The proprietary, high sensitivity Sanger sequencing assay (LOD <1%), developed by NeoGenomics, was used in certain BeiGene Phase 2 and Phase 3 clinical studies to determine the MYD88 status of patients with Waldenstroms Macroglobulinemia, during screening. For the past two years, our Pharma, Quality, and Regulatory teams has been hard at work developing the necessary quality systems, performing extensive analytical validation, and interacting with the FDA to develop the MYD88 assay as a single-site, FDA-approved test.
Though the MYD88 test was ultimately not required per the FDA, this project has paved the way for the necessary quality and laboratory infrastructure to better support CDx development within NeoGenomics. To say that there were many lessons learned during this project would be a massive understatement. These included:
- Building QMS on top of an existing CAP/CLIA quality system
- Sourcing of Waldenstrom’s samples to support validation. These samples are almost impossible to source commercially. Careful use of remnant samples and contrived samples (and negotiation with the FDA) was needed to support the analytical validation package
- Building infrastructure to support Day One Launch activities. Although we didn’t end up utilizing for this project, we have used this approach to good effect with some of our IVD partners.
- Building familiarity and rapport with the FDA review team.
Following this project, our team has a lot of great material to support at least a few white papers and presentations. Stay tuned for more on this topic.