A Bethlehem company known for developing medical diagnostic tests for major diseases such as HIV and Ebola has now set its sights on COVID-19.
OraSure Technologies of Bethlehem said it earned a $710,310 contract from the federal Biomedical Advanced Research and Development Authority to develop a pan-SARS-coronavirus antigen rapid in-home self-test. The test uses saliva samples and provides results in 20 minutes.
The grant will help OraSure file for Federal Drug Administration Emergency Use Authorization, allowing for an in-home self-test to debut in the U.S. market. The development cycle should take about four to six months before OraSure can seek that emergency authorization.
The test does not require trained personnel to administer it or read the results.
Once the company develops the test and obtains necessary approvals, health care providers, retailers, and online vendors could ship tests directly to a person’s home.
This would help maintain social distancing, ease the burden on lab-based testing, and curb the spread of COVID-19, the company said.
“Lives and global economies are at stake,” said OraSure President and CEO Stephen S. Tang. “It’s crucial that we understand just how many people are infected with SARS-coronavirus. In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our health care systems and labs some much-needed breathing room. We believe that the development of an easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates.”
Since the only current COVID-19 tests available are those that force people to have to leave their homes, Tang told Lehigh Valley Business there are more people who aren’t being tested. Having an at-home test would greatly impact infection rates, he added.
“I think we could have an enormous impact,” Tang said. “We can get a better idea of what the real infection rate is.”
The reason OraSure chose an antigen test is because it shows who has an active infection, he added.
Tang cited data from Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who said about 25 percent to 50 percent of people in the U.S. are infectious with COVID-19 while being asymptomatic.
“We think we can counter that by having the test widely available,” Tang said. “We have a rich history of innovation.”
He spoke about the previous tests the company created for HIV and Ebola.
“It was very natural for us to begin investigating how that can apply for COVID-19. I think every company is racing against time to make sure the damage is minimized by this disease. The sooner we get this on the market, the more people it will impact sooner, the better we will be.”
Once the product launches in the U.S. in four to six months, OraSure can distribute it throughout the nation and globally.