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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 its InteliSwab® COVID-19 rapid tests effectively detect several Omicron subvariants, including BA.2, BA.3, and BA.5, on par with previous variants. This assessment was conducted by an independent lab using live SARS-CoV-2 virus, confirming reliable detection levels. InteliSwab® tests require minimal user involvement and offer results in about 30 minutes. The tests are FDA authorized for over-the-counter and professional use, enhancing accessibility for consumers and healthcare providers during the ongoing pandemic.
OraSure Technologies, Inc. (OSUR) reported a record Q1 2022 net revenue of $67.7 million, rising 16% year-over-year, driven by a 163% increase in Diagnostics revenue primarily from InteliSwab®, which generated $22.1 million in revenue, marking a 50% sequential gain. However, Molecular Solutions revenue declined 33% year-over-year, largely due to decreased COVID-19 kit sales. Operating loss totaled $16 million, influenced by production inefficiencies and strategic investments. The company has $112.2 million in cash as of March 31, 2022.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its earnings conference call for Q1 2022 results scheduled for May 10, 2022, at 5:00 pm ET. A press release detailing the financial results will be available at 4:01 pm ET on the same day. Interested participants can join the call by dialing (877) 344-8082 within the U.S. or (213) 992-4618 internationally, using Conference ID # 4956626. A webcast will also be accessible via OraSure’s Investor Relations page. An archived recording will be available for 14 days post-call.
OraSure Technologies, Inc. (NASDAQ: OSUR) has received de novo authorization from the FDA for its OMNIgene®·GUT Dx microbiome collection device, marking its commercial launch. This device facilitates the non-invasive collection and stabilization of human fecal samples for microbiome profiling. Kathleen Weber, President of Molecular Solutions, emphasized the importance of FDA authorization for advancing microbiome-related clinical assays and therapeutics. DNA Genotek, a subsidiary of OraSure, supports a global customer base in diagnostic testing, showcasing the device's widespread recognition in scientific research.
OraSure Technologies, Inc. (NASDAQ: OSUR) announced the launch of a new metatranscriptomic sequencing service through its subsidiary Diversigen, aimed at analyzing gut microbiome samples. This innovative service provides insights into gene expression and microbial functions, essential for understanding health issues and treatment impacts. The service utilizes advanced extraction methods and a comprehensive database of over 190,000 genomes. Target clients include researchers in pharmaceuticals, biotech, and academia, enhancing OraSure's portfolio in diagnostics and genomic research.
OraSure Technologies (NASDAQ: OSUR) has appointed Nancy Gagliano, MD, as interim CEO effective April 1, 2022, following the departure of Stephen Tang, Ph.D. Dr. Gagliano, who joined the Board in November 2021, brings extensive experience in diagnostics and healthcare, including leadership in the NIH’s RADx Tech program for COVID-19 testing. The Board is actively searching for a permanent CEO and continues to explore strategic alternatives to maximize stockholder value. The ongoing evaluation may or may not lead to conclusive transactions.
OraSure Technologies (NASDAQ: OSUR) reported a total revenue of $233.7 million for 2021, representing a 36% increase year-over-year. In Q4 alone, revenue reached $63.6 million, a 1% rise from Q4 2020. The InteliSwab® product saw significant growth, with Q4 revenues of $14.7 million, up 92% sequentially. However, the company faced challenges, including a net loss of ($10.4) million for Q4 and a 27% decline in Molecular Solutions revenues. Management is optimistic about InteliSwab®'s growth potential and plans for further scaling production.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its earnings conference call for the fourth quarter of 2021, scheduled for February 23, 2022, at 5:00 PM ET. A press release detailing the financial results will be distributed at 4:01 PM ET on the same day. Investors can participate by calling (888) 771-4371 domestically or (847) 585-4405 internationally, using Conference ID #50277718. The call will also be available via webcast on OraSure’s Investor Relations page, with a replay accessible for 14 days post-call.
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.