It’s the news Bethlehem’s OraSure Technologies Inc. has been waiting for. It announced today that it has received three Emergency Use Authorizations from the Federal Drug Administration for its COVID-19 rapid antigen tests.
The tests, which will be branded as InteliSwab, are easy-to-use tests that are authorized for over-the-counter use without a prescription as well as for prescription use and use by a professional health care provider in a medical setting.
These are the tests that former Pennsylvania Health Secretary Rachel Levine referred to as “a game changer” in the fight against COVID-19
The InteliSwab has a built-in swab that is fully integrated into the test stick, simplifying the entire testing process and making it easy to use in home, work or school settings.
To test for COVID-19 antigens, users swab their lower nostrils with the test stick and then swirl it in a pre-measured solution. The testing process takes less than a minute and people can see their result on the test stick in 30 minutes. No instruments, batteries, smartphone or laboratory analysis are needed to see the result.
The introduction of InteliSwab helps with the overall supply of tests because it does not require sourcing scarce nasal swabs.
“OraSure is on a mission to make COVID-19 testing dramatically simpler. We believe that this easy and intuitive ‘swab, swirl and see’ test will be one of the simplest COVID-19 tests on the market. We expect that InteliSwab’s simplicity and accuracy will give users peace of mind that they performed the test correctly and can rely on the results,” said OraSure President and CEO Stephen Tang.
“Simple and accessible at-home tests like InteliSwab make it easier for individuals to know if they are infectious and to quickly self-isolate if they test positive. With InteliSwab, we believe OraSure will play an even larger role in safely reopening – and keeping open – workplaces, schools and other places where people congregate.”
Tang said that in a clinical study of InteliSwab, the test had strong performance, with positive results agreeing with highly sensitive FDA-authorized PCR tests 84% of the time, and negative results agreeing 98% of the time.
In addition, 98% of consumers in the clinical trial found InteliSwab easy-to-use.
At current capacity, OraSure is able to manufacture 55 million test units annually.
The company, however, will be ramping up to a production capacity of 70 million units annually in the third quarter of this year.
Last August, Tang announced the company planned a more than $7 million expansion to increase production.
He also said the company planned to add 177 employees to its payroll, largely in manufacturing, quality control and regulatory affairs. That nearly doubles the number of employees the company had pre-pandemic.
The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.