Welcome to our dedicated page for OraSure Technologies news (Ticker: OSUR), a resource for investors and traders seeking the latest updates and insights on OraSure Technologies stock.
OraSure Technologies Inc., based in Bethlehem, Pennsylvania, is a pioneering medical devices company specializing in the development, manufacture, and distribution of oral fluid diagnostic and collection devices. As a leader in this field, OraSure offers a range of products designed to detect or diagnose critical medical conditions. The company operates through two primary segments: Diagnostics and Molecular Solutions.
In the Diagnostics segment, OraSure produces rapid oral diagnostic tests and specimen collection devices for infectious diseases, such as HIV and HCV. Notable products include the OraQuick® In-Home HIV Test, OraQuick Advance® Rapid HIV-1/2 Antibody Test, and the OraSure® HIV-1 Oral Specimen Collection Device. Additionally, the company offers the OraQuick® HCV Rapid Antibody Test, and various oral fluid testing solutions for drug abuse, such as the Intercept® Oral Fluid Drug Testing System and the Q.E.D.® Saliva Alcohol Test.
The Molecular Solutions segment focuses on kits used to collect, stabilize, and transport genetic material samples for molecular testing. These kits are essential for diagnosing hereditary diseases and infectious diseases, including COVID-19. The molecular solutions segment is a significant revenue driver for OraSure, with a substantial portion of sales originating from customers in the United States.
Beyond diagnostics, OraSure also manufactures and sells cryosurgical products like Histofreezer®, used for the cryosurgical removal of common and plantar warts, along with other benign skin lesions. These products are available both for professional physician office markets and over-the-counter use.
Recently, OraSure has announced its third-quarter 2023 financial results and certain business developments. Notably, the regular earnings conference call is scheduled for November 7, 2023. This announcement signifies the company's commitment to transparency and continuous communication with its stakeholders.
OraSure Technologies (NASDAQ: OSUR) will hold its earnings conference call to discuss the 2020 fourth quarter financial results on March 1, 2021, at 5:00 PM ET. A press release detailing the financial results will be distributed at 4:01 PM ET, followed by the call at 5:00 PM ET. Investors can access the call via phone or webcast on OraSure’s investor relations page. A replay will be available shortly after the call and for 14 days via the specified phone numbers. For queries, contact Sam Martin at Argot Partners.
OraSure Technologies (NASDAQ: OSUR) announced that its OMNIgene®·ORAL saliva collection kit received Emergency Use Authorization (EUA) from the FDA for use in COVID-19 testing by Ambry Genetics. This marks the eighth EUA involving a self-collection device from its subsidiary DNA Genotek. The kit allows for non-invasive saliva collection, enhancing testing accessibility and reducing exposure risks. Kathleen Weber, from DNA Genotek, expressed pride in this achievement, highlighting the increased access and safety offered by their self-collection devices.
OraSure Technologies, Inc. (NASDAQ: OSUR) announced that its OMNIgene®·ORAL (OME-505) saliva collection device has received authorization from Health Canada for use in molecular diagnostic tests to detect SARS-CoV-2. This approval allows broader accessibility for COVID-19 testing, including at-home self-collection. The device is non-invasive, easing the testing process compared to traditional methods. In addition, OMNIgene®·ORAL has Emergency Use Authorization from the FDA and CE marking for use in the EU.
OraSure Technologies (NASDAQ: OSUR) announced that Chronomics Limited has chosen its OMNIgene®·ORAL saliva collection device for use in a COVID-19 PCR test as part of the UK’s 'Test to Release for International Travel' program. This program allows travelers to shorten quarantine durations through negative test results. The OMNIgene®·ORAL device has FDA Emergency Use Authorization and is CE marked for the EU. The collaboration emphasizes DNA Genotek's position as a leading provider of saliva-based COVID-19 testing solutions.
OraSure Technologies (NASDAQ: OSUR) announced that its Oragene®•Dx (OGD-610) saliva collection device has been included in the FDA's De Novo authorization for Helix's Helix® Laboratory Platform, the first of its kind for whole exome sequencing. Additionally, it is part of the 510(k) clearance for Helix's Genetic Health Risk App for late-onset Alzheimer's Disease. This authorization allows Helix to develop further tests for various diseases, highlighting the value of OraSure's FDA-cleared device in genetic testing.
OraSure Technologies (NASDAQ: OSUR) has announced that its 2021 Annual Meeting of Stockholders is set for May 18, 2021, at 10:00 a.m. EDT. Stockholders must be on record by March 26, 2021, to participate. The meeting will be held virtually via a live webcast. Details regarding the meeting will be provided later. OraSure, along with its subsidiaries, focuses on providing health solutions and diagnostics for critical medical conditions globally.
On January 5, 2021, OraSure Technologies (NASDAQ: OSUR) announced that Dr. Stephen S. Tang, President and CEO, will present at the 39th Annual J.P. Morgan Healthcare Conference. His speech is scheduled for January 12, 2021, at 2:50 PM EST, and will be available via a live webcast on the company's website. A replay will also be accessible for 14 days post-event. OraSure Technologies specializes in point-of-care diagnostic tests and specimen collection devices, aiming to improve global health through comprehensive solutions.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced that its OMNIgene®·ORAL collection device is included in an FDA Emergency Use Authorization amendment granted to 3B BlackBio Biotech. This allows for expanded saliva COVID-19 testing across the U.S. The amendment enables qualitative detection of SARS-CoV-2 nucleic acid in saliva from individuals suspected of infection. This is the seventh EUA incorporating a product from OraSure’s DNA Genotek subsidiary, enhancing testing capabilities amid ongoing demand.
OraSure Technologies, Inc. (NASDAQ: OSUR) announced that the FDA requested additional information for its Emergency Use Authorization (EUA) application regarding its oral fluid SARS-CoV-2 antibody test. This test is unique as no oral fluid antibody tests have been authorized in the U.S. The company intends to resubmit the EUAs for the test and the collection device, along with additional analytical studies as requested. The quick and non-invasive oral sample collection method aims to enhance community surveillance for COVID-19.
OraSure Technologies, Inc. (NASDAQ: OSUR) announced that Dr. Stephen S. Tang, President and CEO, will present at the 2020 Evercore ISI HealthCONx Conference. The presentation is scheduled for December 3, 2020, at 9:40 AM EST. Investors can access the live webcast via OraSure's website. A replay will be available for 14 days post-event. OraSure is known for its point of care diagnostic tests and specimen collection solutions, serving various health and research sectors globally.
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