Research
Methods in context.
Limits in view.
Immunotyping Assist is a research prototype. Its manuscript is in preparation and has not been submitted. Research performance and cohort details are not disclosed.
Current research focus
Founder-provided development work studies narrow-peak subtraction features, κ/λ asymmetry, logistic regression, and batch-relative percentile thresholds.
The emphasis is human-review triage and reagent-lot or calibration drift, rather than autonomous diagnosis.
Evidence boundaries
- Single-center, retrospective development.
- Issued reports as the reference standard; blinded independent dual-reader reassessment pending.
- Systematic limitations for weak bands.
- Gamma-region detection offset; gamma percentage excluded from decisions.
- External validation, prospective workflow performance, and clinical utility remain pending.
Before broader use
The proposed next steps are blinded reassessment, clearly separated development and validation, multi-center evaluation, documented data and software rights, and TFDA classification consultation based on the intended use.
No cleared-device status, research acceptance, or clinical outcome benefit is claimed.
View the proposed development sequence