LDT USA first, with clinical evidence developed in parallel.
Our initial commercial objective is a centralized U.S. laboratory-developed test service, beginning with CultMed Test.
A centralized laboratory service
Under the planned model, participating clinics would send samples to a qualified CLIA-certified high-complexity laboratory for processing, sequencing, bioinformatics analysis, quality review and reporting.
Commercial introduction will depend on completion of the required validation and applicable laboratory and regulatory requirements. Success Test will follow its own evidence-based release decision.
Clinical Trial I · Health Canada
The current Clinical Trial I target is 100 samples.
The study is intended to build evidence on feasibility, sample handling and test performance. Clinical Trial I and the LDT validation program are related but distinct workstreams; the trial’s sample target does not by itself establish readiness for clinical use.
Longer-term development
Beyond the initial laboratory service, we plan to pursue international partnerships and an FDA development pathway for a distributed diagnostic platform.
Market by market
Expansion will depend on clinical evidence and the requirements of each market.
Explore clinic collaboration →