OraSure Technologies, Inc. Receives $7.5 Million Award for Development of Rapid Antigen Test for Marburg Virus Disease

OraSure Technologies received a $7.5 million contract to develop a rapid antigen test for Marburg Virus Disease.

Quiver AI Summary

OraSure Technologies, Inc. announced it received a $7.5 million award through the Rapid Response Partnership Vehicle to develop a rapid antigen test for Marburg Virus Disease (MVD). This funding, which could reach up to $11 million, is aimed at obtaining FDA 510(k) clearance for a lateral flow immunoassay designed to detect antigens in individuals at risk of MVD. OraSure's CEO, Carrie Eglinton Manner, emphasized the importance of this test for containing future outbreaks of the virus, which has a high fatality rate. The company aims to collaborate with BARDA, building on previous partnerships, and is committed to addressing global public health challenges through innovative diagnostic solutions.

Potential Positives

• OraSure Technologies received a significant contract award through the Rapid Response Partnership Vehicle (RRPV) valued at approximately $7.5 million, with potential increases up to $11 million, highlighting strong governmental support for its innovative diagnostic solutions.
• The development of a rapid antigen test for the Marburg Virus Disease addresses a critical global public health challenge, positioning OraSure Technologies as a key player in emerging infectious disease management.
• The company’s previous successful collaboration with BARDA in developing the InteliSwab® COVID-19 Rapid Test indicates a proven track record in partnering on significant health initiatives, enhancing its credibility and market position.

Potential Negatives

• The press release indicates a reliance on federal funding for product development, which could be vulnerable to shifts in government priorities or budget allocations.
• There is potential exposure to regulatory challenges, as achieving FDA 510(k) clearance is required and may not be guaranteed.
• The company acknowledges multiple risks related to its ability to meet customer demand and regulatory requirements, which could impact future performance and financial stability.

FAQ

What is the Marburg Virus Disease rapid antigen test?

The test is a lateral flow immunoassay for detecting antigens from the Marburg virus in at-risk individuals.

How much funding did OraSure receive for this project?

OraSure received approximately $7.5 million, with potential total funding up to $11 million over multiple years.

What is the purpose of the Marburg Virus test?

The test aims to help contain future Marburg virus outbreaks by rapidly detecting infections in symptomatic individuals.

Who partnered with OraSure for the test development?

OraSure is partnering with the Biomedical Advanced Research and Development Authority (BARDA) for this project.

What expertise does OraSure have in diagnostic tests?

OraSure is a leader in point-of-care and home diagnostic tests, previously developing tests for COVID-19 and Ebola.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$OSUR Hedge Fund Activity

We have seen 83 institutional investors add shares of $OSUR stock to their portfolio, and 161 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• AMERICAN CAPITAL MANAGEMENT INC removed 939,467 shares (-78.9%) from their portfolio in Q3 2024
• GOLDMAN SACHS GROUP INC removed 568,792 shares (-52.5%) from their portfolio in Q3 2024
• ACADIAN ASSET MANAGEMENT LLC added 523,276 shares (+23.8%) to their portfolio in Q3 2024
• ARROWSTREET CAPITAL, LIMITED PARTNERSHIP removed 385,190 shares (-100.0%) from their portfolio in Q2 2024
• ACUITAS INVESTMENTS, LLC added 353,897 shares (+inf%) to their portfolio in Q3 2024
• ARCHON CAPITAL MANAGEMENT LLC added 337,743 shares (+inf%) to their portfolio in Q3 2024
• NEUBERGER BERMAN GROUP LLC added 315,492 shares (+8.7%) to their portfolio in Q3 2024

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

BETHLEHEM, Pa., Dec. 02, 2024 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests and sample management solutions, today announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) for the development of a Marburg Virus Disease (MVD) rapid antigen test. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

The initial contract award, valued at approximately $7.5 million over multiple years in the base period with potential value up to $11 million, funds the development to achieve U.S. Food and Drug Administration (FDA) 510(k) clearance of a single-use lateral flow immunoassay intended for the qualitative detection of antigens from viruses within the Marburg virus genus. We expect that the proposed test will be intended for use with specimens from individuals with epidemiological risk factors who have signs or symptoms of MVD or from recently deceased individuals with epidemiological risk factors who are suspected to have died of MVD.

“A test with this utility has the potential to be an important tool in the containment of future Marburg virus outbreaks, and we are proud to partner with BARDA to develop it, helping to prevent the spread of this deadly virus, which has the capacity to cause outbreaks with a fatality rate similar to Ebola,” said Carrie Eglinton Manner, President and Chief Executive Officer of OraSure. “At OTI, we remain committed to partnering with government agencies to develop such tests that help address global public health challenges.”

OraSure has previously collaborated with BARDA in the development of the InteliSwab

^®

COVID-19 Rapid Test and maintains an ongoing partnership focused on enhancements to its 510(k) cleared point-of-care OraQuick

^®

Ebola Rapid Antigen Test.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.

About OraSure Technologies



OraSure Technologies, Inc. (“OraSure”) transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. OraSure, together with its wholly owned subsidiary, DNA Genotek Inc., is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, commercial entities, and direct to consumers. For more information on OraSure Technologies, please visit

www.orasure.com

.

Forward-Looking Statement



This press release contains certain forward-looking statements. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: our ability to satisfy customer demand; ability to reduce our spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to achieve the anticipated cost savings as a result of our business restructuring, including from insourcing third party manufacturing and exiting microbiome services; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on OraSure's business, supply chain, labor force, ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing, and demand for our COVID-19 testing products; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for OraSure’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of OraSure to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of OraSure’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity breaches or other attacks involving our systems or those of our third-party contractors and IT service providers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including inflationary pressures and banking stability. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.