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"pattern": "eligible x participation / 2 (biennial)", "confidence": 1.0 }, "addressable_fit_positive": { "scope": "Portugal", "param": "addressable_fit_positive", "value": 40656, "unit": "persons", "source": "derived", "method": "INTERNAL", "pattern": "annual_screened x positivity", "confidence": 1.0 } }, "Germany": { "eligible_population": { "scope": "Germany", "param": "eligible_population", "value": 26400000, "unit": "persons", "source": "Germany/screening_report", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "participation": { "scope": "Germany", "param": "participation", "value": 0.22, "unit": "fraction", "source": "Germany/screening_report", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "fit_positivity": { "scope": "Germany", "param": "fit_positivity", "value": 0.06, "unit": "fraction", "source": "Germany/screening_report", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "price_per_test": { "scope": "Germany", "param": "price_per_test", "value": 235, 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}, "sensitivity": { "scope": "company", "param": "sensitivity", "value": 0.92, "unit": "fraction", "source": "company/company_briefing", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "specificity": { "scope": "company", "param": "specificity", "value": 0.54, "unit": "fraction", "source": "company/company_briefing", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "deferral_rate": { "scope": "company", "param": "deferral_rate", "value": 0.45, "unit": "fraction", "source": "company/company_briefing", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "penetration_benchmark": { "scope": "company", "param": "penetration_benchmark", "value": 0.2, "unit": "fraction", "source": "company/company_briefing", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "implied_prevalence": { "scope": "company", "param": "implied_prevalence", "value": 0.1957, "unit": "fraction", "source": "derived", "method": "INTERNAL", "pattern": "solved from sens/spec/deferral", "confidence": 1.0 }, "penetration_benchmark_web": { "scope": "company", "param": "penetration_benchmark_web", "value": 0.5, "unit": "fraction", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10877995/", "method": "SCOUT", "pattern": "GAP-04 \u00b7 Population-based FIT programmes using stool tests as the main triage modality typically re", "confidence": 0.5 } }, "competitor": { "onco_tests_per_year": { "scope": "competitor", "param": "onco_tests_per_year", "value": 300000, "unit": "tests", "source": "company/competitor_brief", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "onco_share_low": { "scope": "competitor", "param": "onco_share_low", "value": 0.35, "unit": "fraction", "source": "company/competitor_brief", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "onco_share_high": { "scope": "competitor", "param": "onco_share_high", "value": 0.4, "unit": "fraction", "source": "company/competitor_brief", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "onco_years_reimbursed": { "scope": "competitor", "param": "onco_years_reimbursed", "value": 3, "unit": "years", "source": "company/competitor_brief", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "list_price": { "scope": "competitor", "param": "list_price", "value": 1495, "unit": "EUR", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12795244/", "method": "SCOUT", "pattern": "GAP-02 \u00b7 Multiple independent clinical and policy analyses describe Guardant Health\u2019s Shield blood-", "confidence": 0.63 } }, "funding": { "grant_max": { "scope": "funding", "param": "grant_max", "value": 500000, "unit": "EUR", "source": "company/funding_call", "method": "DET", "pattern": "P1", "confidence": 1.0 }, "cofinance_rate": { "scope": "funding", "param": "cofinance_rate", "value": 0.6, "unit": "fraction", "source": "company/funding_call", "method": "DET", "pattern": "P1", "confidence": 1.0 } } }, "facilities": { "facilities": [ { "facility_uid": "HLX-GE-001", "country": "Germany", "institution": "Charite 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"master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-191", "country": "Portugal", "institution": "Clinica Endoscopica do Porto", "unit": 5, "type": "Endoscopy", "type_votes": "Endoscopy:9/Pathology:6", "type_conflict": true, "capacity_annual": 2650, "capacity_min": 1500.