Bethlehem-based OraSure Technologies Inc., a major provider of point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, saw its net revenues rise 129% in the first three months of 2023 from the previous year, to a record $155 million.
InteliSwab COVID-19 test revenue of $118.3 million increased 33% from the fourth quarter of 2022 as the company delivered record test volume supporting the federal government’s school testing program during the quarter.
With demand for InteliSwab shrinking, the global business has now begun to scale down its COVID-19 test production. The company is also in the process of closing an overseas production operation as part of its broader strategy to consolidate manufacturing.
OraSure also announced that it delivered its first OraQuick HIV Self Tests under the “Let’s Stop HIV Together” program in partnership with Emory University and the Centers for Disease Control and Prevention.
Three partnerships were announced, too:
· A new collaboration with Ziwig, a French biotech company commercializing Ziwig Endotest, a breakthrough innovation using salivary miRNA to diagnose endometriosis.
· A partnership deal with Novozymes, a global biotechnology company and world leader in biosolutions, to provide a full service offering in support of their BiomeFx product, a personalized health microbiome test.
· A commercial collaboration with nRichDX, to validate and co-promote the company’s products for their liquid biopsy applications using first-void urine samples collected by Colli-Pee urine collection device.
OraSure is guiding toward 2Q23 revenue of $62 to $67 million. Given lower April ordering activity from the U.S. government in respect to the school testing program, OraSure is guiding to InteliSwab revenue of $25 to $30 million in the second quarter representing current government program orders.
LVB: Klunk & Millan recently won an international award for its work with OraSure. Tell me more.
Gaynor: We partnered with OraSure to tackle the challenges of promoting HIV self-testing among low-income populations and high-risk groups in Sub-Saharan Africa and other international markets. The campaign focused on reducing the stigma behind HIV while highlighting the importance of getting tested. With such a taboo topic, we knew we had to approach this one differently. By lightening the mood and making the uncomfortable more comfortable, the team successfully pushed through the stigma and got people talking about HIV testing. So far the campaign has earned two international awards – a Gold 2022 Award of Excellence from The Communicator Awards and a Silver Davey Award – but more importantly, the campaign has resulted in more people knowing their HIV status.
LVB: What are some of the considerations when working on an international campaign like that?
Gaynor: With any international project, we are always mindful of different cultures, languages, and regulatory compliance. Since this particular campaign leveraged humor and light-hearted visuals, it was critical to ensure nothing was lost in translation or potentially offensive. Working closely with the global OraSure team, the creative concepts were tested with the target audience in 6 countries across Sub-Saharan Africa. When budgets allow, we always encourage research to validate strategy and/or creative direction because what resonates in one region or among a particular target audience may not resonate with another.
LVB: Are there any other interesting projects your agency is working on right now?
Gaynor: We always have a lot of interesting projects underway due to the diverse nature of our client base and the unique challenges that they are facing. We’ve been able to help our clients gain clarity on how they approach decision-making regarding marketing communications through data, discovery, and strategy. As we immerse ourselves in their businesses, we develop the skills and deeper understanding necessary to help them exceed their marketing goals and optimize their campaigns in real-time as both customer preferences and market dynamics evolve.
LVB: What are the big trends in marketing and advertising?
Gaynor: In terms of the digital space, the elimination of third-party cookies in the near future means that companies have to focus more on obtaining and leveraging first-party data to effectively communicate with their customers. Developing a solid first-party data strategy is now an important step in being prepared.
As you can tell from some of my answers, data-driven insights and problem-solving are foundational elements here at Klunk & Millan. But at the end of the day, creativity and storytelling are key to connecting brands with their target audiences. While insights from data can help inspire ideas, we can’t forget that more often than not, it’s the most personal and humanized creative campaigns that really succeed in driving home their communication strategy.
LVB: What kind of trends do you see on the horizon?
Gaynor: We’ve all seen the press recently on ChatGPT and while AI could be viewed as a threat to businesses and marketers, we view it as an opportunity. On the horizon, we anticipate the continued integration of AI technologies into the marketing and advertising toolkit. In fact, just last month, Google introduced AI-Powered Search Ads and Microsoft announced that its search engine, Bing, is now AI-powered. The Klunk & Millan team is fortunate to often be selected for beta programs that allow us to test new technologies before it becomes widely available.
