay is for use only by DoD-designated laboratories. BioFire has a contract with the DoD to develop the FilmArray system as a biological warfare detection system.

The above FDA-EUA’d molecular assays are meaningful for introducing new standards for sensitivity and time to results in Ebola testing. Assay targeting of nucleic acids removes the complexities of interpretation and risk of cross-reaction common to immunodiagnostic tests, and supersedes the use of intensive virology tests in screening applications. Real time PCR can provide preliminary results in one hour, making a significant impact on patient handling and quarantine efforts.

Domestic Ebola testing, at hospitals and government institutions, will in all likelihood have a limited revenue impact for larger companies such as Life Technologies and bioMérieux. Similarly, Ebola tests will not factor significantly into the overall infectious disease testing market’s growth. Emergent pathogens, particularly those impacting the developing world, fail to generate significant market revenue.

The virulence of the Ebola Virus, however, combined with unknown routes of epizootic transmission and outbreak in different regions of Africa will likely prioritize its control and surveillance by the international community. In mind of likely developments in Ebola investment, Chembio begun development on a rapid Ebola test using its dual path platform (DPP) assay technology - lateral flow-like rapid immunochromatographic design - and incorporating the reagents of IBT Bioservices. A rapid immunodiagnostic test would be much more amenable to testing conditions in Africa. With Chembio’s existing international business in tests for HIV and other infectious disease, the company has could emerge as a competitor in international tenders for rapid Ebola assays.

Another key player in the development of non-molecular rapid tests for Ebola is Corgenix Medical Corporation. The company received an approximately $3 million grant in June 2014 for the development of an immunodiagnostic rapid test for the Ebola Virus. The company has a history of biologics product development and research related to hemorrhagic fever viruses (Ebola, Marburg, Lassa Fever). Corgenix may also emerge as a competitor for rapid Ebola test tenders to supply health authorities in Africa later in this decade.

Kalorama Information offers a comprehensive guide of the global infectious disease test market: The World Market for Infectious Disease Diagnostic Tests.