April 06, 2020
A Bethlehem medical technology company has received a large federal contract to create a rapid, in-home coronavirus test that can provide results within 20 minutes.
OraSure Technologies landed the $710,310 contract from the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health & Human Services.
Known for its previous self-test for HIV-1 and HIV-2, OraShore plans to use a similar portable rapid testing platform that relies on a saliva sample, without any need for instrumentation or trained personnel to administer the test.
"Lives and global economies are at stake. It's crucial that we understand just how many people are infected with SARS-coronavirus," said OraSure president and CEO Stephen S. Tang. "In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our healthcare systems and labs some much-needed breathing room."
The company anticipates it will take four to six months to develop the test, which would then be submitted to the FDA for emergency-use authorization.
Most current COVID-19 tests use nasopharyngeal or oropharyngeal swabs to collect samples. These can be painful and difficult to self-adminster. A rapid, antigen test using saliva would provide a simpler process both for lay users and medical professionals.
"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," Tang added. "We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic."
OraSure envisions making the self-test available through health care providers, retailers and online vendors that can ship it directly to peoples' homes. This would promote social distancing and enable those who take the test to determine their statuses, whether they are experiencing symptoms or are asymptomatic but positive for COVID-19.
Companies around the world are working on solutions to enhance coronavirus testing through various methods, from serology tests that detect the presence of antibodies to laboratory devices that handle a higher volume of samples with faster results.
OraSure's four- to six-month window underscores the reality that mitigation and containment strategies for COVID-19 will come in stages. More than 1.3 million people around the world have tested positive for the illness, which has claimed the lives of more than 72,600 people as of Monday afternoon. The United States surpassed 10,000 deaths from the coronavirus on Monday.
"We need to put tests into people's hands to know their infection status and protect their loved ones," said Rick Bright of the U.S. Department of Health & Human Services. "We are continually looking for transformative technologies to combat public health threats, and rapid at-home coronavirus testing would be a game-changer. We know that people can spread COVID-19 without showing any symptoms, and with rapid at-home testing people could take immediate action to prevent the spread of the virus."