Companion Diagnostics

Flagship’s industry leading science and technology is applied to the most challenging tissue interpretation needs. Our quantitative and contextual tissue scoring approaches provide robust and accurate results.

Your Partner from Concept to CDx

Exploratory endpoints for clinical trials are developed and validated in our GCP laboratory, and can be transitioned to CLIA validated biomarker selection approaches in our CLIA laboratory for patient selection hypothesis testing or PMA registration trials. Flagship’s proprietary tools and laboratory infrastructure are designed to create the high complexity, quantitative, in situ assay needed for targeted therapy and immuno-oncology patient selection approaches. Our in house quality assurance for clinical trials, regulatory affairs, and FDA Quality Manufacturing groups ensure that the image analysis approaches we create for the exploratory setting can be successfully transitioned into companion diagnostic devices.

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

From Proof of Concept to Medical Device

Success in your biomarker efforts leads to diagnostic development.

Flagship’s image analysis approaches require only common hardware (autostainers, whole slide scanners) found in clinical laboratories. Integration of our technology into existing IHC based CDx formats requires only the addition of our software, which includes the tissue interpretation method, design controls, and user interface.

To enable device registration trials and software manufacturing, Flagship has created a Quality Management System (QMS) for the development of medical device software in compliance with ISO13485, ISO14971, IEC62304 and FDA 21 CFR Part 820 QSR to enable us to enter into co-development agreements with IVD manufacturers to create image analysis based companion diagnostics. Our in-house CLIA laboratory supports the IVD registration trials required to commercialize the medical device.

Recent Posters

Our technology enables us to create custom image analysis approaches for even the most difficult pathology endpoints. Our software is developed through our experience in real world applications, supported by an internal research and development team, and is backed by our intellectual property portfolio.

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.