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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 reported a record revenue of $116.5 million for Q3 2022, marking a 116% increase from the previous year. The revenue from its InteliSwab testing increased to $79.6 million, a sequential growth of 85%. The company achieved a GAAP EPS of $0.07 and a non-GAAP EPS of $0.13. Positive cash flow from operations reached $16.3 million, ahead of guidance. Recent contracts have increased product visibility, including sales on Amazon. The company also secured an $8.6 million contract to develop a second-generation Ebola test.
OraSure Technologies (NASDAQ: OSUR) has received U.S. FDA clearance for its ORAcollect®•Dx saliva collection device for over-the-counter use, previously approved only for prescription. This device will be marketed alongside therapeutics for screening alpha1-antitrypsin deficiency (alpha-1) through a partnership with Grifols. Approximately 3% of COPD patients are estimated to be at risk for alpha-1. The AlphaID™ At Home Genetic Health Risk Service will be launched by Grifols in Q2 2023, utilizing the ORAcollect®•Dx to identify at-risk individuals.
OraSure Technologies (NASDAQ: OSUR) has launched its InteliSwab® COVID-19 Rapid Test on Amazon, enhancing access to testing for U.S. consumers. The product, which is easy to use and requires no additional equipment, will be sold and fulfilled by Amazon with free Prime shipping. CEO Carrie Eglinton Manner emphasized that this partnership aims to broaden consumer reach and increase product awareness. The InteliSwab® test has received Emergency Use Authorization from the FDA for over-the-counter use, further supporting its use in nationwide testing initiatives.
OraSure Technologies schedules its earnings conference call for the third quarter of 2022 on November 8, 2022, at 5:00 pm ET. The press release detailing the financial results will be available at 4:05 pm ET on the same day. Participants can register for the call through a provided link, and a live webcast will be accessible via the company's investor relations page. For those who cannot attend, the call will be archived for 14 days. This event will provide insights into the company's financial performance and developments.
OraSure Technologies (NASDAQ: OSUR) has secured an $8.6 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop a second-generation Ebola test utilizing the OraQuick® testing platform. The new test aims to enhance sensitivity, shelf life, and automation compared to the existing FDA-authorized version. OraSure's current Ebola Rapid Antigen Test is the only one with de novo FDA authorization since 2019 and has been widely used in Africa. This partnership underscores OraSure's commitment to addressing critical public health challenges.
OraSure Technologies (NASDAQ: OSUR) has been selected to provide OraQuick® In-Home HIV tests as part of the CDC’s ‘Together Take Me Home’ program, receiving $41.5 million over five years for community testing. The initiative targets populations disproportionately affected by HIV, aiming to deliver up to one million self-tests. This effort addresses barriers to HIV testing, such as privacy concerns and stigma, while empowering individuals to manage their health. The program is managed by Emory University in collaboration with various organizations.
OraSure Technologies (NASDAQ: OSUR) has announced a collaboration between its subsidiary Diversigen and Mars Petcare, aimed at enhancing understanding of pet health through microbiome research. This partnership involves sequencing microbiome samples from various breeds of cats and dogs as part of the Mars Petcare Biobank™ project. The collaboration aims to generate insights into microbial community composition to improve feline and canine health.
OraSure Technologies reported a strong financial performance for Q2 2022, with net revenues reaching $80.2 million, up 39% year-over-year, driven by a 213% increase in its Diagnostics business unit. InteliSwab® revenue surged to $43.1 million, representing 95% sequential growth. However, GAAP gross margins fell to 34.4%, down from 53.2% a year earlier. The company expects positive cash flow in Q4 2022, alongside strategic changes including a new CFO and Board adjustments.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its earnings conference call scheduled for August 9, 2022, at 5:00 p.m. ET, to discuss the second quarter financial results and business developments. A press release detailing the financial results will be distributed at 4:05 p.m. ET, followed by the conference call at 5:00 p.m. Participants can join the call by dialing (866) 374-5140 using conference ID #11565698. A webcast of the call will also be available on the investor relations page of OraSure's website.
OraSure Technologies (OSUR) reaffirms its commitment to combat Hepatitis C through the Race to End Hep C initiative, which offers free testing at select NASCAR events. This initiative uses the OraQuick® HCV Rapid Antibody Test, providing results in 20 minutes. In 2021, 2.5% of 351 tested individuals were linked to care after a positive result. The CDC reports around 2.4 million adults in the U.S. have HCV, with 40% unaware of their infection. The program aims to improve awareness and access to treatment, aligning with World Hepatitis Day.