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 15, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-192", "country": "Portugal", "institution": "Clinica Endoscopica do Porto", "unit": 6, "type": "Endoscopy", "type_votes": "Endoscopy:14/Pathology:4", "type_conflict": true, "capacity_annual": 2900, "capacity_min": 850.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 18, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-193", "country": "Portugal", "institution": "Hospital CUF Descobertas", "unit": 1, "type": "Endoscopy", "type_votes": "Endoscopy:6/Pathology:1", 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"capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 13, "registers": "national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-215", "country": "Portugal", "institution": "Hospital de Braga", "unit": 5, "type": "Endoscopy", "type_votes": "Endoscopy:10/Pathology:2", "type_conflict": true, "capacity_annual": 3050, "capacity_min": 1500.0, "capacity_max": 4100.0, "capacity_conflict": true, "n_source_records": 12, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-216", "country": "Portugal", "institution": "Hospital de Braga", "unit": 6, "type": "Endoscopy", "type_votes": "Endoscopy:4", "type_conflict": false, "capacity_annual": 2325, "capacity_min": 850.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 4, "registers": "national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-217", "country": "Portugal", "institution": "Hospital de Santa Maria", "unit": 1, "type": "Endoscopy", 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"master_only": false }, { "facility_uid": "HLX-PO-220", "country": "Portugal", "institution": "Hospital de Santa Maria", "unit": 4, "type": "Endoscopy", "type_votes": "Endoscopy:14/Pathology:3", "type_conflict": true, "capacity_annual": 3800, "capacity_min": 2900.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 17, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-221", "country": "Portugal", "institution": "Hospital de Santa Maria", "unit": 5, "type": "Endoscopy", "type_votes": "Endoscopy:7/Pathology:4", "type_conflict": true, "capacity_annual": 2900, "capacity_min": 1500.0, "capacity_max": 3200.0, "capacity_conflict": true, "n_source_records": 11, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-222", "country": "Portugal", "institution": "Hospital de Santa Maria", "unit": 6, "type": "Endoscopy", "type_votes": "Endoscopy:8/Pathology:1", "type_conflict": true, "capacity_annual": 2200, "capacity_min": 850.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 9, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-223", "country": "Portugal", "institution": "IPO Porto", "unit": 1, "type": "Endoscopy", "type_votes": "Endoscopy:14/Pathology:2", "type_conflict": true, "capacity_annual": 2325, "capacity_min": 850.0, "capacity_max": 3800.0, "capacity_conflict": true, "n_source_records": 16, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-224", "country": "Portugal", "institution": "IPO Porto", "unit": 2, "type": "Endoscopy", "type_votes": "Endoscopy:5/Pathology:1", "type_conflict": true, "capacity_annual": 3800, "capacity_min": 850.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 6, "registers": "national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-225", "country": "Portugal", "institution": "IPO Porto", "unit": 3, "type": "Endoscopy", "type_votes": "Endoscopy:4/Pathology:3", "type_conflict": true, "capacity_annual": 2900, "capacity_min": 1750.0, "capacity_max": 3200.0, "capacity_conflict": true, "n_source_records": 7, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-226", "country": "Portugal", "institution": "IPO Porto", "unit": 4, "type": "Endoscopy", "type_votes": "Endoscopy:11/Pathology:2", "type_conflict": true, "capacity_annual": 2800, "capacity_min": 850.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 13, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-227", "country": "Portugal", "institution": "IPO Porto", "unit": 5, "type": "Endoscopy", "type_votes": "Endoscopy:13/Pathology:3", "type_conflict": true, "capacity_annual": 3200, "capacity_min": 850.