A ResearchDx company
Creating transformative diagnostic kits and reagents. CustomDx offers customized GMP manufacturing and kit development, including diagnostic, analytical and OEM assays, plus contract manufacturing for a variety of applications, in ISO 13485:2016 or GMP environments.
What CustomDx offers
CustomDx is organized into three divisions covering contract research, laboratory testing and diagnostic kit manufacturing.
Full CRO capabilities, biomarker discovery, assay development, regulatory filings and project management.
Assay commercialization, preclinical GLP services, clinical GCLP, CLIA testing and orthogonal validations, delivered through PacificDx.
ISO 13485 and GMP-compliant manufacturing, custom assay manufacturing, shipping kits and supplies, assay controls and materials, and pilot lots.
Quality
CustomDx works within the ResearchDx quality framework: CLIA certified, CAP accredited, FDA registered, GCLP compliant and ISO 13485 certified.
Your companion in diagnostics, from first assay to finished kit.
Tell us about your assay, components and volumes, and the CustomDx team will scope a development and manufacturing plan.