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OraSure Technologies Gets FDA Authorization for COVID-19 Test

By Colin McEvoy on June 8, 2021

InteliSwab, an over-the-counter test by OraSure Technologies that has been authorized for use without a prescription, can be used with a simple swab in the lower nostril

InteliSwab, an over-the-counter test by OraSure Technologies that has been authorized for use without a prescription, can be used with a simple swab in the lower nostril

OraSure Technologies has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen tests, which are known as InteliSwab and are designed for home use without the presence of a healthcare professional.

The over-the-counter tests have been authorized for use without a prescription, and can be used with a simple swab in the lower nostril. The InteliSwab stick requires less than one minute of hands-on time, and the result can be viewed on the test stick in 30 minutes.

“OraSure is on a mission to make COVID-19 testing dramatically simpler,” said OraSure President & CEO Stephen Tang. “We believe that this easy and intuitive ‘swab, swirl and see’ test will be one of the simplest COVID-19 tests on the market.”

The Bethlehem-based OraSure Technologies, a developer and manufacturer of point-of-care diagnostic tests and specimen collection devices, has received national attention for the development of its innovative COVID-19 test. It was the subject of a CBS News Sunday Morning television program in December.

OraSure Technologies President & CEO Stephen Tang

The unique design of InteliSwab incorporates a built-in swab that is fully integrated into the test stick, simplifying the entire testing process, Tang said.

“Our scientists have designed a rapid COVID-19 test so remarkably simple it puts the power of a lab in your hands,” states an OraSure video demonstrating the product. “It’s InteliSwab, the anywhere, anytime COVID-19 home test that’s so easy to use, you’ll know you did it right.”

No instruments, batteries, smartphone, or laboratory analysis is required to see the test result.

“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.

In a clinical study at five independent U.S. sites, InteliSwab had strong performance, according to the company. Positive results from InteliSwab agreed with highly sensitive FDA-authorized PCR tests 84% of the time, and negative results agreed 98% of the time.

Additionally, 98% of consumers in the clinical trial found InteliSwab easy to use, Tang said.

“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,” he said. “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.”

OraSure announced in August plans to expand its manufacturing operations in Lehigh Valley to help meet demands for the new in-home coronavirus self-test. The company said expansion would mean the creation and retention of more than 400 jobs in the region.

OraSure’s installed manufacturing capacity for InteliSwab is currently 55 million units annually. The company will be ramping up to a production capacity of 70 million units annually in the third quarter of 2021.

The Lehigh Valley is home to 174 establishments in the life sciences sector as of Q4 2020, employing more than 6,300 people and with an average annual wage of $94,100, according to Chmura Economics.

In the last two years, Lehigh Valley companies have undertaken projects that will add or have added at least 1.3 million square feet of space related to the life sciences in Lehigh and Northampton counties.

Lehigh Valley’s employment concentration among manufacturers of diagnostic devices, such as OraSure Technologies, is more than twice the size of the typical U.S. region, according to LVEDC Director of Research & Communications Nicole Radzievich Mertz Director.

OraSure will market three versions of InteliSwab. The InteliSwab COVID-19 Rapid Test, an over-the-counter home test, is for use in individuals 15 years or older (with or without symptoms) when tested twice over two or three days with at least 24 and no more than 36 hours between tests.

The other versions are the InteliSwab COVID-19 Rapid Test Pro, which is packaged in bulk configuration and for use at the point of care in healthcare settings, and the InteliSwab COVID-19 Rapid Test Rx, a prescription home test for individuals suspected of infection by their healthcare provider within the first seven days of symptom onset.

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