Companion Diagnostics

Flagship has the most advanced wet assay and quantitative analysis approaches in the industry designed for complex and quantitative in situ assays.

Your Partner from Concept to CDx

You can rely on us as a laboratory partner who is capable and experienced on all the major immunohistochemistry platforms. If you require a novel, quantitative approach for your companion diagnostic strategy, our proprietary and advanced image analysis technology is the most capable tool available to meet your demands. Flagship’s laboratories are specifically designed to create the high complexity, quantitative, in situ assay needed in your immune-oncology drug and medical device trials. Flagship is the ideal quantitative pathology partner when you need a flexible approach to CDx development which balances your clinical trial objectives and companion diagnostic needs.

Proven Success

We are very pleased to work with Flagship’s image analysis with mRNA ISH, which is particularly important for the development of companion diagnostics.

Dr. Xiao-Jun Ma, CSO of ACD

Flagship provides a continuous path to support our client’s CDx programs, from hypothesis testing approaches through IVD registration trials

Technology and Services for Early and Late CDx Efforts

Our approaches and technology are capable of delivering research and companion diagnostic (CDx) tools in areas where no other available approach exists. Our process allows us to turn exploratory methods into CLIA-compliant tests in order to support CDx development.

Work With Us

Our quality systems ensure the success of an approach from early small studies, through clinical trial evaluations, and into diagnostic assay development and approval.