BARDA and OraSure Technologies, Inc. are partnering again, this time to advance their rapid antigen test for SARS-CoV-2 to U.S. Food and Drug Administration (FDA) 510(k) clearance.
BARDA supported development of the OraSure InteliSwab test from inception through Emergency Use Authorization (EUA) for over-the-counter (InteliSwab COVID-19 Rapid Test), prescription home use (InteliSwab COVID-19 Rapid Test Rx), and professional point-of-care use (InteliSwab COVID-19 Rapid Test Pro). These tests received EUA in June 2021. The 510(k) clearance and CLIA waiver for this test will ensure InteliSwab continues to be available on the market even after the public health emergency is declared over.
The test is a single-use lateral flow immunoassay with an integrated swab which helps to simplify the testing process and conserve limited diagnostic materials. InteliSwab’s simple workflow is designed for untrained lay users and yields quick results that appear on the test stick within minutes, without any need for instruments, batteries, a smartphone, or a full diagnostic laboratory. The InteliSwab test targets the detection of all clinically relevant SARS-CoV-2 variants of concern, as qualified by the U.S. Centers for Disease Control and Prevention (CDC). Currently there are no rapid point-of-care antigen tests available with 510(k) clearance.
Rapid COVID tests, whether used at home, at the point of care or in another location, are designed to provide quick and early diagnosis. By quickly identifying those who are infected with SARS-CoV-2, people can seek treatment earlier, which improves patient outcomes, and take precautions such as self-isolating to prevent spreading the virus to others. Rapid tests can be useful in supporting the safe reopening of schools, workplaces, and gathering places. Such tests may prove critical in those locations, by allowing people to promptly self-quarantine when necessary and reduce the risk of contagion.
About OraSure Technologies, Inc:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
OraSure Technologies, Inc., is based in Bethlehem, Pennsylvania. It receives funds from several agencies, including BARDA. The company develops, manufactures and markets point-of-care diagnostic products, oral fluid specimen collection devices, and laboratory diagnostic products. Products include rapid tests for the detection of COVID-19 antigens, for the detection of HIV and HCV antibodies; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse. OraSure products are sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research institutions, distributors, government agencies, physicians' offices, commercial and industrial entities, as well as direct to consumers. OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid 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.