BETHLEHEM, Pa. – Amid a devastating Ebola outbreak in Africa, a Lehigh Valley company is racing to get a critical test into the hands of healthcare workers on the frontlines.
Bethlehem’s OraSure has submitted for emergency use authorization from the U.S. Food and Drug Administration (FDA) for its second generation OraQuick Ebola 2.0 Rapid Antigen Test.
The medtech company currently offers a similar test that has a de novo authorization from the FDA. De novo (Latin for “anew”) authorization helps new medical devices that are considered low risk get to market faster.
The FDA originally granted emergency use authorization for the OraQuick Ebola test in 2014 so healthcare workers could use it during an Ebola outbreak in West Africa that year. It was granted de novo authorization in 2019.
A spokesperson for OraSure told 69 News the newer version of the test has improved analytical sensitivity, longer shelf life and more automation.
According to OraSure’s website, the single-use test detects virus antigens in blood samples that can be obtained through either venipuncture or finger stick. It can also be used with oral fluids taken from those who are suspected to have died from Ebola.
Positive results may appear within minutes; negative results require waiting a full 30 minutes.
The OraQuick Ebola Rapid Antigen Test is manufactured in Bethlehem.
The spokesperson said the latest FDA submission is currently under review.
The current Ebola outbreak is ravaging the Democratic Republic of the Congo (DRC) and Uganda, with one case reported in France.
According to the World Health Organization (WHO), as of June 29, there were 1,354 cases of Ebola confirmed, with the majority of those cases in the DRC.
401 patients have died, the WHO said.
The current Ebola outbreak is the third-largest on record.