OraSure Technologies Inc
NASDAQ:OSUR
OraSure Technologies Inc
OraSure Technologies, Inc. engages in the development, manufacture, and distribution of point of care diagnostic tests and molecular collection devices designed to detect or diagnose critical medical conditions. The company is headquartered in Bethlehem, Pennsylvania and currently employs 785 full-time employees. The firm's products include molecular sampling kits for the genome and microbiome services and analytics, rapid diagnostics for infectious disease, and tests for substance abuse. OraSure’s segments include Diagnostics segment and Molecular Collection Systems segment. The Diagnostics business primarily consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices. The Molecular Solutions business consists of the manufacture and sale of kits that are used to collect, stabilize, transport and store biological samples of genetic material for molecular testing in the consumer genetic, clinical genetic, academic research, infectious disease diagnostics, pharmacogenomics, personalized medicine, microbiome and animal genetics markets.
OraSure Technologies, Inc. engages in the development, manufacture, and distribution of point of care diagnostic tests and molecular collection devices designed to detect or diagnose critical medical conditions. The company is headquartered in Bethlehem, Pennsylvania and currently employs 785 full-time employees. The firm's products include molecular sampling kits for the genome and microbiome services and analytics, rapid diagnostics for infectious disease, and tests for substance abuse. OraSure’s segments include Diagnostics segment and Molecular Collection Systems segment. The Diagnostics business primarily consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices. The Molecular Solutions business consists of the manufacture and sale of kits that are used to collect, stabilize, transport and store biological samples of genetic material for molecular testing in the consumer genetic, clinical genetic, academic research, infectious disease diagnostics, pharmacogenomics, personalized medicine, microbiome and animal genetics markets.
Total Revenue: OraSure reported Q3 revenue of $27.1 million, with core revenue at $27 million.
Segment Performance: Diagnostics revenue was $14.5 million and Sample Management revenue was $10.3 million in Q3.
Guidance Update: Full-year 2025 International Diagnostics revenue is expected to decline about 20% year-over-year, while U.S. Diagnostics is projected to see a low single-digit decline.
Gross Margin: Q3 gross margin was 43.5%, slightly above expectations due to lower scrap expenses.
Innovation Pipeline: Company continues to invest in internal R&D and new product launches, with upcoming FDA submissions for novel diagnostic devices.
M&A Activity: OraSure signed an agreement to acquire BioMedomics, aiming to expand its international diagnostic offerings, especially in sickle cell disease.
Cash & Capital Deployment: Ended Q3 with $216 million in cash and no debt, and repurchased $5 million in shares during the quarter.
Outlook: Management characterizes 2025 as a transition year with a focus on returning to growth in 2026.