I7*
SeveriDx™ Prediction Kit
Prof. Stanislav Kmoch, 1st Faculty of Medicine, Charles University; Dr Lenka Piherová, 1st Faculty of Medicine, Charles University; Dr Hana Hartmannová , 1st Faculty of Medicine, Charles University; Dr Michal Pohludka, SeveriDx s.r.o.; Dr Katerina Solcova, SeveriDx s.r.o.
GeneSpector s.r.o.
Challenge
Respiratory infections vary in severity—from mild symptoms to acute organ failure requiring intensive care. Current clinical practice lacks tools to reliably predict which patients will progress to severe disease, resulting in delayed recognition and higher mortality. This gap was highlighted during the COVID-19 pandemic, which overwhelmed healthcare systems and delayed care. SeveriDx s.r.o. addresses this need by developing the patent-protected SeveriDx Prediction Kit, a prognostic diagnostic test that predicts the severity of respiratory disease before full clinical symptom onset. Unlike conventional PCR panels that identify pathogens, this test measures the host’s immune response by quantifying serum amyloid A1 (SAA1) expression in the nasopharynx—a biomarker of acute inflammation.
Technology
SAA1 is a validated biomarker of infection severity with faster dynamics and higher sensitivity than CRP or PCT. It is upregulated in both bacterial and viral infections. The SeveriDx Prediction Kit detects a localized increase in SAA1 mRNA in nasopharyngeal samples—before systemic inflammation becomes measurable in blood. The assay uses a patented RT-qPCR method to quantify SAA1 mRNA in nasal epithelial cells, normalized to a reference gene, producing a ΔCt value that reflects local inflammation. Higher normalized expression indicates elevated risk of severe disease progression. The assay is compatible with standard qPCR systems, delivers results within clinically relevant timeframes, and integrates into existing diagnostic workflows. All IP rights are held by SeveriDx.
Commercial Opportunity
The global respiratory diagnostics market (~$7.2B annually) is driven by the high prevalence of respiratory infections and demand for improved risk stratification. SeveriDx addresses this need with early severity prediction for hospitals, ERs, clinics, and primary care.
Use cases include:
• ER triage – guiding ICU admission vs. discharge decisions
• Primary care – flagging high-risk patients for monitoring
• Inpatient settings – assessing treatment response within 8 hours The B2B commercialization strategy involves licensing or acquisition partnerships with major diagnostics companies to scale globally.
Development Status
The test is at Technology Readiness Level 4, with a functional prototype developed under ISO 13485 design control. Clinical study validation testing is upcoming, and analytical validation is ongoing to optimize performance. Regulatory roadmap: CE-IVDR certification targeted in Europe and FDA submission planned by 2028.
Patent Situation
A Czech patent (CZ309154) covering the assay method is granted, with protection through 2041. GeneSpector owns the patent and will grant SeveriDx exclusive licensing rights. International patent applications were filed in key markets (EU, US, Canada, Asia, Australia) for global coverage through 2041. Freedom-to-operate analysis is underway. A SeveriDx™ trademark is being secured, and proprietary manufacturing processes are protected as trade secrets.
Further Reading
• Czech Patent CZ309154 – Method for detecting SAA1 mRNA from nasopharyngeal swabs
• Pitch Deck – Includes development timeline, market sizing, and IP overview (on request)
• (Website launching in February)
