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

 

Contact Our Custom Assay Development Team