InteliSwab® COVID-19 Rapid Tests Receive U.S. FDA Authorization for Pediatric Use and Company Launches New InteliSwab® Connect Reporting App
OraSure Technologies (NASDAQ: OSUR) announced FDA authorization for its InteliSwab® COVID-19 rapid tests for children aged 2 to 14. The tests demonstrated an 85% positive percent agreement and 93% overall accuracy, highlighting their usability with a 96% success rate in administration by parents. The launch of InteliSwab® Connect reporting app was also announced to aid in COVID-19 prevalence tracking. These developments are significant for increasing testing access among children and supporting public health efforts.
- FDA authorization for use of InteliSwab® COVID-19 tests in children aged 2-14.
- InteliSwab® exhibits 85% positive percent agreement and 93% overall accuracy.
- 96% error-free administration rate by parents indicates ease of use.
- Launch of InteliSwab® Connect app enhances community testing efforts.
- None.
Data Demonstrates InteliSwab® is Accurate, Easy to Use, and Well Accepted by Children
BETHLEHEM, Pa., Jan. 31, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that its InteliSwab® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (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.
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® 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.”
In addition, the Company also announced today the launch of a new reporting app, InteliSwab® Connect, which will allow people to easily report their test results to public health authorities, helping communities with COVID-19 prevalence surveillance efforts. It can also help employers track prevalence in the workplace. The app will be available on the Apple App Store and via Google Play.
About InteliSwab®
OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab® COVID-19 rapid tests. The FDA has authorized the InteliSwab® COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. The FDA has also authorized the InteliSwab® COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab® COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab®’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as “Swab, Swirl, and See.”
This product has not been FDA cleared or approved, but it has been authorized by the FDA under an EUA. The emergency use of this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Multiple government agencies, including the U.S. Department of Defense (DoD) and Department of Health and Human Services (HHS) are working to address COVID-19 testing needs. Development of the InteliSwab® COVID-19 Rapid Test has been funded in whole or in part with federal funds from the HHS; the Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract numbers 75A50120C00061 and 75A50121C00078, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab® COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). The manufacturing effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.
OraSure’s Response to COVID-19
OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid COVID-19 antigen self testing and molecular sample collection for PCR-based tests. The Company’s portfolio of COVID-19 tests and collection kits all feature easy, convenient, pain-free self-collection, and help increase access to testing, while alleviating the burden on the healthcare system and minimizing exposure risks.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.
Important Information
This press release contains certain forward-looking statements, including with respect to products, product development activities, regulatory submissions and authorizations and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: risk that the Company's exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect operating results, business or investor perceptions; the diversion of management’s attention from the Company's ongoing business and regular business responsibilities due to the Company's exploration of strategic alternatives; ability to resolve the Company's ongoing manufacturing challenges and satisfy customer demand; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company's business and ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
| Investor Contact: | Media Contact: |
| Scott Gleason | Amy Koch |
| SVP Investor Relations & Corporate Communications | Sr. Mgr. Corporate Communications |
| 484-425-0588 | 484-523-1815 |
| sgleason@orasure.com | media@orasure.com |
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/836d2a58-cc8a-4e60-aad3-1764a2631dc5
FAQ
What is the significance of OraSure's FDA authorization for InteliSwab® tests in children?
What accuracy rates did the InteliSwab® tests achieve in the pediatric study?
What is the purpose of the InteliSwab® Connect app?
How well was the InteliSwab® test received by children?
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