Welcome to our dedicated page for Orasure Tech news (Ticker: OSUR), a resource for investors and traders seeking the latest updates and insights on Orasure Tech stock.
OraSure Technologies, Inc. (NASDAQ: OSUR) is a medical devices company focused on point-of-need and home diagnostic tests and sample management solutions. The OraSure news stream on this page highlights company announcements, financial updates, product milestones, governance changes, and shareholder developments that shape the OSUR investment story.
News coverage commonly includes quarterly and year-to-date financial results, where OraSure reports net revenues, gross margins, operating performance, and the mix of diagnostics, sample management solutions, COVID-19 diagnostics, risk assessment testing, molecular services, and non-product revenues. Earnings releases also discuss core business trends, cash and cash equivalents, and share repurchase activity, providing context on the company’s financial condition and capital allocation.
Investors and industry followers can also track product and innovation milestones, such as FDA submissions for the Sherlock rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) and the Colli-Pee at-home urine collection device for sexually transmitted infections. Additional updates may cover launches of research-use products like HEMAcollect PROTEIN, agreements with partners such as GeneDx, and participation in initiatives like the ENDO1000 project.
Governance and corporate developments feature prominently in OraSure news. Recent items include board refreshment, the appointment of new independent directors, changes in board leadership, and the hiring of senior executives such as the Chief Commercial Officer. News also documents shareholder engagement, including communications from Altai Capital Management regarding board nominations and perspectives on company performance and strategy.
By following this OSUR news page, readers can review a chronological record of OraSure’s press releases and related items, covering earnings, product pipeline progress, strategic initiatives, board composition, and shareholder actions, all drawn from official company and partner announcements.
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.
OraSure Technologies, Inc. (NASDAQ: OSUR) is commemorating World AIDS Day on December 1st by ringing the NASDAQ closing bell in a virtual ceremony. CEO Stephen S. Tang emphasized the ongoing challenges posed by COVID-19 on HIV testing and treatment. The company is collaborating with the MTV Staying Alive Foundation on a video campaign and launching electronic vending machines for HIV self-test kits in Kenya. The OraQuick® HIV Self-Test remains a leader in rapid HIV diagnostics, with the first WHO-prequalified self-test in Sub-Saharan Africa.
OraSure Technologies (NASDAQ: OSUR) announced that Dr. Stephen S. Tang, President and CEO, will present at the Stephens Annual Investment Conference 2020 on November 19, 2020, at 8:00 AM EST. The event will be webcast live, allowing investors to tune in via OraSure’s website. A replay will be available for seven days post-event. OraSure Technologies specializes in point-of-care diagnostics and specimen collection, striving to enhance global health with innovative solutions.