While most recently the company has been making headlines for its work developing a COVID-19 test, Bethlehem’s OraSure originally gained fame for being the first to develop an at-home, oral HIV test.
With Dec. 1 being World AIDS day, the company is reaffirming its commitment to fighting AIDS, by ringing the closing bell for the Nasdaq Stock Market.
World AIDS Day is aimed to raise awareness of the AIDS epidemic and to mourn the loss of those who have died of the disease.
“OraSure has played a critical role in the fight against HIV globally since 2002. For more than two decades, we have championed the importance of access to personal information about health through easy-to-use diagnostics, particularly for vulnerable communities around the world most burdened by HIV,” said OraSure President and CEO Carrie Eglinton Manner. “Today we vow to continue that fight, both globally through partnership with non-governmental organizations that provide tests to low- and middle-income countries to help combat the HIV crisis, and domestically through innovative programs like the Centers for Disease Control and Preventions ‘Take Me Home,’ HIV self-test program.”
Under the CDC program, OraSure may supply up to one million OraQuick In-Home HIV tests to engage individuals who are disproportionately affected by HIV and less likely to have access to key diagnostic, prevention, and treatment services across the United States.
Almost 1.2 million people aged 13 and older have HIV in the United States, including an estimate of nearly 160,000, who currently do not know that they are infected.
Bethlehem-based OraSure Technologies Inc. a global developer, manufacturer and distributor of surgical and medical instruments, has been selected to provide its OraQuick In-Home HIV test to support the Centers for Disease Control and Prevention’s “Together Take Me Home” HIV self-test program.
Under the program, managed by Emory University, the CDC will provide $41.5 million over five years for community testing. Emory will collaborate with OraSure – which will provide up to 1 million OraQuick In-Home HIV tests – and other partner organizations to supply tests to U.S. communities not equitably reached by HIV testing services.
A free HIV self-test will be mailed in discreet packages to people who enroll through a website. The program will target populations disproportionately affected by HIV and less likely to have access to key prevention services.
Almost 1.2 million people aged 13 and older have HIV in the U.S., including an estimated 158,500 who are undiagnosed. “Identifying these individuals and linking them to care is a crucial element of the Ending the HIV Epidemic initiative and empowers these individuals and their communities to take control of their health care,” a release said.
The “Together Take Me Home” program follows a successful pilot program by the same name, for which OraSure also supplied tests.
“We are proud to work with the Centers for Disease Control and Emory to help support broader HIV testing and awareness in underserved communities across the United States,” said Lisa Nibauer, president of diagnostics for OraSure. Programs such as “Together Take Me Home” show that the government “can take an active role in making a difference against the major public health crises that we face as a country and to support marginalized populations.”
A COVID-19 test from OraSure Technologies Inc. of Bethlehem is going to be used in schools nationwide.
The company, which develops and manufactures point-of-care and home diagnostic testing and sample collection technologies, said that its InteliSwab COVID-19 Rapid Test has been selected by the U.S. Department of Health and Human Services to be distributed to schools across the country.
The HHS program provides school districts with at-home COVID-19 test kits to be sent home with students, teachers and staff to help keep the nation’s schools safe as the pandemic continues. Tests provided under this program will be funded as part of OraSure’s procurement contract from the Defense Logistics Agency.
“Keeping children in school is a top priority and our InteliSwab tests will help make that happen for students across the nation as they complete this school year, move through the summer and start back again in the fall,” said Lisa Nibauer, president of diagnostics for OraSure Technologies. “The InteliSwab® test is simple to use so anyone who uses it can be confident they performed the test correctly. In a pediatric specific study, 95% of parents indicated that swabbing the nose, and reading the results were easy.”
The overall accuracy of the InteliSwab test including the pediatric population is 93 percent, demonstrating comparable accuracy to that in adults.
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.
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.”
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.
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 Technologies in Bethlehem has secured a $205 million contract from the Defense Logistics Agency to supply its InteliSwab over-the-counter COVID-19 test kits as part of the national pandemic response.
