Lehigh Valley HealthCare Innovators: On Frontlines Battle Covid-19 

OraSure Technologies, Inc., Scores Grant to Develop In-Home Covid-19 Rapid Tests

A Bethlehem-based biotech company is poised to help millions of people around the world to leave home safely–with sights on early to late fall for FDA Emergency Use Approval.

Nearly two decades before COVID-19 halted life as we know it, OraSure Technologies, Inc., was proving bio-scientific prowess as a noted leader in rapid oral testing and diagnostics.

Based in South Bethlehem, OraSure’s products have been on the frontlines of fighting the most infectious diseases on the planet–from HIV to Ebola and Hep C, and that’s just for starters. Now, user-friendly, pain-free COVID-19 rapid testing is in the works.

In early April, OraSure was awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (H.H.S.), to develop a pan-SARS-coronavirus antigen rapid in-home self-test.

With no available vaccine, testing remains vital across the globe. 

“We need to put tests into people’s hands to know their infection status and protect their loved ones. At BARDA, we are continually looking for transformative technologies to combat public health threats, and rapid at-home coronavirus testing would be a game-changer,” said BARDA Director Rick Bright, Ph.D. 

For instance, OraSure’s oral fluid self-test for HIV is used to diagnose millions of people around the world and connect them to life-saving care.

“OraSure is proud to bring its experience and expertise with rapid at-home testing to the fight against the COVID-19 pandemic. Our dedicated and capable team is working tirelessly, and it’s all hands on deck for this important initiative,” said Jeanne Mell, Vice President of Communications, OraSure Technologies. 

OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes.  

For instance, the OraQuick in-home HIV test is an over-the-counter product, according to Mell. It is available online and via retailers such as Target and Walgreens. “We also have a version of the test that is made available through healthcare professionals,” she said.

Depending on regulatory approvals, like our HIV products, the COVID-19 product could be sold through public health distribution, online sales, and/or in retail pharmacies. We also expect interest from employers and other large-volume purchasers, who want to ensure the health of their workforces. And like our HIV self-tests, this rapid test for COVID-19 would allow for in-home self-testing by lay users (like you and me) as well as by medical professionals. No instrumentation or trained personnel would be needed to administer the test or to read the results,” adds Mell.

Most current coronavirus tests require a nasopharyngeal or oropharyngeal sample, which can be painful to collect and difficult to attain through self-sampling.

Or, for instance, the company, Abbott Laboratories is currently easing the burden of COVID-19 testing with a new pain-free test; however, the Abbott machine requires a health care provider, a clinical setting, and can only test a maximum of four patients per hour per device. 

Additionally, OraSure’s technology helps maintain social distancing and curbs the spread of coronavirus through the symptomatic and asymptomatic transmission. Rapid in-home testing also eases the burden on lab-based testing.

“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 Chief Executive Officer Stephen S. Tang, Ph.D.

“An easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates. We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic,” added Tang.

And while OraSure is unable to comment on the individuals who serve as lead researchers and biotech developers, one acquaintance of the team says, “They are the most talented researchers in the world, and these hardworking, humble people are living and making a positive global impact from right here in the Lehigh Valley.”

For more information about OraSure, visit www.orasure.com.