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) announced FDA authorization for its InteliSwab® COVID-19 rapid tests for children aged 2 to 14. The tests demonstrated an 85% positive percent agreement and 93% overall accuracy, highlighting their usability with a 96% success rate in administration by parents. The launch of InteliSwab® Connect reporting app was also announced to aid in COVID-19 prevalence tracking. These developments are significant for increasing testing access among children and supporting public health efforts.
OraSure Technologies (NASDAQ: OSUR) has launched its OraQuick® HIV Self-Test in Europe, expanding access to its in-home oral swab test for HIV-1 and HIV-2. Available in the UK, Germany, France, Italy, Spain, and Portugal, this CE-marked test requires no blood sample and offers results in just 20 minutes with over 99% accuracy. Since its U.S. debut in 2012, OraSure has distributed 76 million tests globally, focusing on areas with high HIV prevalence. The initiative aligns with increasing global testing policies and aims to enhance healthcare accessibility across Europe.
OraSure Technologies (NASDAQ: OSUR) announced that its InteliSwab® COVID-19 rapid tests effectively detect the Omicron variant as well as previous strains, including Delta and Alpha. Independent lab studies confirmed that the tests identified the Omicron variant at the same viral load as earlier variants. The tests are user-friendly, providing results in 30 minutes without the need for additional instruments. The InteliSwab® has received Emergency Use Authorization (EUA) from the FDA for over-the-counter and professional use. OraSure continues to adapt to evolving COVID-19 challenges.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its preliminary Q4 2021 financial outlook, expecting total revenue of approximately $60 million, with InteliSwab™ sales around $12 million. The Company is addressing technology transfer challenges to scale up production and capitalize on demand. A strategic review is underway to enhance shareholder value, coupled with leadership changes including CEO Stephen Tang's departure on March 31, 2022. The Board aims for improved operational performance and has appointed new presidents for Diagnostics and Molecular Solutions.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced that its 2022 Annual Meeting of Stockholders will take place on May 17, 2022, at 10:00 a.m. EDT, with a record date of March 27, 2022. The meeting will be conducted virtually via a live webcast, allowing only stockholders of record to vote. Additional details will be provided later. OraSure Technologies specializes in rapid diagnostic tests, sample collection, and molecular services, serving various sectors globally, including clinical laboratories and public health organizations.
OraSure Technologies (NASDAQ: OSUR) will ring the Nasdaq closing bell on November 30, 2021, to honor World AIDS Day.
The company has made significant advancements in HIV testing since the FDA approved its first rapid test in 2002, with over 70 million tests used worldwide.
The event will feature a panel discussing the history of the HIV epidemic. OraSure continues its commitment by supporting global HIV testing efforts.
CEO Stephen S. Tang emphasizes the need for continued action against the HIV epidemic, marking 40 years of progress.
OraSure Technologies announces participation in two upcoming conferences, with Dr. Stephen S. Tang, President and CEO, speaking at both. The first is the Stephens Annual Investment Conference on November 29, 2021, at 12:00 pm ET, followed by the Evercore 4th Annual HealthConx Virtual Conference on December 1, 2021, at 1:50 pm ET. Both events will be webcasted live. Interested parties can access the presentations and replays on the OraSure Technologies website for 14 days.
OraSure Technologies (NASDAQ: OSUR) announced the retirement of Jack E. Jerrett, Senior VP and General Counsel, after nearly 21 years. Effective December 31, 2021, he will be succeeded by Agnieszka M. Gallagher, previously Chief Ethics and Compliance Officer at Alnylam Pharmaceuticals. Gallagher brings over 20 years of legal and compliance experience, including roles at major companies like ViiV Healthcare and GSK Vaccines. OraSure aims to maintain its leadership in diagnostic testing and sample collection technologies with this transition.
OraSure Technologies has appointed Nancy J. Gagliano, M.D., and Anne C. Whitaker to its Board of Directors, effective November 8, 2021. Dr. Gagliano, a healthcare executive with a background in internal medicine and retail pharmacy, previously led the RADx Tech program at NIH during the COVID-19 pandemic. Her term expires at the 2024 Annual Meeting. Mrs. Whitaker, recognized as a leading figure in BioPharma, has over 30 years of pharmaceutical industry experience and will serve until the 2023 Annual Meeting. Both appointees bring extensive skills in global product development and public health, crucial for OraSure's growth strategy.
OraSure Technologies reported third quarter 2021 revenues of $53.9 million, a 12% year-over-year increase. Excluding COVID-19 products, revenues rose 37%. The company secured three major contracts totaling $327.6 million from U.S. government agencies for its InteliSwab™ COVID-19 Rapid Test. They revised revenue guidance for 2021 to between $230 million and $233 million. However, the gross margin fell to 39.8%, down from 63.1% a year ago, resulting in an operating loss of $13 million and a net loss of $15 million.
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