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 16, "registers": "master+national:Portugal", "master_only": false }, { "facility_uid": "HLX-PO-228", "country": "Portugal", "institution": "IPO Porto", "unit": 6, "type": "Endoscopy", "type_votes": "Endoscopy:6/Pathology:5", "type_conflict": true, "capacity_annual": 4100, "capacity_min": 3200.0, "capacity_max": 5200.0, "capacity_conflict": true, "n_source_records": 11, "registers": "master+national:Portugal", "master_only": false } ], "summary": { "raw_records": 3236, "raw_by_country": { "Portugal": 716, "Germany": 1091, "Netherlands": 612, "Poland": 817 }, "unique_facilities": 228, "capacity_conflicts": 226, "type_conflicts": 208, "master_only": 0, "repairs": [ { "market": "Poland", "raw": { "id": "3604", "name": "Szpital Gdansk - Unit 6", "country": "PATH", "type": "", "capacity_annual": null }, "action": "repaired:no-country" }, { "market": "Poland", "raw": { "id": "3693 Szpital Kliniczny Warszawa - Unit 6", "name": "Poland", "country": "PATH", "type": "", "capacity_annual": "" }, "action": "repaired:left-shift" }, { "market": "Poland", "raw": { 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"company/market_landscape": 700 }, "agree": true }, { "scope": "Germany", "param": "eligible_population", "sources": { "Germany/screening_report": 26400000, "company/market_landscape": 26400000 }, "agree": true }, { "scope": "Germany", "param": "fit_positivity", "sources": { "Germany/screening_report": 0.06, "company/market_landscape": 0.06 }, "agree": true }, { "scope": "Germany", "param": "participation", "sources": { "Germany/screening_report": 0.22, "company/market_landscape": 0.22 }, "agree": true }, { "scope": "Germany", "param": "price_per_test", "sources": { "Germany/screening_report": 235, "company/market_landscape": 235 }, "agree": true }, { "scope": "Germany", "param": "time_to_reimbursement_months", "sources": { "Germany/screening_report": 24, "company/market_landscape": 24 }, "agree": true }, { "scope": "Netherlands", "param": "colonoscopy_tariff", "sources": { "Netherlands/screening_report": 650, "company/market_landscape": 650 }, "agree": true }, { "scope": "Netherlands", "param": "eligible_population", "sources": { "Netherlands/screening_report": 4950000, "company/market_landscape": 4950000 }, "agree": true }, { "scope": "Netherlands", "param": "fit_positivity", "sources": { "Netherlands/screening_report": 0.091, "company/market_landscape": 0.091 }, "agree": true }, { "scope": "Netherlands", "param": "participation", "sources": { "Netherlands/screening_report": 0.71, "company/market_landscape": 0.71 }, "agree": true }, { "scope": "Netherlands", "param": "price_per_test", "sources": { "Netherlands/screening_report": 215, "company/market_landscape": 215 }, "agree": true }, { "scope": "Netherlands", "param": "time_to_reimbursement_months", "sources": { "Netherlands/screening_report": 12, "company/market_landscape": 12 }, "agree": true }, { "scope": "Poland", "param": "colonoscopy_tariff", "sources": { "Poland/screening_report": 300, "company/market_landscape": 300 }, "agree": true }, { "scope": "Poland", "param": "eligible_population", "sources": { "Poland/screening_report": 11200000, "company/market_landscape": 11200000 }, "agree": true }, { "scope": "Poland", "param": "fit_positivity", "sources": { "Poland/screening_report": 0.065, "company/market_landscape": 0.065 }, "agree": true }, { "scope": "Poland", "param": "participation", "sources": { "Poland/screening_report": 0.17, "company/market_landscape": 0.17 }, "agree": true }, { "scope": "Poland", "param": "price_per_test", "sources": { "Poland/screening_report": 115, "company/market_landscape": 115 }, "agree": true }, { "scope": "Poland", "param": "time_to_reimbursement_months", "sources": { "Poland/screening_report": 12, "company/market_landscape": 12 }, "agree": true }, { "scope": "Portugal", "param": "colonoscopy_tariff", "sources": { "Portugal/screening_report": 400, "company/market_landscape": 400 }, "agree": true }, { "scope": "Portugal", "param": "eligible_population", "sources": { "Portugal/screening_report": 3050000, "company/market_landscape": 3050000 }, "agree": true }, { "scope": "Portugal", "param": "fit_positivity", "sources": { "Portugal/screening_report": 0.062, "company/market_landscape": 0.062 }, "agree": true }, { "scope": "Portugal", "param": "participation", "sources": { "Portugal/screening_report": 0.43, "company/market_landscape": 0.43 }, "agree": true }, { "scope": "Portugal", "param": "price_per_test", "sources": { "Portugal/screening_report": 155, "company/market_landscape": 155 }, "agree": true }, { "scope": "Portugal", "param": "time_to_reimbursement_months", "sources": { "Portugal/screening_report": 12, "company/market_landscape": 12 }, "agree": true } ], "findings": [ { "id": "CHK-01", "name": "Landscape vs national report agreement", "status": "PASS", "severity": "fail", "detail": "24 multi-source parameters compared; 0 