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Tag: InteliSwab

OraSure cuts ribbon on COVID-19 test manufacturing facility

Local officials gather to cut the ribbon at Opus Way, OraSure Technologies new COVID-19 rabid test manufacturing facility. PHOTO/SUBMITTED –

OraSure Technologies has officially cut the ribbon on Opus Way, its new expanded facility in Bethlehem Township, which was constructed with the help of $109 million from the U.S. Department of Defense (DOD) to ramp up production of InteliSwab COVID-19 rapid tests as part of the nation’s pandemic preparedness plan. 

“We have built the capacity to manufacture almost as many tests in a single week as we used to produce in an entire year … and we will continue to ramp production as we bring this new facility fully online,” said Carrie Eglinton Manner, president and CEO of OraSure Technologies. 

She called Opus Way a team effort – both within the organization and through OraSure’s partnerships with the federal and state government.  

“It is because of this collaboration that we are here together today for our official ribbon-cutting ceremony,” she said. 

OraSure was awarded a total of three contracts from the federal government last year to help develop, produce and distribute the COVID-19 test. Those included $205 million for InteliSwab COVID-19 Rapid Test procurement, $109 million for InteliSwab manufacturing capacity build out, and $13.6 million to pursue full FDA 510(k) clearance for InteliSwab. 

“These contracts position OraSure as an important part of the government’s global pandemic response,” said Lisa Nibauer, OraSure’s president of Diagnostics. “The U.S. government’s selection of OraSure’s InteliSwab rapid test for their national pandemic preparedness effort is a great honor.” 

OraSure test can now be used for children as young as 2 years

OraSure’s InteliSwab can now be used by children as young as 2 years old. PHOTO/SUBMITTED –

OraSure Technologies of Bethlehem has announced that its rapid COVID-19 test, InteliSwab, has been authorized by the FDA for use in children ages 2 to 14. InteliSwab was previously authorized for use in adults and in children 15 to 17 when administered by an adult. OraSure also confirmed that InteliSwab detects the Omicron variant, the Delta variant and other variants of concern. 

As part of its submission to the FDA for this label expansion, the company conducted studies to evaluate the performance of the test in a pediatric population, as well as studies to evaluate usability and tolerability by children. From a combined performance perspective, InteliSwab was shown to have 85 percent positive percent agreement (PPA) for individuals ages 2 and up and 98 percent negative percent agreement (NPA). 

The overall accuracy of the InteliSwab The overall accuracy of the InteliSwab® test including a pediatric population is 93 percent, demonstrating similar accuracy when compared to the Company’s clinical studies in adults. OraSure also evaluated the usability and acceptability of the test in children. In the usability study, parents were able to use the test on children error free 96 percent of the time, demonstrating the exceptional ease of use of the test. The test was also well accepted by children across a broad age range. 

“Helping our children stay in school and get back to normal is crucial to their wellbeing and continued development,” said OraSure President and CEO Stephen Tang, Ph.D. “Fast, frequent testing is a key component to making this happen and we are delighted that our InteliSwab® test can now be used for children. The test is accurate and easy to use, so caregivers can feel confident when they choose to use this test on a child.”  

The overall accuracy of the InteliSwab test including a pediatric population is 93 percent, demonstrating similar accuracy when compared to the company’s clinical studies in adults.  

OraSure also evaluated the usability and acceptability of the test in children. In the usability study, parents were able to use the test on children error free 96 percent of the time, demonstrating the exceptional ease of use of the test. The test was also well accepted by children across a broad age range. 

“Helping our children stay in school and get back to normal is crucial to their wellbeing and continued development,” said OraSure president and CEO Stephen Tang. “Fast, frequent testing is a key component to making this happen and we are delighted that our InteliSwab test can now be used for children. The test is accurate and easy to use, so caregivers can feel confident when they choose to use this test on a child.” 

Additionally, the company said it has launched a reporting app, InteliSwab Connect, which will allow people to easily report their test results to public health authorities, helping communities monitor for an increase in cases and employers track prevalence in the workplace. 

 

FDA approves single testing for OraSure’s COVID-19 rapid test

The U.S. Food & Drug Administration has amended its Emergency Use Authorization of OraSure’s InteliSwab COVID-19 rapid test. The Bethlehem diagnostic test manufacturer said the EUA now only requires one test for users who are presenting symptoms of COVID-19. 

Previously, the at-home test was authorized for over-the-counter use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests, which is called serial testing. Now, people with symptoms only need to test once. 

 People without symptoms, however, should still perform serial testing if they get a negative result on their first test. 

In addition, OraSure conducted studies using live SARS-CoV-2 virus at independent laboratories that showed detection of all variants of concern, including the Delta variant.  

The FDA reviewed the data submitted by OraSure regarding the detection of the SARS CoV-2 Delta variant and indicated it was adequate, and that no further data was required. 

