The agency has granted emergency use authorization to nine other Ebola tests, but OraSure's is the first that does not require refrigeration at temperatures of up to 104 degrees — an important attribute for tracking a disease that spreads in the developing world.
As the disease spread last year, doctors lacked a rapid test to quickly diagnose the flood of patients pouring into emergency rooms and treatment centers with Ebola-like symptoms. Isolating highly contagious Ebola victims is a key to preventing the spread of the disease.
"The importance is that now we have a rapid diagnostic that can be deployed near patients and give individual results in as little as four or five minutes and enable health care providers to take appropriate precautionary measures with those patients so they can reduce forward transmission, but also treat those patients," said Douglas Michels, CEO of the Bethlehem-based company.
Negative results can take up to 30 minutes.
The OraSure diagnostic was designed for use on saliva and blood, but the emergency use authorization only covers blood, both finger stick and full venous samples. Michels said the company wanted to achieve emergency authorization with the blood samples first, before moving on to saliva.
The device looks a little bit like a home pregnancy test: One line is negative, two is positive.
The special authorization lasts for as long as the U.S. Department of Health and Human Services determines there is a need to allow emergency use of such diagnostic tests. The department initially made that determination in August 2014.
The status means the OraQuick Ebola Rapid Antigen Test is cleared for "use by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics)," the company said.
In its authorization, the agency notes that the test has only been approved for use on people demonstrating symptoms of Ebola in areas where the disease is present and a rapid test is more appropriate than a traditional nucleic acid-based test, which is more accurate, but can take longer to produce a result.
It is not authorized for use in contact-tracing or airport screening.
OraSure is also working to get the test included on the World Health Organization's list of preapproved diagnostic tests, Michels said.
While the 2014 Ebola outbreak that started in West Africa has slowed considerably, new cases continue to show up in Guinea and Sierra Leone. The World Health Organization reported on July 29 that seven new cases were reported the previous week, the lowest total in a year.
The OraQuick Ebola Rapid Antigen Test is based on the same platform OraSure uses in its hepatitis C and HIV tests, but it is unlikely to provide the company with anywhere near the sales or revenue. Ebola simply isn't as common a disease, Michels said.
Mark Massaro, an analyst with Canaccord/Genuity, a Canadian global financial services company, has said that barring another outbreak, the annual market for Ebola diagnostics is likely far less than $20 million, possibly as low as $1.5 million.
"We think Ebola could add some upside to the business in 2016, as OraSure seeks to introduce a unique oral fluid/blood combo test to the market," Massaro wrote in a report on the stock in May.
But the analysis noted potential revenue increases from OraSure's hepatitis C test and partnership with drugmaker AbbVie and its growing molecular diagnostics segment are far more significant.
Now that it has emergency use authorization, OraSure plans to pursue sales to government and non-governmental agencies dealing with the disease, Michels said. The company reached a deal with the Department of Health and Human Services this year for an initial commitment of $1.8 million and options of up to an additional $8.6 million to fund clinical and regulatory activities over 39 months.
While recent news of progress on developing an Ebola vaccine is encouraging, Michels said it's too early to say what effect if any it will have on sales of OraQuick Ebola.
"Hopefully, we are not going to see another terrible outbreak like this, but now with these tools we have a way to deal with it," Michels said.
©2015 The Morning Call (Allentown, Pa.), Distributed by Tribune Content Agency, LLC.