Todd Chermak, Senior Vice President & Global Business Head Immunology & Proteomics at CellCarta, discussed CDx models and the tools developed within CellCarta to classify several assays and the requirements for validation and regulatory measures needed for the clinical trials process, all the way through to a companion diagnostic.
In his presentation, Chermak presented some practical learnings from the FDA and IVDR. He began by introducing a framework for companion diagnostics. Next, he presented a single site model as a viable alternative for rare diseases or small patient populations, which is faster and less expensive.
The team at CellCarta adopts an exploratory and unified approach to companion diagnostics to determine their value and whether they could be taken to the market. Chermak emphasised the importance of having a unified system across the company to support diagnostic development, including design control and regulatory submissions.
More recently, the company has developed a hybrid model, where assays are explored for their potential as companion diagnostics before full investment. The key advantage of the hybrid model is that it can help de-risk a scientific portfolio when uncertain about the number of assays one can take forward in the value proposition as a companion diagnostic.
Following this, Chermak covered the importance of a unified quality system and the necessary regulatory deliverables for companion diagnostics. He also mentioned the use of master control to integrate quality pieces and the need for design control and regulatory submissions. The FDA and IVDR submission processes are typically lengthy and complicated because there are many criteria for risk determination and documentation required for IVDR submission processes.
Finally, the final rule by FDA was discussed, which ends the era of enforcement discretion for LDTs in the US. Chermak went on to explain the implications of this rule and the importance of having compliant quality systems to continue developing and launching assays. Overall, CellCarta’s submission activity over the past two years has taught the company the necessity of understanding regulatory nuances and individual country requirements and adapting their work and ways of thinking to suit these.
