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, Inc. (NASDAQ: OSUR) announced an amendment to the Emergency Use Authorization (EUA) for its InteliSwab™ COVID-19 rapid tests. The FDA now requires only one test for symptomatic individuals, simplifying the testing process. Previously, the test required two tests for both symptomatic and asymptomatic individuals. Additionally, studies confirmed that the InteliSwab™ tests can detect all COVID-19 variants of concern, including the Delta variant. This adjustment aims to increase the availability and accessibility of rapid testing across the nation.
OraSure Technologies (NASDAQ: OSUR) will hold its earnings conference call to discuss the third quarter financial results on November 3, 2021, at 5:00 PM ET. The financial results press release will be distributed at 4:01 PM ET. Interested parties can join the call by dialing (888) 771-4371 domestically or (847) 585-4405 internationally, using Conference ID # 50214426. A webcast will be available on the Investor Relations page of OraSure's website, and a replay will be accessible for 14 days after the call.
OraSure Technologies has secured a $109 million contract from the U.S. Department of Defense to enhance production capacity for its InteliSwab™ COVID-19 rapid tests. This initiative aims to bolster the nation’s pandemic preparedness, expanding manufacturing by 100 million tests annually by March 2024. The InteliSwab test, which detects active COVID-19 infections, has received multiple Emergency Use Authorizations from the FDA. The contract supports domestic industrial expansion for critical medical resources.
OraSure Technologies (NASDAQ: OSUR) has secured up to $13.6 million in funding from the Biomedical Advanced Research Development Authority (BARDA) to obtain 510(k) clearance and CLIA waiver for its InteliSwab™ COVID-19 rapid test. This test allows self-collection and provides results within 30 minutes without the need for lab equipment. The company holds three Emergency Use Authorizations (EUAs) from the FDA for different uses of the test, which is crucial for COVID-19 containment strategies. Full regulatory clearance is anticipated to ensure the test's long-term availability.
OraSure Technologies (NASDAQ: OSUR) announced a $205 million procurement contract with the Defense Logistics Agency for the InteliSwab™ COVID-19 Rapid Test, aimed at over-the-counter use. This contract will supply tests to approximately 25,000 U.S. sites from October 2021 to September 2022, funded by the federal government. InteliSwab™ offers a simple self-collection method and provides results in 30 minutes without the need for instruments. The company anticipates significant manufacturing and operating expenses related to this contract and expects the majority of revenue to be recognized in 2022.
OraSure Technologies (NASDAQ: OSUR) announced CFO Roberto Cuca will resign effective September 17, 2021, to pursue another healthcare opportunity. The company is seeking a permanent CFO, evaluating both internal and external candidates. Scott Gleason, SVP of Investor Relations and Corporate Communications, will serve as interim CFO. CEO Stephen Tang expressed confidence in the company’s outlook, citing increased demand for its InteliSwab™ COVID-19 Rapid Test and the recovery of core businesses.
OraSure Technologies announced strong financial performance for Q2 2021, with net revenues of $57.6 million, a 97% increase YoY. Excluding COVID-19 product sales, revenues grew 122% YoY, signaling a return to pre-pandemic levels. The company received FDA Emergency Use Authorizations for its InteliSwab™ COVID-19 Rapid Tests and signed distribution agreements with two major U.S. distributors. With cash reserves of $229.4 million, the company anticipates third-quarter revenues between $45 million and $50 million, projecting total revenues of approximately $230 million for FY 2021.
OraSure Technologies (NASDAQ: OSUR) is set to release its 2021 second quarter financial results on August 3, 2021, at 4:01 p.m. ET. The company will host a conference call at 5:00 p.m. ET to discuss these results and significant business developments.
Participants can join the call by dialing (888) 771-4371 for domestic access or (847) 585-4405 internationally, using Conference ID #50205303. The live Webcast will be accessible on OraSure's Investor Relations page, with a replay available for 14 days post-call.
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in diagnostic tests and specimen collection devices, announced Dr. Stephen S. Tang's participation in the Raymond James 2021 Human Health Innovation Conference. Scheduled for June 23, 2021, at 11:20 AM EDT, the event will be webcast live, accessible via OraSure Technologies' website. A replay will also be available for 14 days. OraSure is committed to enhancing health and wellness with its innovative diagnostic solutions offered globally across various healthcare sectors.
OraSure Technologies collaborates with the Will Rodgers Liver Health Foundation to raise awareness about Hepatitis C (HCV) in the U.S. Approximately 2.4 million Americans have HCV, with over half unaware of their infection. The partnership aims to promote testing, as untreated HCV can lead to severe liver conditions. The OraQuick® HCV rapid antibody test, offering results in 20 minutes, is central to the initiative. This effort aligns with the foundation's mission to educate and support communities affected by liver disease, enhancing early diagnosis and treatment access.
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