disagreement(s)", "note": "Every parameter present in both the Market Landscape and a national screening report must agree (tolerance 0.5%).", "resolution": { "state": "", "how": "" } }, { "id": "CHK-02", "name": "Competitor volume vs addressable market", "status": "FAIL", "severity": "fail", "detail": "OncoStream claims 300,000 tests/yr but Germany's entire organised addressable volume is 174,240/yr (1.7x the whole market). Company-reported figure REJECTED for modelling; the independent 35-40% share estimate (~61-70k tests/yr) is retained instead.", "note": "A vendor cannot process more triage tests than the entire organised addressable volume. Company-reported figures must be checked against primary screening statistics.", "resolution": { "state": "handled", "how": "handled: the company-reported figure is excluded from the model; the independent share estimate is used" } }, { "id": "CHK-03", "name": "Competitor claim vs its own analyst share estimate", "status": "WARN", "severity": "warn", "detail": "fails for Germany", "note": "The 300k claim should also be consistent with the 35-40% independent share estimate quoted in the same brief.", "resolution": { "state": "handled", "how": "handled: same figure as CHK-02, excluded from the model" } }, { "id": "CHK-04", "name": "Rates are valid fractions", "status": "PASS", "severity": "fail", "detail": "0 out-of-range value(s)", "note": "", "resolution": { "state": "", "how": "" } }, { "id": "CHK-05", "name": "Deferral rate consistent with sensitivity/specificity", "status": "PASS", "severity": "warn", "detail": "holds for company", "note": "Deferred share = (1-sens)*prev + spec*(1-prev). Solving for the pack's 45% deferral implies ~20% significant-pathology prevalence among FIT-positives - internally consistent.", "resolution": { "state": "", "how": "" } }, { "id": "CHK-06", "name": "Facility capacity plausibility", "status": "PASS", "severity": "warn", "detail": "126 monthly rows annualised x12; 0 endoscopy unit(s) without resolvable capacity", "note": "Endoscopy units must report positive annual capacity after normalisation; pathology units carry none by design. Monthly-reported rows must have been annualised (x12).", "resolution": { "state": "", "how": "" } }, { "id": "CHK-07", "name": "Screened volume arithmetic", "status": "PASS", "severity": "fail", "detail": "holds for Portugal, Germany, Netherlands, Poland", "note": "Addressable = eligible x participation / 2 (biennial) x positivity, recomputed from components.", "resolution": { "state": "", "how": "" } }, { "id": "CHK-08", "name": "Colonoscopy demand vs national endoscopy capacity", "status": "INFO", "severity": "info", "detail": "Portugal: 40,656 referrals vs 165,425 register capacity (25% utilisation) | Germany: 174,240 referrals vs 156,433 register capacity (111% utilisation) | Netherlands: 159,910 referrals vs 155,800 register capacity (103% utilisation) | Poland: 61,880 referrals vs 145,125 register capacity (43% utilisation)", "note": "FIT-positive referrals compared with deduplicated national endoscopy capacity - a utilisation, not an error, check.", "resolution": { "state": "", "how": "" } }, { "id": "CHK-09", "name": "Absolute values inside plausible ranges", "status": "PASS", "severity": "fail", "detail": "0 out-of-range value(s)", "note": "A population read as \"11.5\" instead of 11,500,000, or a price read as 0.215, passes arithmetic checks that only compare derived numbers to their own components. This check catches the component itself.", "resolution": { "state": "", "how": "" } } ], "workspace": "exercise-one", "files": { "skipped": [ "0_Candidate_Brief.pdf" ], "unassigned": [] }, "conclusion": { "ranking": [ "Netherlands", "Germany", "Portugal", "Poland" ], "recommendation": "Netherlands", "results": { "Portugal": { "years": [ { "year": 1, "ramp": 0.0, "tests": 0, "cogs": 58.0, "revenue": 0, "gross_margin": 0, "ebitda": -2050000, "cash": 1830000 }, { "year": 2, "ramp": 0.17500000000000002, "tests": 7115, "cogs": 54.5, "revenue": 1102794, "gross_margin": 715037, "ebitda": -1334963, "cash": 495037 }, { "year": 3, "ramp": 0.325, "tests": 13213, "cogs": 51.0, "revenue": 2048046, "gross_margin": 1374173, "ebitda": -675827, "cash": -180790 }, { "year": 4, "ramp": 0.5, "tests": 20328, "cogs": 47.5, "revenue": 3150840, "gross_margin": 2185260, "ebitda": 135260, "cash": -45530 }, { "year": 5, "ramp": 0.55, "tests": 22361, "cogs": 44.0, "revenue": 3465924, "gross_margin": 2482049, "ebitda": 432049, "cash": 