Companion Diagnostics (CDx) play a significant role in drug development process by helping to stratify target patient population based on either efficacy or safety.
Successful and timely development of CDx is critical for rapid FDA clearance/approval and eventually go-to-market. Genosity offers unparalleled expertise in developing and executing CDx assay validation plans, participating in reproducibility studies (ILR) and providing real world feedback to technology manufacturers and sponsors in order to facilitate the commercialization of their product.
Genosity prides itself with expertise in clinical genomics, utmost quality of our services and great customer service. We work hand in hand with you to provide transparency in the process and ensure successful execution. Genosity can support the CDx and IVD development efforts by providing the following services
Genosity’s team can assist with running assays for exploratory research and analyze data to identify and select biomarkers that can assist in stratification of patient population.
With years of experience in developing and launching clinical genomic tests, our clinical and technical team can help with appropriate technology platform selection, panel design based on clinical evidence or research objectives, bioinformatics pipeline development and result report templates.
If the client has developed a custom assay in-house, and they need to transfer it and validate it in an outside lab, Genosity can transfer the assay and implement in our lab according to the client specifications. The technology transfer involves validating client’s assays to ensure the results are concordant between both labs, staff training, bioinformatic pipeline transfer or integration if needed, implementing SOPs, and relevant regulatory validation if desired. Genosity has been a strong partner to many assay developers who have a concept or prototype of a novel technology. Through years of operationalizing complex molecular assays, Genosity can assist in maturing an innovative assay for broad use while leveraging its proprietary IGT LIMS and Reporting software to overcome many of the operational challenges related to logistics and data management
Genosity can validate any assay with protocols, and replicate studies and sample numbers sufficient following appropriate regulatory guidelines . A more extensive validation can be performed for Clinical Trial Assay required to meet IDE requirements. We also offer bridging studies for IVD development in partnership with manufacturers pursuing FDA approval.
A dedicated Project Manager works hand in hand with the client to manage the project from initial requirement gathering to deliverable. Every project is assigned a study plan to make sure that project gets completed within the budget and on-time.
Genosity’s Gateway portal allows clients to track the status of samples from the moment they arrive at our laboratory.