Under the terms of the contract, OraSure will provide the test to up to 25,000 sites throughout the United States and the tests will be funded by the U.S. federal government. The contract will run from October 2021 through September 2022.
“We are exceptionally proud to work with the Defense Logistics Agency and the U.S. federal government to be part of the nation’s pandemic response. We strongly believe testing will play a critical role in controlling the recent outbreak of the Delta variant and help to prevent future outbreaks. We believe widespread testing will allow Americans to return to work and school safely, as well as save lives and livelihoods,” said OraSure President and CEO Stephen Tang. “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.”
The company expects to ramp up production during the remainder of 2021 to meet the contract, and so it expects most of the revenue from the contract to be coming in during 2022.
The InteliSwab which received Emergency Use Authorization from the Food & Drug Administration is used by swiping the lower nostril and gives rapid test results. The test does not need to be administered by a professional making it more convenient in non-medical settings.
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.
As the company quickly pivoted to address the COVID-19 pandemic, Bethlehem’s OraSure Technologies Inc. exited 2020 a stronger company with an 11% growth in sales — $50 million of which was in COVID-19-related testing equipment alone.
“It was easy to pivot to COVID-19 because we have expertise in that area of global pandemics,” said Stephen Tang, president and CEO.
The company even had one of its products, the OraSure OMNIgene collecting devices named as one of Time Magazine’s Best 100 Inventions of 2020.
And now the company expects even more growth, perhaps massive growth, as it looks towards 2021 and beyond.
“Our goal is to build on our success,” Tang said.
The company reported net revenue of $172 million for 2020, a number he called significant for a relatively small firm in the industry with only about 500 employees.
With the success of 2020’s product launches and products that are expected to be released in the coming months both numbers to grow in 2021
While the company has not yet released any numbers, Tang said construction is continuing at its First Street location and he expects to add a significant number of jobs this year in addition to the 170 OraSure started adding in 2020 to meet the demand for Covid-19 testing products.
The company is also preparing to submit its two COVID-19 Rapid Antigen Self-Tests to the Federal Drug Administration for Emergency Use Authorization.
The tests, one of which would be administered by medical professionals and one that is a prescription-based self-test, were called “game changers” by former Pennsylvania Health Secretary Dr. Rachel Levine. The tests detect COVID-19 antigens and return results quickly by eliminating the need for a laboratory review.
OraSure plan to seek FDA permission to sell the test for over-the-counter use. If approved, Tang said the company could begin producing the prescription and professional tests within six to eight weeks.
With three vaccines for COVID-19 now on the market in the U.S., and President Joe Biden predicting that most Americans will be able to receive vaccines by May, it may seem that such tests would be less vital, but Tang said nothing could be farther from the truth.
“The U.S. is only 4% of the world’s population. Testing will remain a key part of conquering the virus around the world,” he said. “We don’t know ultimately how many people will be vaccinated. In some parts of the world it could take years.”
He also noted that scientists are still unsure how long vaccine immunity will last or the impact COVID-19 variants may have, making testing an ongoing priority.
“It’s a mistake to think because vaccines are on the way that we’re done. We’re far from done,” he said.
Tang said OraSure has yet to release any financial guidance for 2021 because so much depends on FDA approval of its antigen test, but they’re preparing for the growth that product will bring.
To put it into perspective, Tang said, OraSure produced 80 million rapid oral HIV tests between 2004 and 2019. By the end of 2021 it will have the capacity to produce 70 million tests annually.
“That’s how remarkable our growth will be,” he said, emphasizing that most of those tests will be manufactured in Bethlehem.
But it’s not just organic growth Tang is looking at. With a strong balance sheet the company is well positioned to acquire other companies with complementary technologies that can add to what OraSure can offer.
Tang said he has his eye out for a number of acquisition opportunities that will help with his growth strategy.
“Our goal is to be a larger stronger company that we were pre-pandemic, during the pandemic and in a post-pandemic world,” Tang said.
He said the employees at OraSure have their eyes on the future, knowing that they’re not just working towards global health, but returning their own lives back to normal.
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