lateral flow assay development

AptAvian, Inc. is a biotechnology company formed in 2023 by two firms in aptamer production and airborne detection engineering to commercialize aptagenic technology platforms. It uses aptamers—single-strand DNA and RNA molecules with selective binding properties—to develop detection and therapeutic capabilities against airborne pathogens and biological threats. Over $3 million of R&D investment has produced multiple patents.

airborne pathogen detectionaptamer technologybioradar monitoringIVS (In Vivo Simulatum) testingtherapeutics development

Based in Austin, Texas, Attogene is a biotechnology and biomanufacturing company specializing in rapid detection technologies, assay development, environmental monitoring products, molecular biology tools, and custom assay solutions. It develops and manufactures lateral flow assays, ELISA kits, qPCR detection kits, qLAMP assays, enzymatic assays, nucleic acid products, and analytical testing platforms.

biomanufacturingcustom assay developmentELISA developmentenzymatic assaysnucleic acid testingPCR developmentqLAMP assays

Beacon Scientific is a lateral flow CDMO (Contract Development and Manufacturing Organization) specializing in lateral flow development and the creation of lateral flow assays (LFAs) for rapid, reliable, and cost-effective diagnostic solutions. The company offers IVD rapid prototyping, product development, and manufacturing, with decades of experience developing and commercializing medical devices. It operates under an ISO 13485:2016 Quality Management System and has developed products in oncology, veterinary medicine, chronic disease, infectious disease

3PL planningbiobankingbiomarker discovery and validationcassette engineeringcell culturingconjugation scale-upcustom surface chemistryELISAIVD manufacturingIVD product developmentIVD rapid prototypinglateral flow developmentLuminexlyophilizing reagentsMSDproject managementQMS integrationreagent formulationtech transfer management

BioSynchronicity Corporation is an SBA certified Woman Owned Small Business (WOSB) launched in June 2020 in the State of Washington. The company focuses on the design, development, research, validation, manufacturing, and commercialization of in vitro, clinical diagnostic, and forensic tests and devices for the health of humans, animals, and the ecosystem. Its flagship product, the C-Sync® COVID-19 Antigen Test, received FDA Emergency Use Authorization (EUA220346) in March 2023.

forensic testingmanufacturingpackaging customizationpoint of care testingquality assurancequality controlR&D

Bio-Val Consulting, LLC (BVC) is a woman-owned small business founded in 2013 by CEO Kristin H. Clement, Ph.D., dedicated to helping clients navigate assay development and validation and meet regulatory compliance for bioanalytical needs. It offers consulting on quantitative MOA-based bioassays supporting drug research and development, including antibody screening, characterization, potency and stability testing.

antibody purificationassay developmentassay validationbinding assayscAMP stimulation assayscell-based assaysddPCRECL (Meso Scale Discovery)ELISAELISpotFlow Cytometryneutralization assaysPCRphagocytosis assaysqPCRSDS-PAGE/Western Blot

Cactus Bio develops reagents and rapid tests to aid in the diagnosis of coccidioidomycosis (Valley Fever), with a mission to improve the speed and accuracy of testing. The company emerged from collaborative research by Dr. Douglas Lake at ASU and Dr. Thomas Grys at Mayo Clinic in Arizona, and is situated within the Health Futures Center (HFC). Its products are research and investigational use only.

antigen preparationdiagnostic test developmentimmunodiffusion reagent production

DCN Dx is an immunoassay CDMO and IVD CRO based in Carlsbad, CA. It provides contract development and manufacturing services, including lateral flow assay development, consumable and cassette design, custom readers, contract manufacturing, aseptic filling, and reagent lyophilization, along with clinical research services such as trial management, site development, biostatistics, data management, and regulatory consulting. Its 35,000+ sq. ft. facility is ISO 13485- and ISO 9001-compliant.

aseptic fillingbiospecimen collectionsbiostatisticsclinical trial managementconsumable and cassette designcontract manufacturingcustom reader designdata managementELISA developmentreagent lyophilizationRegulatory consulting