OraSure Technologies of Bethlehem said it expects to launch its COVID-19 rapid antigen in-home self-test by the fourth quarter of this year.
“We are confident, given our ongoing initiative to scale up our production capacity, that OraSure will be able to deliver substantially increased volumes of collection and testing products, while ensuring that they meet the highest quality standards as we contribute to the fight against this global crisis, said Steven Tang, president and CEO of OraSure.
The test is being built on the same OraQuick platform that the company has used to create similar tests for HIV and Hepatitis C.
The release of the test would be subject to regulatory approvals, but Tang said the company “fully expects to meet or exceed applicable FDA performance guidelines.
The OraQuick Coronavirus Rapid Antigen Self-Test is a potential game-changer, Tang said. The at-home test quickly detects active COVID-19 infection at the point of sample collection with no instrumentation needed to interpret results, and no need to transport samples to a lab for analysis. Users swab their lower nostril to collect the sample and read their results a short time later.
Currently, there are no COVID-19 tests for active infection that provide a result at the point of collection with no need for a diagnostic instrument to interpret the result.
Many infectious diseases experts have been calling for faster testing options to get ahead of the COVID-19 pandemic.
OraSure pointed to a recent Rockefeller Foundation report on testing that specifically calls for rapid, convenient tests to help get to the 30 million tests per week many believe are needed by November to reduce the spread of COVID-19.
Tang said OraSure’s COVID-19 antigen self-test could become an invaluable tool for opening up economies, keeping them open, and enabling the safe return to work, school and group events.
Tang spoke during the company’s second quarter financial report, indicating that revenue was down about 25% because of the overall effects of the current pandemic.
Roberto Cuca, chief financial officer for OraSure said that while there was uncertainty about the company’s revenue for the remainder of the year because of the impact of the virus, he remained hopeful. “…We continue to anticipate that sales of our existing and new products for COVID-19 testing will offset the negative impact of the pandemic on our non-COVID-19 business.”