ACCESS BIO, INC.

ACCESS BIO, INC. specializes in the manufacturing of in-vitro diagnostic substances, with a demonstrated focus on over-the-counter (OTC) infectious disease testing platforms, including rapid antigen tests for COVID-19. The company leverages proprietary immunoassay technologies to produce reliable, point-of-care diagnostic kits that meet regulatory standards for home and non-laboratory use. Their technical expertise lies in assay development, reagent formulation, lateral flow device integration, and quality-controlled production of diagnostic reagents compliant with FDA and CLIA guidelines. Key differentiators include scalable manufacturing processes tailored for high-volume OTC deployment and stringent control over batch consistency and shelf-life stability in consumer-facing diagnostic products. The contractor has delivered diagnostic solutions to the Department of Health and Human Services, primarily supporting public health emergency response initiatives through the supply of self-administered diagnostic tests. This relationship reflects a strategic alignment with federal efforts to expand decentralized testing capacity and enhance community-level surveillance infrastructure. ACCESS BIO, INC. operates within NAICS 325413, which encompasses the production of diagnostic reagents and substances used in clinical and consumer health settings. The company’s market positioning centers on the consumer diagnostics segment, particularly in rapid infectious disease detection, distinguishing itself through direct-to-consumer product design and regulatory pathways for non-prescription medical devices. As a privately held entity headquartered in Somerset, New Jersey, ACCESS BIO, INC. is structured as a small business (2L) with no active federal certifications. Its operational footprint is focused on domestic manufacturing and supply chain logistics to support federal health procurement requirements, positioning it as a specialized contributor to the U.S. diagnostic supply ecosystem.