Why Now: BH3 Mimetic Era Demands Functional Companion Diagnostics
Powerful but Heterogeneous Responses
BH3 mimetics and emerging MCL-1–targeted agents show powerful but variable responses in AML and MM, with rapid emergence of resistance limiting clinical utility
No Scalable Functional CDx
Current genomic and protein markers incompletely capture mitochondrial priming, leaving the pharmaceutical industry and clinicians without a scalable, functional companion diagnostic
Addressing Unmet Need
PRIMABS-Dx fulfills an industry-wide need for mechanistic, clinically applicable biomarkers that directly measure the target biology of BH3 mimetics
PRIMABS™-Dx Value Proposition
Final Common Pathway
Reads out mitochondrial priming—target of BH3 mimetics and convergence point for many targeted agents—rather than upstream genetics alone
Clinically Scalable Platform
Delivers assays compatible with standard clinical workflows that derisk trials, enrich responder populations, and enable real-time pharmacodynamic monitoring in routine patient samples.
Drug Development Integration
Accelerates companion diagnostic development timelines and regulatory pathways through mechanistically grounded, biologically validated biomarker algorithms tailored to specific agents.
For Drug Developers
Co-development of companion diagnostics for BH3 mimetics and targeted agents
Sponsored trials and CLIA testing revenue
Licensing of assays and algorithms
Future regulated IVDs
For Clinical Use
Stratification for venetoclax-based regimens in AML and MM