OraSure Technologies (OSUR) Submits COVID-19 Rapid Antigen Prescription Home Self-Test and Professional Test to FDA for Emergency Use Authorization

March 30, 2021 7:01 AM EDT

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OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its COVID-19 rapid antigen test for both Prescription Home Use, and Professional Use in point of care (POC) settings.

These lateral flow, rapid diagnostic tests are designed to detect active COVID-19 infection with a simple, easy-to-use workflow, using samples self-collected from the lower nostrils. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution. No instrumentation, batteries, smart phone or laboratory analysis is needed to read the result, which appears on the test stick a short time later.

“We believe our rapid antigen tests will be well received in the market thanks to their simplicity and ease of use. We also have the proven experience and capabilities to manufacture at scale to meet demand. With the race between vaccines and variants ongoing, testing will continue to play a crucial role in reopening workplaces, schools and other places where people gather,” said Stephen Tang, Ph.D., President and CEO of OraSure Technologies. “I’m delighted that we were able to accelerate the submission of the Prescription Home Self-Test. At-home testing will make it easier for individuals to safely and quickly know if they are infectious, and self-isolate to minimize transmission.”

Subject to receipt of Emergency Use Authorization, the Company intends to market a COVID-19 Prescription Home Self-Test and a Professional Test for use in POC settings. With a simple design and straightforward workflow, OraSure’s tests are well suited for use by individuals at home, as well as by health care providers, employers, pharmacies, universities, and deployment into underserved communities when prescribed by a healthcare provider.

ManufacturingOraSure has started manufacturing the COVID-19 rapid antigen test in parallel with EUA submission. The Company has well-established manufacturing capabilities, having produced over 80 million rapid HIV, HCV and Ebola tests. OraSure is in the midst of a manufacturing capacity expansion that will bring annual capacity for its rapid tests from 55 million tests at the end of the first quarter to 70 million tests beginning in the third quarter of 2021, and further to 120 million units per year by the second quarter of 2022. Included in these numbers are approximately 17 million of the Company’s existing tests for HIV, HCV and Ebola.

OraSure’s Response to the COVID-19 Pandemic OraSure is leveraging its expertise in infectious disease testing and molecular sample collection to advance COVID-19 testing and sample collection solutions across three modalities: Molecular/PCR, Antibody and Antigen. The Company’s portfolio of COVID-19 tests and collection kits all feature convenient, pain-free self-collection, and help increase access to testing, alleviate the burden on the healthcare system, minimize exposure risks and conserve personal protective equipment (PPE).

About OraSure TechnologiesOraSure 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.



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