Computed by the pipeline on this desk · every number from this run’s state.json - nothing hand-edited.
enter Netherlands first: break-even Y2, trough €1.6M
Germany: break-even Y3, trough €-1.2M, end cash €24.4M
Netherlands: end cash €34.5M, minimum cash €1.6M
Netherlands: fundable · Germany: insolvent · Portugal: insolvent · Poland: insolvent
Netherlands → Germany → Portugal → Poland
The outline is fixed by the method; every number on it comes from this run.
Ranking with research applied: Netherlands → Germany → Portugal → Poland · closed-world: Netherlands → Germany → Portugal → Poland
Publicly available KBV/Zi and Versorgungsatlas publications distinguish iFOBT usage overall but do not provide separate national billing volumes for opportunistic (non‑programme) iFOBT, nor EBM‑code–level counts split by programme vs opportunistic use. Because the opportunistic component is explicitly not reported in national monitoring and only relative trends or overall utilisation are published, a quantitative estimate cannot be derived without direct access to underlying §295 SGB V billing data.
Zi-Trendreport 2023 Q4 – Kategorie "Bestimmung von okkultem Inanspruchnahme der Darmkrebsfrüherkennung in den Jahren 200KBV Praxisinformation Darmkrebsfrüherkennung – iFOBT, EBM-GODarmkrebsfrüherkennung: Versicherte nutzen Test dreimal häuf
Multiple independent clinical and policy analyses describe Guardant Health’s Shield blood-based colorectal cancer screening test—a key competitor—as having a list price of about $1,495 per test. CMS ADLT documentation and secondary analyses show Medicare reimbursement set at $1,495 from April 1, 2025, which aligns with the stated list price and functions as the effective public payer price in the U.S. market.
A Blood-Based Test for Colorectal Cancer ScreeningProjected Impact and Cost-Effectiveness of Novel Molecular BGuardant Health Receives ADLT Status From CMS for Shield BloAGA Clinical Practice Update on Current Role of Blood Tests
An MDCG notice summarising notified-body survey data states that time for assessment under the IVDR is estimated by notified bodies at up to 18 months, and a 2024 MedTech Europe manufacturer survey reports an average of roughly 18 months for IVDR QMS and technical documentation certification. Given ongoing capacity constraints and variability between notified bodies and product types (including class C assays), a working estimate of 18 months with a plausible range of 12–24 months from formal application to certificate is reasonable.
MDCG 2022-11 Rev.1 – Notice to manufacturers and notified boMedTech Europe 2024 Regulatory Survey – IVDR & MDR Survey Re
Population-based FIT programmes using stool tests as the main triage modality typically reach participation rates in the 50–70% range by the third organised screening round, with multiple European programmes showing rising or stable uptake at or above 60% over successive rounds. Using these FIT-based programmes as the closest analogue to a reimbursed colorectal-cancer triage assay suggests that a penetration benchmark of roughly half of the eligible volume within three years is conservative relative to observed practice, and substantially higher than one-fifth.
Colorectal cancer screening with faecal immunochemical test:Adherence to colorectal cancer screening: four rounds of faeImplementation of population screening for colorectal cancerImpact of delayed screening invitations on screen-detected a
APPLIED: web-sourced estimates entered the dataset as method SCOUT with their source URL; the engine re-ran on them. The closed-world ranking is kept alongside for comparison.
Evidence gaps: what the pack does not establish
Germany · Explicitly not centrally reported; excluded from the base case per the national report.
all · Competitor brief says 'broadly similar list price' - no number anywhere in the pack.
company · Single source (company briefing, 'expected within about a year'); no corroboration.
all · Ramp rests on ONE comparable pilot ('one fifth of eligible volume within three years').
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