InBios International
InBios is a leading biotechnology company based in Seattle, Washington, specializing in the design, development, and manufacture of immunodiagnostic devices for infectious diseases and biothreats. They focus on improving health outcomes globally by providing accurate, easy-to-use, and cost-effective diagnostic products. With over 25 years of experience, they have developed proprietary technologies, FDA-cleared kits, and respond rapidly to emerging infectious disease threats. Their products are manufactured in the USA, GMP compliant, FDA registered, USDA licensed, and ISO 13485:2016 certified.
Industries
Nr. of Employees
medium (51-250)
Products
Point-of-care rapid immunochromatographic test kits
Cassette/strip lateral flow test kits for qualitative detection of infectious agents or pathogen-specific antigens/antibodies, designed for whole blood or serum and for rapid field or clinic use.
ELISA kits for antibody detection
96-well ELISA plate kits for qualitative detection of pathogen-specific antibodies (IgG/IgM) and neutralizing antibody assays for serology and research use.
Analyte-specific reagents and conjugates
Catalog-supplied reagents such as HRP conjugates and pre-diluted conjugate preparations for assay development and laboratory use.
Point-of-care antigen detection kits for clinical and home use (where authorized)
Rapid antigen detection kits designed for decentralized testing environments, including formats intended for home-use authorization and clinical point-of-care testing.
Point-of-care rapid immunochromatographic test kits
Cassette/strip lateral flow test kits for qualitative detection of infectious agents or pathogen-specific antigens/antibodies, designed for whole blood or serum and for rapid field or clinic use.
ELISA kits for antibody detection
96-well ELISA plate kits for qualitative detection of pathogen-specific antibodies (IgG/IgM) and neutralizing antibody assays for serology and research use.
Analyte-specific reagents and conjugates
Catalog-supplied reagents such as HRP conjugates and pre-diluted conjugate preparations for assay development and laboratory use.
Point-of-care antigen detection kits for clinical and home use (where authorized)
Rapid antigen detection kits designed for decentralized testing environments, including formats intended for home-use authorization and clinical point-of-care testing.
Services
Contract manufacturing of diagnostic kits
Manufacture of rapid tests and ELISA kits under GMP in a US facility for commercial distribution or research use.
Custom assay development and turnkey program delivery
End-to-end assay development including feasibility, prototyping, analytical and stability studies, and preparation of regulatory design history files for submission.
Conjugate and reagent production
Custom production of conjugates (e.g., various-size gold particles, HRP conjugates) and supply of analyte-specific reagents for assay development and manufacture.
Regulatory and submission support
Guidance and preparation for regulatory filings including 510(k), PMA, EUA and CE marking activities.
Clinical trial management for diagnostic evaluation
Operational management and coordination of clinical studies to evaluate diagnostic performance, including studies used for regulatory submissions.
Contract manufacturing of diagnostic kits
Manufacture of rapid tests and ELISA kits under GMP in a US facility for commercial distribution or research use.
Custom assay development and turnkey program delivery
End-to-end assay development including feasibility, prototyping, analytical and stability studies, and preparation of regulatory design history files for submission.
Conjugate and reagent production
Custom production of conjugates (e.g., various-size gold particles, HRP conjugates) and supply of analyte-specific reagents for assay development and manufacture.
Regulatory and submission support
Guidance and preparation for regulatory filings including 510(k), PMA, EUA and CE marking activities.
Clinical trial management for diagnostic evaluation
Operational management and coordination of clinical studies to evaluate diagnostic performance, including studies used for regulatory submissions.
Expertise Areas
- Immunodiagnostics for infectious disease
- Lateral flow assay development and manufacturing
- ELISA development and diagnostic kit manufacturing
- Analytical validation and assay performance testing
Key Technologies
- Lateral flow immunoassay (LFIA) / immunochromatographic strip formats
- Enzyme-linked immunosorbent assay (ELISA)
- Gold nanoparticle conjugation
- Horseradish peroxidase (HRP) conjugation