Emergency Approval of Ebola Test Suggests Opportunity for Test Makers

The emergency approval of a real-time PCR test for Zaire Ebolavirus demonstrates the scope of concern about the recent epidemic and a possible opportunity for test makers. The biennial study of the microbiology test product market, “The World Market for Infectious Disease Diagnostic Tests,” by Kalorama Information (New York City, NY, USA) estimated the world market for infectious disease tests at USD 5.3 billion in 2013 and expected it to grow at a slightly higher rate than the rest of the diagnostics market. The scourge of expanding infectious disease threats is part of the factor driving growth of tests. Partly due to the nature of the illness and the high mortality rate (often close to 90% in underdeveloped countries), Ebolavirus disease (EVD) outbreaks can get special international attention from the healthcare community.

Kalorama released its 2013 infectious disease market estimates as the United States Food and Drug Administration (FDA) announced emergency-use-authorization of a TaqMan-based test used by the Department of Defense (DOD). The test was made by the DOD, but is run on instruments from Thermo Fisher Scientific, originally from Carlsbad-based Life Technologies, bought by Thermo Fisher in February 2014. Results of the test, which analyzes blood samples, are available in about 2 hours, whereas other tests take days.

This rare type of emergency authorization by the FDA bypasses the agency's usual approval process. Usually this type of approval is issued during crises, like the current Ebola outbreak in West Africa. "Infectious disease is not an area where governments feel comfortable waiting for test results," said Bruce Carlson, publisher of Kalorama Information, "It's an opportunity for innovative technologies, and test makers who develop solutions in infectious diseases can benefit from the high priority placed on them by healthcare systems."

The Kalorama report covers standard tests for infectious disease, and has breakouts for test technologies and disease categories. Significant efforts in microbiology are detailed in company profiles.

Related Links:
Kalorama Information
The World Market for Infectious Disease Diagnostic Tests 
US FDA Emergency-Use-Authorization of test for Ebola Zaire Virus