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OraSure Technologies, Inc. (NASDAQ: OSUR) is a medical devices company focused on point-of-need and home diagnostic tests and sample management solutions. According to company disclosures, OraSure (also referred to as "OTI") develops, manufactures, and distributes rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. The company operates in the surgical and medical instrument manufacturing industry within the broader manufacturing sector.

Based on the available information, OraSure’s business is organized around diagnostics and sample management solutions. Its diagnostics activities include rapid oral diagnostic tests and specimen collection devices for infectious diseases such as HIV and HCV, and COVID-19 diagnostics. The company also reports risk assessment testing and molecular services in its revenue breakdowns. Its sample management solutions business focuses on devices and kits used to collect, stabilize, and transport biological samples, including genetic material, for molecular testing of hereditary and infectious diseases.

Business model and revenue sources

OraSure generates revenue from net product and services sales in diagnostics, sample management solutions, COVID-19 diagnostics, risk assessment testing, and molecular services, as well as from non-product and services revenues. Company filings and earnings releases present revenues by category, including diagnostics, sample management solutions, other products and services, COVID-19 diagnostics, risk assessment testing, molecular services, and non-product and services revenues. These categories highlight the mix of recurring product sales and related activities that underpin the company’s business model.

In recent financial disclosures, OraSure has described a core business that includes diagnostics, sample management solutions, other products and services, and non-product and services revenues, excluding COVID-19, molecular services, and risk assessment testing. This distinction underscores the company’s emphasis on long-term diagnostic and sample management offerings beyond pandemic-related demand.

Diagnostics and point-of-need testing

OraSure describes itself as a leader in point-of-need and home diagnostic tests. Its portfolio includes rapid diagnostic tests designed to be used outside of centralized laboratories, enabling faster access to results. The company has highlighted HIV tests as a meaningful contributor within diagnostics, and has also reported COVID-19 diagnostics revenues. In its communications, OraSure emphasizes an approach to decentralizing diagnostics by connecting people to healthcare wherever they are, and by focusing on tests that are accessible, convenient, private, and personalized.

The company has announced development of a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). This test is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. It uses a self-collected swab and displays results directly on a hand-held testing device without the need for an electrical connection. OraSure has submitted this CT/NG self-test to the U.S. Food and Drug Administration (FDA) for review.

Sample collection and stabilization solutions

OraSure’s sample management solutions segment specializes in kits and devices used to collect, stabilize, and transport samples such as saliva, urine, blood, and other specimen types for downstream testing. Company disclosures reference products like ORAcollect kits, which support exome and genome analysis for rare pediatric diseases through a customer agreement with GeneDx. The firm also reports participation in initiatives such as the ENDO1000 project, a U.K.-wide effort using OraSure devices for collection and stabilization of saliva, urine, stool, and vaginal swab samples in research on endometriosis.

The company has also launched HEMAcollect PROTEIN, a blood collection product for research use aimed at proteomic discovery. According to OraSure, this product is intended to support extended protein stabilization and a simplified workflow for researchers, with the goal of operational and financial efficiencies and high-quality data generation in proteomics research.

Innovation roadmap and product development

OraSure frequently refers to its innovation roadmap across diagnostics and sample management solutions. Recent milestones include FDA submissions for the Sherlock rapid molecular self-test for CT/NG and the Colli-Pee at-home urine collection device for sexually transmitted infections (STIs). The Colli-Pee device is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. OraSure has indicated that the submission covers multiple STI indications and is being pursued in collaboration with a diagnostics platform provider. The company notes that clearance for these indications would be in addition to an existing research-use only version and could expand access to testing and strengthen its position in novel collection devices and chemistries.

OraSure has also reported a definitive agreement to acquire BioMedomics, adding SickleSCAN, a rapid, point-of-need test for sickle cell disease currently sold outside the U.S., to its diagnostic portfolio. The company has stated that it intends to leverage its international sales channels and relationships with national health programs to expand the reach and adoption of SickleSCAN.

Subsidiaries and organizational structure

OraSure conducts its business together with wholly owned subsidiaries including DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc. (following the referenced acquisition agreement). Through these entities, the company develops, manufactures, and distributes rapid diagnostic tests and sample collection and stabilization devices. These subsidiaries contribute to OraSure’s capabilities in genomics-focused sample collection, molecular diagnostics platforms, and specialized rapid tests.

Customer base and end markets

According to its public statements, OraSure sells its portfolio of products globally to a range of customers. These include clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct-to-consumer channels. The company has noted significant customer concentration in certain segments, such as consumer genomics, and has referenced specific relationships like its agreement with GeneDx and participation in government-funded programs.

OraSure has highlighted its role in programs such as the Together Take Me Home initiative, a collaboration funded by the U.S. federal government that distributes HIV self-tests by mail to reach at-risk populations. This illustrates how the company’s products are used in public health initiatives aimed at increasing testing access.

Strategic focus and operations

In its communications, OraSure emphasizes a strategy centered on decentralizing diagnostics, improving access, quality, and value of healthcare, and connecting people to care wherever they are. The company has described actions such as consolidating operations into its Pennsylvania footprint, insourcing manufacturing, and exiting unprofitable business lines to improve margins. It has also referenced maintaining a cash position with no debt and implementing a share repurchase program as part of its capital allocation approach.

OraSure reports ongoing efforts to advance its innovation roadmap, expand its diagnostics and sample management portfolio, and focus on high-growth opportunities with clear paths to commercialization and revenue realization. It has also mentioned initiatives to diversify its customer base, expand commercial reach, and strengthen its cost structure with the goal of sustainable profitability.

Corporate governance and shareholder engagement

OraSure’s board of directors has undergone notable refreshment in recent years. Company disclosures indicate that several directors have departed and new independent directors with healthcare, financial, and investor experience have joined the board. The board has appointed a new chair and added directors such as Steven K. Boyd, described as a seasoned investor with extensive experience in healthcare and medical device industries. The company has also highlighted the addition of a Chief Commercial Officer with extensive commercial leadership experience in diagnostics and lab services.

Recent news also documents engagement with a significant shareholder, Altai Capital Management, which has expressed concerns about share price performance and capital allocation and has nominated director candidates for election to the board. OraSure has responded by emphasizing its focus on shareholder value creation, its board’s independence and expertise, and its ongoing strategic initiatives.

Stock information and regulatory reporting

OraSure Technologies, Inc. trades on the NASDAQ under the ticker symbol OSUR. As a U.S. public company, it files periodic and current reports with the U.S. Securities and Exchange Commission (SEC), including Forms 10-K, 10-Q, and 8-K. Recent 8-K filings have covered quarterly financial results, investor presentations, and changes in the composition of the board of directors. These filings provide detailed information on the company’s financial condition, operating performance, and governance developments.

Risk factors and operating environment

In its forward-looking statements and risk disclosures, OraSure notes a range of factors that can affect its performance. These include the ability to satisfy customer demand, market and sell products, manage manufacturing and quality requirements, obtain regulatory approvals, respond to changes in public funding for health programs, navigate competition and technology changes, and manage customer concentration risk. The company also cites risks related to international operations, intellectual property, supply chains, cybersecurity, economic conditions, and other external factors. These risks are described in more detail in its SEC filings, such as its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Overall, OraSure Technologies, Inc. presents itself as a medical devices company focused on rapid diagnostics and sample management solutions, with an emphasis on decentralizing diagnostics and connecting people to healthcare in a more accessible and personalized way. Its operations span diagnostic tests, sample collection and stabilization, research-focused products, and participation in public health and research initiatives, supported by a portfolio of subsidiaries and a global customer base.