“These studies in independent labs clearly show the InteliSwab tests detect variants, including the Delta variant that roared through the country late this summer, and this should give people extra confidence in the accuracy of InteliSwab,” said OraSure President and CEO Stephen Tang. “Beyond that, the authorization of the InteliSwab COVID-19 Rapid Test to be used as a one-time, over-the-counter test for people with COVID-19 symptoms will help increase our nationwide availability of tests, ensuring people who want rapid tests have access to them.” 

 

Defense Dept. gives OraSure $109M to ramp up COVID-19 test manufacturing

OraSure Technologies Inc. has been awarded a $109 million contract from the U.S. Department of Defense to build additional manufacturing capacity for its InteliSwab COVID-19 rapid tests as part of the nation’s pandemic readiness plan. 

The federal funding will expand OraSure’s production capacity by 100 million tests annually, by March 2024. An existing OraSure location in Bethlehem will be retrofitted to accommodate increased manufacturing and an additional new facility will be added in another U.S. location yet been determined.  

“The U.S. government’s selection of OraSure’s InteliSwab rapid test for this national pandemic preparedness effort is a great honor and ensures we can make the necessary investments to scale manufacturing in order to support our nation’s pandemic response,” said OraSure President and CEO Stephen Tang. “This test will play a key role in ensuring our nation is prepared to continue the fight against this, and possible future pandemics and potential resurgences in disease activity.” 

OraSure also has internally funded expansion plans to achieve production of 120 million tests annually by the second quarter of 2022. 

“Home testing options prevent the risk of further spread of the virus, and minimize the burden on the individual, making them an ideal cornerstone of any national pandemic preparedness strategy,” Tang said. “As a company we stand ready to aid in the government’s efforts to allow individuals to return to work and school safely. Beyond that, this funding will allow OraSure to respond to future public health crises.” 

The contract comes on the heels of two recent announcements in which the Bethlehem company was awarded a $205 million contract from the Defense Logistics Agency to supply its InteliSwab over-the-counter COVID-19 test kits. It also received funding from the Biomedical Advanced Research Development Authority. 

That authority recently announced that it will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and CLIA waiver for the test. 

It was granted three Emergency Use Authorizations by the Food and Drug Administration in June for professional point-of-care use, prescription home use, and over-the-counter use. 

 

OraSure receives funding to further COVID-19 test clearance

Just days after announcing that it had received a $205 million federal contract to provide COVID-19 InteliSwab tests, Bethlehem’s OraSure said the Biomedical Advanced Research Development Authority (BARDA) will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and CLIA waiver for their COVID-19 rapid test, InteliSwab, from the Food & Drug Administration. 

The test is currently being manufactured and distributed under Emergency Use Authorization from the FDA. 

“Rapid COVID-19 antigen tests can help to facilitate containment and minimize outbreaks by detecting those individuals infected with COVID-19. 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,” said OraSure President and CEO, Stephen Tang, Ph.D. “Once received, this full regulatory clearance will help ensure continued availability of the InteliSwab COVID-19 Rapid Test long-term.” 

The advantage of the InteliSwab test is that it can be performed by a non-professional outside of a medical setting. A user swipes the lower nostril with the test swab and receives results in about 30 minutes, providing a quick answer as to whether or not someone is infected. 

Following 510(k) clearance, Tang said the company will pursue Clinical Laboratory Improvement Amendments (CLIA) waiver for InteliSwab, to ensure that the test can continue to be performed by an untrained user outside of the laboratory setting. 

OraSure’s rapid COVID-19 antigen test receives FDA approval

It’s the news Bethlehem’s OraSure Technologies Inc. has been waiting for. It announced today that it has received three Emergency Use Authorizations from the Federal Drug Administration for its COVID-19 rapid antigen tests.

The tests, which will be branded as InteliSwab, are easy-to-use tests that are authorized for over-the-counter use without a prescription as well as for prescription use and use by a professional health care provider in a medical setting.

These are the tests that former Pennsylvania Health Secretary Rachel Levine referred to as “a game changer” in the fight against COVID-19

The InteliSwab has a built-in swab that is fully integrated into the test stick, simplifying the entire testing process and making it easy to use in home, work or school settings.

To test for COVID-19 antigens, users swab their lower nostrils with the test stick and then swirl it in a pre-measured solution. The testing process takes less than a minute and people can see their result on the test stick in 30 minutes. No instruments, batteries, smartphone or laboratory analysis are needed to see the result.

The introduction of InteliSwab helps with the overall supply of tests because it does not require sourcing scarce nasal swabs.

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

“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. 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 that in a clinical study of InteliSwab, the test had strong performance, with positive results agreeing with highly sensitive FDA-authorized PCR tests 84% of the time, and negative results agreeing 98% of the time.

In addition, 98% of consumers in the clinical trial found InteliSwab easy-to-use.

At current capacity, OraSure is able to manufacture 55 million test units annually.

The company, however, will be ramping up to a production capacity of 70 million units annually in the third quarter of this year.

Last August, Tang announced the company planned a more than $7 million expansion to increase production.

He also said the company planned to add 177 employees to its payroll, largely in manufacturing, quality control and regulatory affairs. That nearly doubles the number of employees the company had pre-pandemic.

The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.

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