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OraSure Technologies Inc. develops, manufactures and distributes point-of-need and home diagnostic tests, along with sample collection and stabilization products used in healthcare and research settings. Its portfolio includes rapid diagnostic tests and sample management solutions sold to clinical laboratories, hospitals, physicians' offices, clinics, public health and community organizations, research institutions, government agencies, pharmaceutical companies and consumers.
OraSure news commonly covers quarterly results, manufacturing efficiency, product regulatory updates, commercial launches, research and development priorities, and capital allocation. Company updates also address subsidiaries including DNA Genotek, Sherlock Biosciences and BioMedomics, products such as OraQuick HIV self-testing and Colli-Pee urine collection, and governance matters involving board composition and shareholder engagement.
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.
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.