Feds bet $327.6M on rapid COVID test from Bethlehem’s OraSure – lehighvalleylive.com

Bethlehem-based OraSure Technologies Inc. describes its InteliSwab COVID-19 rapid test as a simple “swab, swirl and see” test that uses an integrated swab to self-collect a sample from the lower nostrils. The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed.Courtesy photo | For lehighvalleylive.com
The No. 1 national strategy for bringing the coronavirus pandemic to heel is vaccinations, but the federal government wants to see more robust testing for COVID-19, as well.
Bethlehem-based OraSure Technologies Inc. is poised to play a big role in helping people learn whether they’re infected, with quick results and a less invasive testing procedure than the widely used deep-nasal-cavity swabbing.
To get more of OraSure’s InteliSwab COVID-19 rapid tests into the hands of the public and medical professionals, the federal government in recent weeks awarded a combined $327.6 million in funding to the Southside company.
“Rapid COVID-19 antigen tests can help to facilitate containment and minimize outbreaks by detecting those individuals infected with COVID-19,” OraSure President and CEO Stephen Tang said in a statement last month. “Testing with InteliSwab is expected to be an important component of governments’, private industries’ and communities’ response to the COVID-19 pandemic, along with vaccination and protection.”
OraSure describes InteliSwab as a simple “swab, swirl and see” test that uses an integrated swab to self-collect a sample from the lower nostrils. The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed.
The test has three Emergency Use Authorizations from the U.S. Food and Drug Administration, for professional point-of-care use, prescription home use and over-the-counter use. OraSure announced Sept. 23 it received $13.6 million from the federal Biomedical Advanced Research Development Authority to go toward obtaining new federal clearances.
One clearance, known as 510(k) from the FDA, would allow the InteliSwab kits to be marketed without a public health emergency declaration from the Secretary of the federal Department of Health and Human Services. Following 510(k) clearance, OraSure said it will pursue a waiver under federal Clinical Laboratory Improvement Amendments ensuring the test can continue to be performed by an untrained user outside of the laboratory setting, according to a news release from the company.
Consumers can find InteliSwab kits for sale now, OraSure says, including through Walgreens at $23.99 for a two-pack. Individual retailers will set the rates for their stores, according to OraSure.
The company now is ramping up production and expects the tests’ availability to continue to increase through the rest of this year and into 2022 and 2023.
That’s, in part, where another $109 million from the federal government comes in to play.
OraSure announced Oct. 4 it was awarded a contract in that amount from the U.S. Department of Defense in coordination with the Department of Health and Human Services to build additional manufacturing capacity in the United States for its COVID-19 tests.
The funding will expand OraSure’s production capacity by 100 million tests annually, by March 2024, the company said. That will be accomplished by retrofitting an existing OraSure facility in the Lehigh Valley Industrial Park off Brodhead Road outside Bethlehem, and by adding an additional new facility in another domestic location to be determined, according to the company. In addition to this contract, OraSure has internally funded expansion plans to achieve 120 million tests annually by the second quarter of 2022.
OraSure has not disclosed how many jobs the expanded manufacturing capacity will create, but a representative says “it will entail a significant hiring effort.”
The third round of federal aid recently announced by OraSure is an estimated $205 million procurement contract for the InteliSwab COVID-19 Rapid Test, from the federal Defense Logistics Agency. Under the contract running from this month through September 2022, the kits will be distributed to up to 25,000 sites throughout the United States for testing funded by the federal government, OraSure announced.
“We believe widespread testing will allow Americans to return to work and school safely, as well as save lives and livelihoods,” Tang said in announcing that contract. “InteliSwab is uniquely suited to fulfill this mission as it was designed to be one of the simplest rapid antigen tests. Its intuitive nature makes it ideal for use in underserved communities and consumer testing settings throughout the U.S.”
OraSure together with its wholly owned subsidiaries DNA Genotek, Diversigen and Novosanis work to provide customers with end-to-end health and wellness solutions that encompass tools, services and diagnostics. Founded in 1987 in Bethlehem, the company has previously tackled rapid testing for diseases like HIV, Hepatitis C, ebola and Zika.
In general, the U.S. has been far more cautious about embracing rapid, at-home testing technology compared to countries like Britain that have rolled it out widely. The FDA has authorized only about a half-dozen such tests, compared with more than 400 laboratory tests. Many experts, including FDA regulators, still consider laboratory technology the “gold standard” for accuracy because it can detect even minute levels of virus in the nose.
But in his speech this month announcing sweeping new vaccine mandates, President Joe Biden highlighted rapid tests, saying the government would purchase 280 million of them, as he also called on all schools to set up regular testing programs. Biden said the federal government will use the Defense Production Act to ensure manufacturers have the raw materials they need to make tests.
A spokeswoman for the Department of Health and Human Services last month said a $2 billion-plan to purchase rapid tests and other actions “build on earlier initiatives” as the delta variant-driven surge boosts testing demand.
The Associated Press contributed to this report.
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Kurt Bresswein may be reached at [email protected].
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