Custom Assay Development Services
Assay development solutions tailored to your needs
When commercial off-the-shelf (COTS) products are not enough, trust InBios to develop a solution that will provide the quality results you require. InBios offers a range of custom development services including bioassays for agent identification, process development and basic research. Our team of molecular biologists and assay developers will work with you to deliver an immunodiagnostic solution that provides the quality results you expect.
Available Services:
- Feasibility studies
Production of conjugates, including various size gold particles
Prototype & beta test development
Full FDA compliance – design plan & design history files prepared
Laboratory studies – accelerated stability, cross-reactivity, interference, precision
Analytical sensitivity & specificity studies
Clinical trial management
FDA product submissions [510(k) & PMA]
Full turnkey option available: feasibility study to FDA submission
Expert regulatory guidance on all design & manufacturing issues
Small & large scale manufacturing of rapid & ELISA based immunoassays