386519 } ], "break_even_year": 4, "min_cash": -180790, "end_cash": 386519, "insolvent": true, "offset_years": 1, "system_saving_per_100": 2500, "params": { "eligible_population": 3050000, "participation": 0.43, "fit_positivity": 0.062, "price_per_test": 155, "time_to_reimbursement_months": 12, "colonoscopy_tariff": 400, "screening_interval": "Biennial", "entry_cost": 120000, "inmarket_cost_per_year": 250000, "annual_screened": 655750, "addressable_fit_positive": 40656 } }, "Germany": { "years": [ { "year": 1, "ramp": 0.0, "tests": 0, "cogs": 58.0, "revenue": 0, "gross_margin": 0, "ebitda": -2400000, "cash": 1150000 }, { "year": 2, "ramp": 0.0, "tests": 0, "cogs": 54.5, "revenue": 0, "gross_margin": 0, "ebitda": -2400000, "cash": -1250000 }, { "year": 3, "ramp": 0.17500000000000002, "tests": 30492, "cogs": 51.0, "revenue": 7165620, "gross_margin": 5610528, "ebitda": 3210528, "cash": 1960528 }, { "year": 4, "ramp": 0.325, "tests": 56628, "cogs": 47.5, "revenue": 13307580, "gross_margin": 10617750, "ebitda": 8217750, "cash": 10178278 }, { "year": 5, "ramp": 0.5, "tests": 87120, "cogs": 44.0, "revenue": 20473200, "gross_margin": 16639920, "ebitda": 14239920, "cash": 24418198 } ], "break_even_year": 3, "min_cash": -1250000, "end_cash": 24418198, "insolvent": true, "offset_years": 2, "system_saving_per_100": 8000, "params": { "eligible_population": 26400000, "participation": 0.22, "fit_positivity": 0.06, "price_per_test": 235, "time_to_reimbursement_months": 24, "colonoscopy_tariff": 700, "screening_interval": "Biennial", "entry_cost": 450000, "inmarket_cost_per_year": 600000, "annual_screened": 2904000, "addressable_fit_positive": 174240 } }, "Netherlands": { "years": [ { "year": 1, "ramp": 0.0, "tests": 0, "cogs": 58.0, "revenue": 0, "gross_margin": 0, "ebitda": -2150000, "cash": 1650000 }, { "year": 2, "ramp": 0.17500000000000002, "tests": 27984, "cogs": 54.5, "revenue": 6016614, "gross_margin": 4491472, "ebitda": 2341472, "cash": 3991472 }, { "year": 3, "ramp": 0.325, "tests": 51971, "cogs": 51.0, "revenue": 11173711, "gross_margin": 8523203, "ebitda": 6373203, "cash": 10364675 }, { "year": 4, "ramp": 0.5, "tests": 79955, "cogs": 47.5, "revenue": 17190325, "gross_margin": 13392462, "ebitda": 11242462, "cash": 21607138 }, { "year": 5, "ramp": 0.55, "tests": 87950, "cogs": 44.0, "revenue": 18909358, "gross_margin": 15039536, "ebitda": 12889536, "cash": 34496673 } ], "break_even_year": 2, "min_cash": 1650000, "end_cash": 34496673, "insolvent": false, "offset_years": 1, "system_saving_per_100": 7750, "params": { "eligible_population": 4950000, "participation": 0.71, "fit_positivity": 0.091, "price_per_test": 215, "time_to_reimbursement_months": 12, "colonoscopy_tariff": 650, "screening_interval": "Biennial", "entry_cost": 200000, "inmarket_cost_per_year": 350000, "annual_screened": 1757250, "addressable_fit_positive": 159910 } }, "Poland": { "years": [ { "year": 1, "ramp": 0.0, "tests": 0, "cogs": 58.0, "revenue": 0, "gross_margin": 0, "ebitda": -2100000, "cash": 1750000 }, { "year": 2, "ramp": 0.17500000000000002, "tests": 10829, "cogs": 54.5, "revenue": 1245335, "gross_margin": 655155, "ebitda": -1444846, "cash": 305154 }, { "year": 3, "ramp": 0.325, "tests": 20111, "cogs": 51.0, "revenue": 2312765, "gross_margin": 1287104, "ebitda": -812896, "cash": -507742 }, { "year": 4, "ramp": 0.5, "tests": 30940, "cogs": 47.5, "revenue": 3558100, "gross_margin": 2088450, "ebitda": -11550, "cash": -519292 }, { "year": 5, "ramp": 0.55, "tests": 34034, "cogs": 44.0, "revenue": 3913910, "gross_margin": 2416414, "ebitda": 316414, "cash": -202878 } ], "break_even_year": 5, "min_cash": -519292, "end_cash": -202878, "insolvent": true, "offset_years": 1, "system_saving_per_100": 2000, "params": { "eligible_population": 11200000, "participation": 0.17, "fit_positivity": 0.065, "price_per_test": 115, "time_to_reimbursement_months": 12, "colonoscopy_tariff": 300, "screening_interval": "Biennial", "entry_cost": 150000, "inmarket_cost_per_year": 300000, "annual_screened": 952000, "addressable_fit_positive": 61880 } } }, "skipped": {} }, "gaps": [ { "id": "GAP-01", "market": "Germany", "field": "opportunistic testing volume", "why": "Explicitly not centrally reported; excluded from the base case per the national report.", "impact": "Upside only - could enlarge German addressable volume.", "plan": [ "Query: KBV/G-BA opportunistic FIT volume statistics", "Source type: statutory insurance billing data (EBM codes)", "Fills: Germany.opportunistic_volume (quarantined until human-approved)" ] }, { "id": "GAP-02", "market": "all", "field": "competitor list price", "why": "Competitor brief says 'broadly similar list price' - no number anywhere in the pack.", "impact": "Pricing pressure scenario in NL/PT/PL cannot be quantified.", "plan": [ "Query: OncoStream tender records, national procurement portals", "Source type: public tender award notices", "Fills: competitor.list_price per market (quarantined until human-approved)" ] }, { "id": "GAP-03", "market": "company", "field": "IVDR certification timeline", "why": "Single source (company briefing, 'expected within about a year'); no corroboration.", "impact": "A slip would not block CE-marked sales but matters for tenders.", "plan": [ "Query: notified-body queue times for IVDR class C assays", "Source type: MedTech Europe / notified body reports", "Fills: company.ivdr_expected_months (quarantined until human-approved)" ] }, { "id": "GAP-04", "market": "all", "field": "penetration benchmark", "why": "Ramp rests on ONE comparable pilot ('one fifth of eligible volume within three years').", "impact": "The single most sensitive model input; the \u00b150% ramp scenario brackets it.", "plan": [ "Query: published uptake curves for triage assays post-reimbursement", "Source type: peer-reviewed screening-programme evaluations", "Fills: company.penetration_benchmark corroboration (quarantined until human-approved)" ] } ], "manifest": { "run_at": 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"quote": "Among returned tests, 6.2 per cent are positive at the applied faecal haemoglobin threshold.", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Portugal", "param": "price_per_test", "det": 155, "llm": 155, "quote": "A national laboratory pathway can typically be established within about twelve months of application, and a reimbursed price in the order of EUR 155 per test is consistent with recent comparable decisions.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Portugal", "param": "time_to_reimbursement_months", "det": 12, "llm": 12, "quote": "A national laboratory pathway can typically be established within about twelve months of application, and a reimbursed price in the order of EUR 155 per test is consistent with recent comparable decisions.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Portugal", "param": "colonoscopy_tariff", "det": 400, "llm": 400, "quote": "Colonoscopy reimbursement tariff EUR 400", "confidence": 1.0, "verdict": "AGREE" }, { "scope": "Germany", "param": "eligible_population", "det": 26400000, "llm": 26400000, "quote": "The eligible population is approximately 26.4 million.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "participation", "det": 0.22, "llm": 0.22, "quote": "Participation in the organised offer is 22 per cent.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "fit_positivity", "det": 0.06, "llm": 0.06, "quote": "FIT positivity is 6.0 per cent.", "confidence": 1.0, "verdict": "AGREE" }, { "scope": "Germany", "param": "price_per_test", "det": 235, "llm": 235, "quote": "A reimbursed price of approximately EUR 235 per test is consistent with recent comparable inclusions.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "time_to_reimbursement_months", "det": 24, "llm": 24, "quote": "Recent decisions indicate an elapsed period of approximately twenty-four months between application and routine reimbursed volume.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "colonoscopy_tariff", "det": 700, "llm": 700, "quote": "Colonoscopy reimbursement tariff EUR 700", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "eligible_population", "det": 4950000, "llm": 4950000, "quote": "Eligible population (50\u201374) 4,950,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "participation", "det": 0.71, "llm": 0.71, "quote": "Programme participation 71%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "fit_positivity", "det": 0.091, "llm": 0.091, "quote": "FIT positivity rate 9.1%", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "price_per_test", "det": 215, "llm": 215, "quote": "A reimbursed price in the order of EUR 215 per test is consistent with recent comparable decisions.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "time_to_reimbursement_months", "det": 12, "llm": 12, "quote": "Decisions on inclusion of new laboratory tests are comparatively fast; a route to reimbursed volume within approximately twelve months is consistent with recent practice.