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 (NASDAQ: OSUR) reported Q3 2020 revenues of $48.0 million, a 33% increase year-over-year, bolstered by $18.4 million in sales of oral fluid COVID-19 collection devices. The Molecular Solutions business unit achieved its highest revenue at $31.2 million, up 79% from last year. Despite growth, net income fell to $1.0 million or $0.01 per share, down from $13.1 million or $0.21 per share in Q3 2019. Fourth-quarter guidance anticipates net revenues between $55 million to $60 million.
OraSure Technologies announces that its subsidiary DNA Genotek received a second FDA Emergency Use Authorization (EUA) for the ORAcollect®·RNA saliva collection device. This device is authorized for at-home or healthcare setting use to collect saliva specimens suspected of containing SARS-CoV-2 RNA. The new EUA complements a previous authorization for the OMNIgene®·ORAL device. The company emphasizes the importance of non-invasive testing during the COVID-19 pandemic, stating that the collection method minimizes contact and PPE requirements.
OraSure Technologies, Inc. (NASDAQ: OSUR) will hold an earnings conference call on November 4, 2020, at 5:00 PM ET to discuss its third quarter financial results. A press release detailing the financial results will be issued at 4:01 PM ET on the same day. Participants can join the call by dialing 844-831-3030 (Domestic) or 315-625-6887 (International) with Conference ID # 9459222. The call will also be available via webcast on the company's Investor Relations page. A replay will be accessible for 14 days post-call.
OraSure Technologies (NASDAQ: OSUR) announced that its subsidiary DNA Genotek received Emergency Use Authorization (EUA) from the FDA for its OMNIgene®·ORAL saliva collection device for COVID-19 testing. This marks a significant milestone as it allows unsupervised at-home sample collection. The device has already been CE marked for use in the EU. The company is scaling up manufacturing to meet growing demand and has reported success in various testing programs across educational institutions and pharmacies. This development is crucial given the anticipated 2.4 billion annual tests needed in the U.S.
OraSure Technologies (NASDAQ: OSUR) announced that its ORAcollect®·RNA (OR-100) saliva collection device is included in the FDA Emergency Use Authorization for Quadrant Biosciences' COVID-19 test. This marks the sixth EUA for a collection device from OraSure’s DNA Genotek subsidiary, emphasizing its role in non-invasive COVID-19 testing. The Clarifi COVID-19 Test Kit, developed in collaboration with SUNY Upstate Medical University, will enable high-complexity labs to detect SARS-CoV-2. The device is crucial for increasing COVID-19 testing accessibility.
OraSure Technologies, Inc. (NASDAQ: OSUR) announced that Dr. Stephen S. Tang, President and CEO, will speak at two upcoming investor conferences. The first event is the Citi Spotlight on Diagnostics in a COVID-19 Environment on September 1, 2020, where Dr. Tang will participate in a panel at 12:05 PM EDT. The second is Baird’s 2020 Global Healthcare Conference on September 10, 2020, at 12:50 PM EDT. Investors can access the presentations via OraSure's website, with a replay available for 14 days.
OraSure Technologies, Inc. (NASDAQ: OSUR) reported a net revenue of $29.3 million for Q2 2020, down 25% from Q2 2019, with a net loss of $10.5 million, or $0.16 per share. The decline is attributed to lower sales across various products due to the COVID-19 pandemic, despite $8.5 million generated from oral fluid collection devices for COVID-19 testing. The company ended June 2020 with $265.8 million in cash, bolstered by an equity offering. Future product launches include a COVID-19 rapid antigen self-test and an ELISA-based antibody test expected in Q4 2020.
OraSure Technologies, Inc. (NASDAQ: OSUR) announced that its OMNIgene®·ORAL (OM-505) saliva collection device has received FDA Emergency Use Authorization (EUA) for COVID-19 testing, now included in Clinical Reference Laboratory's (CRL) CRL Rapid Response™ test. This marks the fourth EUA involving a device from OraSure's subsidiary, DNA Genotek. The OMNIgene·ORAL device allows for easier, self-collected saliva samples, improving safety and comfort compared to standard nasal swabs. The collaboration aims to enhance COVID-19 testing accessibility as businesses reopen.
OraSure Technologies (NASDAQ: OSUR) is set to host its 2020 second quarter earnings conference call on August 5, 2020, at 5:00 p.m. ET. The press release detailing the financial results will be distributed at 4:01 p.m. ET.
Participants can join the call by dialing 844-831-3030 (Domestic) or 315-625-6887 (International), using Conference ID #3276612. A live webcast will be available on the company's Investor Relations page.
OraSure Technologies (NASDAQ: OSUR) has launched the first commercially available device for in-home self-collection of fecal samples for metabolomics, named OMNImet™·GUT (ME-200). This device, developed by OraSure’s DNA Genotek subsidiary, aims to enhance the study of metabolites important for understanding human health and various diseases. The OMNImet™·GUT allows for sample stability at room temperature for up to seven days, facilitating ease of use for researchers. The product validates a growing trend toward multiomic approaches in life sciences, integrating various biological data for comprehensive health insights.