Services

We define what must be proven, to whom, and with what evidence. We then design the studies, models, and reimbursement assets required to support coverage, payment, and pricing.

• Evidence strategy and target product profile: Translating disease epidemiology and etiology, intended use, target population, claims, comparators, and performance requirements into a sequenced evidence roadmap.
• Coverage landscape and payer evidence segmentation: Mapping coverage policies, benefit structures, decision-makers, and evidence thresholds by payer and line of business.
• Non-dilutive evidence funding: Funding strategy, opportunity identification, and proposal development across federal, foundation, and international sources.
  Product performance and validation: Claims-aligned analytical, clinical, and algorithmic validation, including biomarker selection, limit of detection, precision, sensitivity and specificity, reproducibility, and generalizability, where applicable.
• Clinical utility and decision-impact evidence: Prospective studies and vignette-based physician research measuring actionability, changes in clinical management, workflow integration, and downstream outcomes.
• Real-world and comparative evidence: EHR-, claims-, registry-, and cohort-based studies demonstrating performance in practice, comparative effectiveness, healthcare utilization, and patient outcomes.
• Health economics and financial modeling: Budget-impact, cost-effectiveness, return-on-investment, and total-cost-of-care models aligned with payer, ICER, and HTA expectations.
• Coding, coverage, and payment assets: CPT, PLA, and HCPCS strategy, technical assessment dossiers for MolDX/other MACs and commercial payer review, payment-pathway and rate-setting support, and medical-policy engagement.