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "colonoscopy_tariff", "det": 650, "llm": 650, "quote": "Colonoscopy reimbursement tariff EUR 650", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "eligible_population", "det": 11200000, "llm": 11200000, "quote": "Eligible population (50-74) | 11200000 | persons", "confidence": 1.0, "verdict": "AGREE" }, { "scope": "Poland", "param": "participation", "det": 0.17, "llm": 0.17, "quote": "Programme participation | 17% | of invited | (1)", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Poland", "param": "fit_positivity", "det": 0.065, "llm": 0.065, "quote": "FIT positivity rate | 6.5% | of returned tests", "confidence": 1.0, "verdict": "AGREE" }, { "scope": "Poland", "param": "price_per_test", "det": 115, "llm": 115, "quote": "Indicative reimbursed price, triage test | 115 | EUR | (2)", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "time_to_reimbursement_months", "det": 12, "llm": 12, "quote": "Time to reimbursed volume | 12 | months", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Poland", "param": "colonoscopy_tariff", "det": 300, "llm": 300, "quote": "Colonoscopy reimbursement tariff | 300 | EUR", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Portugal", "param": "eligible_population", "det": 3050000, "llm": 3050000, "quote": "Eligible population (50\u201374) 3,050,000 26,400,000 4,950,000 11,200,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "eligible_population", "det": 26400000, "llm": 26400000, "quote": "Eligible population (50\u201374) 3,050,000 26,400,000 4,950,000 11,200,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "eligible_population", "det": 4950000, "llm": 4950000, "quote": "Eligible population (50\u201374) 3,050,000 26,400,000 4,950,000 11,200,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "eligible_population", "det": 11200000, "llm": 11200000, "quote": "Eligible population (50\u201374) 3,050,000 26,400,000 4,950,000 11,200,000", "confidence": 1.0, "verdict": "AGREE" }, { "scope": "Portugal", "param": "participation", "det": 0.43, "llm": 0.43, "quote": "FIT programme participation 43% 22% 71% 17%", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Germany", "param": "participation", "det": 0.22, "llm": 0.22, "quote": "FIT programme participation 43% 22% 71% 17%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "participation", "det": 0.71, "llm": 0.71, "quote": "FIT programme participation 43% 22% 71% 17%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "participation", "det": 0.17, "llm": 0.17, "quote": "FIT programme participation 43% 22% 71% 17%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Portugal", "param": "fit_positivity", "det": 0.062, "llm": 0.062, "quote": "FIT positivity rate 6.2% 6.0% 9.1% 6.5%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "fit_positivity", "det": 0.06, "llm": 0.06, "quote": "FIT positivity rate 6.2% 6.0% 9.1% 6.5%", "confidence": 0.93, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "fit_positivity", "det": 0.091, "llm": 0.091, "quote": "FIT positivity rate 6.2% 6.0% 9.1% 6.5%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "fit_positivity", "det": 0.065, "llm": 0.065, "quote": "FIT positivity rate 6.2% 6.0% 9.1% 6.5%", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Portugal", "param": "price_per_test", "det": 155, "llm": 155, "quote": "Price per test EUR 155 EUR 235 EUR 215 EUR 115", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "price_per_test", "det": 235, "llm": 235, "quote": "Price per test EUR 155 EUR 235 EUR 215 EUR 115", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "price_per_test", "det": 215, "llm": 215, "quote": "Price per test EUR 155 EUR 235 EUR 215 EUR 115", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Poland", "param": "price_per_test", "det": 115, "llm": 115, "quote": "Price per test EUR 155 EUR 235 EUR 215 EUR 115", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Portugal", "param": "time_to_reimbursement_months", "det": 12, "llm": 12, "quote": "Time to reimbursed revenue ~12 months ~24 months ~12 months ~12 months", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "time_to_reimbursement_months", "det": 24, "llm": 24, "quote": "Germany's pathway is longer, on the order of two years.