CCI REAGENT's functional evaluation was conducted in accordance with EN 13612:2002 across multiple clinical reference laboratories. Below we summarise the key performance data and provide references for qualified partners.
Important: Performance data is provided with full study context and conditions. All numeric claims are referenced. Complete documentation — including study protocols, statistical methodology, and raw data summaries — is available on request under NDA.
Study reference: SSTR/ZYB/2021 — Functional evaluation per EN 13612:2002, manufacturer's technical file.
Study design: 8,078 urine samples across four reference cohorts (hospital-diagnosed cancer patients, patients with tyrosine-related disorders, patients with common diseases, and healthy controls). Three production lots tested across five clinical reference laboratories.
Key results: Sensitivity for the hospital-diagnosed cancer cohort: 96.69%. Specificity: 99.4%. Full statistical methodology and raw data summaries are available to qualified distributors under NDA.
Evaluation scope: Inter-lot reproducibility assessment across three independent production lots.
Methodology: Paired testing of identical sample sets across production lots, evaluated at five clinical reference laboratories under standardised conditions per EN 13612:2002.
Outcome: Consistent performance across all lots within acceptance criteria. Detailed lot comparison data is included in the full technical file, available under NDA.
Ongoing programme: IVDR post-market surveillance and performance follow-up as required under EU IVDR 2017/746.
Scope: Continuous collection of real-world performance data from European distribution partners. Trend analysis, complaint monitoring, and periodic safety update reporting.
Status: Active programme. European real-world performance data is being collected as part of the post-market surveillance plan. Updates are shared with distribution partners under the partnership framework.
Detailed clinical and performance documentation is available to qualified distributors and healthcare professionals. Request access through the distributor portal or contact our regulatory affairs team directly.
All performance claims on this website are presented with source, study context, and conditions. CCI REAGENT's clinical utility is supported by referenced data and is subject to ongoing post-market evaluation. Documentation available on request.
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