NeoGenomics will share several posts focusing on CDx development. We will be launching an occasional updated blog covering our thoughts, musings, and opinions on personalized medicine.Or other topics that draw our fancy.
This new focus is driven by the large number of oncology clinical trials employing a personalized medicine strategy. We have a large menu of oncology biomarkers, frequently work with IVD partners on reproducibility studies, and do a significant amount customization and development for new biomarkers. The number of requests for CDx-grade projects as continued to increase year-over-year and we are continuing to build up laboratory capacity and internal expertise to handle increased demand.
A review of the list of FDA approved CDx demonstrates that most approvals have come through in the past 10 years. Whereas HER2 diagnostics (mostly ISH or IHC) dominate the list of approved markers through 2010, with the approval of BRAF and ALK diagnostics for vemurafenib and crizotinib in 2011, there has been an explosion of new CDx assays. Technologies now approved since Jan 2020 now include:
| Row Labels | Count of Technology |
|---|---|
| FISH | 5 |
| IHC | 12 |
| ISH | 2 |
| NGS | 5 |
| PCR | 14 |
| Sanger / PCR | 1 |
| Grand Total | 39 |
While not included in this list, we see multiplex IHC/IF, gene signatures (RNA counting) and flow cytometry as up-and-coming technologies for CDx development. NeoGenomics is building support infrastructure for all of these tools and technologies and we have some exciting projects in early phases of development.
We will be posting more in the coming weeks.
