Commercial Use

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
  • Custom CLIA assay development with partners
  • Predictive reports for treatment selection
  • Pharmacodynamic monitoring