Post by Ivan Brukner

When a validated public laboratory-developed qPCR test can be performed for about CAD $10–14 per specimen, while the commercial IVD route costs about CAD $45, the policy question is no longer only technical. At 10,000 tests/year, that difference is roughly CAD $300,000–350,000. At 50,000 tests/year, it becomes more than CAD $1.5 million. This is not an argument against IVDs. Commercial IVDs are essential in many settings, especially for laboratories without development capacity. The issue is different: public healthcare systems should not become structurally dependent on proprietary IVD platforms when validated public LDT alternatives can provide clinically appropriate testing at lower cost, preserve local expertise, improve resilience, and protect taxpayer value. The responsible question is not “IVD or LDT?” The responsible question is: which validated testing model gives the best scientific, clinical, operational, and public-economic value? Illustrative source: Mahony et al., Journal of Clinical Microbiology, 2004; Ontario Laboratory Working Group for the Rapid Diagnosis of Emerging Infections. #LaboratoryDevelopedTests #LDT #IVD #InVitroDiagnostics #qPCR #RTPCR #MolecularDiagnostics #ClinicalLaboratory #PublicHealthcare #HealthcareEconomics #TaxpayerValue #DiagnosticStewardship #LaboratoryMedicine #PublicHealth #HealthPolicy #DiagnosticResilience #MedicalLaboratory #InnovationInHealthcare #ValueBasedHealthcare #PrecisionDiagnostics #Microbiology #InfectiousDiseases