Endometriosis as a
Systemic Disease
A molecular diagnostic development program grounded in scientific discipline, rigorous study design, and equity-embedded validation strategy.
Disease Framework and Scientific Approach
A chronic, systemic
inflammatory condition
Endometriosis is increasingly understood as a chronic, systemic inflammatory condition rather than a localized gynecologic disorder. Immune dysregulation, neuroimmune signaling, fibrosis, and hormone-responsive pathways extend beyond pelvic lesions and contribute to heterogeneous clinical presentations.
Despite this biological complexity, diagnosis still relies heavily on invasive procedures and delayed clinical confirmation. There remains a clear need for reproducible, biology-grounded molecular diagnostics that reflect the systemic nature of the disease.
Veridyn Diagnostics is focused on developing non-invasive molecular assays designed to meet that need.
Development
principles
Veridyn is a women's health diagnostics biotechnology company developing molecular assays, beginning with endometriosis as the first clinical indication.
The scientific strategy centers on identifying reproducible, disease-associated molecular patterns using non-invasive or minimally invasive specimen types compatible with routine clinical practice. Specimen selection prioritizes accessibility, stability, and integration within existing care pathways.
Development proceeds through defined stages of discovery, refinement, and validation, with strict separation between exploratory and confirmatory analyses.
Scientific discipline is embedded from the outset. Analytical design anticipates regulatory expectations, validation requirements, and downstream deployment constraints.
Emphasis is placed on
Reproducibility
Signal confirmation across independent sample sets before any panel commitment. Exploratory and confirmatory analyses are strictly separated.
Biological stability
Performance evaluated across demographic and biological variables. Key biological variables are addressed in study design.
Clinically meaningful thresholds
Specificity and sensitivity targets set to support clinical decision-making. Performance criteria are pre-specified and locked before analysis begins.
Technical robustness
Assay architecture designed for real-world laboratory conditions. Workflow complexity and infrastructure requirements evaluated against existing care settings.
Regulatory readiness
Data workflows and assay architecture structured to support clinical adoption without re-engineering at later stages. FDA pathway considered from day one.
Deployability
Integration into existing gynecologic and primary care interfaces considered early in development. The objective is not only analytical accuracy, but practical adoption within current clinical workflows.
Equity, Access, and Expansion
A technical parameter,
not a downstream initiative
Diagnostic delay in endometriosis reflects not only biological complexity, but variability in symptom recognition, referral patterns, and access to specialty evaluation. Studies have shown that time to diagnosis is influenced by socioeconomic context, insurance status, geographic access to care, and differences in how pelvic pain is evaluated across healthcare settings.
For a non-invasive molecular test to meaningfully improve outcomes, it must perform consistently across varied clinical and demographic contexts. Validation strategy therefore incorporates broad representation to assess signal stability, ensure generalizability, and reduce the risk of performance bias.
Cohort design, inclusion criteria, and performance evaluation are structured to support reliability across populations and care environments. Accessibility is similarly embedded in development decisions. Specimen strategy, workflow complexity, and cost considerations are evaluated with real-world adoption in mind.
A framework designed
to expand
Endometriosis is the initial clinical focus due to its systemic inflammatory profile, high prevalence, and prolonged diagnostic delay. It represents a condition in which non-invasive molecular discrimination could meaningfully alter clinical pathways.
The analytical architecture under development is designed to evaluate disease-associated molecular patterns within women's health more broadly. Upon demonstration of feasibility in endometriosis, additional gynecologic indications will enter the development pipeline.
Each indication will undergo its own staged validation process prior to clinical deployment. Expansion is structured, data-driven, and aligned with regulatory readiness.
The long-term objective is to deliver a portfolio of non-invasive molecular diagnostics across women's health using a cohesive, regulator-ready assay architecture.
Four-phase development
framework
Each phase has defined entry and exit criteria. Progression is contingent on pre-specified performance thresholds, not schedule. Results are published regardless of outcome.
Feasibility
Signal detection and specimen type selection. Rigorous molecular analysis. Go/no-go decision based on pre-specified pathway-level criteria.
Verification
Panel development on independent samples not used in Feasibility. Candidate markers validated by orthogonal method before panel commitment. Panel locked before Validation begins.
Validation
Prospective independent cohort enrolled through clinical partners. Performance evaluated at pre-specified sensitivity and specificity thresholds across all demographic groups.
Launch
CLIA-certified laboratory deployment. LDT available to ordering physicians. Regulatory submission for FDA clearance initiated. Results and methods published.
Pathway to
CLIA LDT launch
Three sequential milestones, each gated on the prior phase meeting its pre-specified performance criteria.
Feasibility cohort. Specimen type selection. First biomarker indications. Go/no-go at pathway level.
Independent verification cohort. Panel development and orthogonal confirmation. Diverse cohort representation.
CLIA certification. LDT available to ordering physicians. FDA pathway initiated. Results published.
Interested in collaborating?
Veridyn welcomes inquiry from clinicians, researchers, and institutions interested in specimen access, study design collaboration, or scientific partnership. Contact us to discuss how your work aligns with our development program.
- Clinical sample access
- Collaborative study design
- Scientific advisory
- Publication co-authorship
- Institutional partnership