OraSure Technologies on the Front Lines in Fight Against Coronavirus

By Colin McEvoy on May 5, 2020

As the nation grapples with quarantines and millions of employees are telecommuting during the COVID-19 pandemic, the Lehigh Valley has a high percentage of essential jobs that cannot be done from home. Each week, we’re recognizing some of our Economic Heroes, the companies and organizations that are continuing to work during these difficult times, helping keep the regional economy strong and doing their part to help fight against the coronavirus.

OraSure Technologies is developing an oral fluid pan-SARS-coronavirus self-test. (image courtesy OraSure Technologies)

When it comes to public health crises, OraSure Technologies has always been on the front lines.

The Bethlehem company was the first to develop an in-home oral HIV test for over-the-counter use. When the Ebola virus was ravaging West Africa five years ago, the federal government sought OraSure’s help in designing a rapid test to screen patients.

Now, the national leader in point-of-care diagnostic tests and specimen collection devices is stepping up to the plate once more, developing an oral fluid pan-SARS-coronavirus self-test. Individuals will be able to administer the tests themselves and read the results in the privacy and safety of their own homes.

The coronavirus antigen self-test will use oral fluid samples, and will detect current infection regardless if a person is showing symptoms. “Real-time infection status data are crucial to getting our economy fully operational again,” said Stephen S. Tang, Ph.D., OraSure’s President and CEO. “OraSure has the experience needed to create a scalable solution for widespread COVID-19 testing that can quickly confirm individuals to be virus-free and able to return to work.”

Last month, OraSure received a $710,310 contract from the U.S. Department of Health and Human Services to develop the test, which will be available for use for in-home self-testing by lay users as well as by medical professionals.

The test is currently being developed, with an anticipated 3 to 5 months before emergency use authorization by the U.S. Food and Drug Administration. In the meantime, OraSure is planning for manufacturing scale-up and distribution, Tang said.

No instrumentation or trained personnel will be needed to administer the test or to read the results, Tang said. In-home self-testing will dramatically increase the capacity for testing and will significantly alleviate pressure on the federal health care system.

Stephen Tang

“We are committed to making a difference in the world of individual and public health by enabling access to discovery and diagnostics,” Tang said. “We are exceptionally proud of the work that we do right here in the Lehigh Valley to accomplish our mission.”

Even as development of the coronavirus self-test is ongoing, OraSure is continuing to manufacture its other products, including the HIV self-test which is manufactured in the company’s south Bethlehem facility.

“The COVID-19 project is a top priority, but we’re not taking our eye off of the rest of our product line,” Tang said. “Production of our current products continues.”

All OraSure Technologies employees are currently working despite the pandemic, Tang said. Employees whose role can be done remotely have been telecommuting since mid-March to help protect the health of those whose roles require them to be onsite.

“The health and safety of our employees is a top priority,” Tang said, adding that OraSure is following appropriate government guidelines in all of its global locations, which include offices in the United States, Canada, and Belgium.

Distribution plans for the test have not yet been determined. Depending on regulatory approvals, the COVID-19 product could be sold through public health distribution, online sales, and/or in retail pharmacies, like OraSure’s HIV self-tests, Tang said.

The company also expects interest from employers, schools, and other large volume purchasers, who want to ensure the health of their workforces.

“With millions of COVID-19 cases globally, innovative solutions are needed,” Tang said. “As active citizens of our global public health community, OraSure Technologies is proud to bring our proven expertise in developing and delivering rapid at-home tests for infectious disease like HIV to the battle against COVID-19.”

Tang said being headquartered in the Lehigh Valley has been a tremendous asset for the company, particularly due to its close proximity to other major metropolitan areas in the Northeast, and the excellent pool of talented workers being generated by the region’s robust educational system.

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