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "time_to_reimbursement_months", "det": 12, "llm": 12, "quote": "Time to reimbursed revenue ~12 months ~24 months ~12 months ~12 months", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "time_to_reimbursement_months", "det": 12, "llm": 12, "quote": "Time to reimbursed revenue ~12 months ~24 months ~12 months ~12 months", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Portugal", "param": "entry_cost", "det": 120000, "llm": 120000, "quote": "One-time entry cost 120,000 450,000 200,000 150,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "entry_cost", "det": 450000, "llm": 450000, "quote": "One-time entry cost 120,000 450,000 200,000 150,000", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "entry_cost", "det": 200000, "llm": 200000, "quote": "One-time entry cost 120,000 450,000 200,000 150,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "entry_cost", "det": 150000, "llm": 150000, "quote": "One-time entry cost 120,000 450,000 200,000 150,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Portugal", "param": "inmarket_cost_per_year", "det": 250000, "llm": 250000, "quote": "In-market cost per year 250,000 600,000 350,000 300,000", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Germany", "param": "inmarket_cost_per_year", "det": 600000, "llm": 600000, "quote": "In-market cost per year 250,000 600,000 350,000 300,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "inmarket_cost_per_year", "det": 350000, "llm": 350000, "quote": "In-market cost per year 250,000 600,000 350,000 300,000", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Poland", "param": "inmarket_cost_per_year", "det": 300000, "llm": 300000, "quote": "In-market cost per year 250,000 600,000 350,000 300,000", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Portugal", "param": "colonoscopy_tariff", "det": 400, "llm": 400, "quote": "Colonoscopy reimbursement EUR 400 EUR 700 EUR 650 EUR 300", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Germany", "param": "colonoscopy_tariff", "det": 700, "llm": 700, "quote": "Colonoscopy reimbursement EUR 400 EUR 700 EUR 650 EUR 300", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "Netherlands", "param": "colonoscopy_tariff", "det": 650, "llm": 650, "quote": "Colonoscopy reimbursement EUR 400 EUR 700 EUR 650 EUR 300", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "Poland", "param": "colonoscopy_tariff", "det": 300, "llm": 300, "quote": "Colonoscopy reimbursement EUR 400 EUR 700 EUR 650 EUR 300", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "company", "param": "cash_runway", "det": 4000000, "llm": 4000000, "quote": "Cash on hand (runway) EUR 4.0 million", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "company", "param": "corporate_cost_per_year", "det": 1800000.0, "llm": 1800000, "quote": "Corporate operating cost (HQ, R&D, G&A) EUR 1.8 million per year, approximately flat", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "company", "param": "cogs_year1", "det": 58, "llm": 58, "quote": "Cost of goods is approximately EUR 58 per test today, expected to fall with volume to approximately EUR 44 per test by the fifth year of commercial operation.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "company", "param": "cogs_year5", "det": 44, "llm": 44, "quote": "Cost of goods is approximately EUR 58 per test today, expected to fall with volume to approximately EUR 44 per test by the fifth year of commercial operation.", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "company", "param": "sensitivity", "det": 0.92, "llm": 0.92, "quote": "Against colonoscopy as the reference standard, the test achieved 92 percent sensitivity for significant pathology and 54 percent specificity.", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "company", "param": "specificity", "det": 0.54, "llm": 0.54, "quote": "Against colonoscopy as the reference standard, the test achieved 92 percent sensitivity for significant pathology and 54 percent specificity.", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "company", "param": "deferral_rate", "det": 0.45, "llm": 0.45, "quote": "At observed prevalence, this allows approximately 45 percent of FIT-positive patients to be safely deferred from immediate colonoscopy.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "company", "param": "penetration_benchmark", "det": 0.2, "llm": 0.2, "quote": "As a reference point, an earlier pilot of a comparable triage assay reached roughly one fifth of eligible FIT-positive volume within three years of reimbursement being in place.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "competitor", "param": "onco_tests_per_year", "det": 300000, "llm": 300000, "quote": "On the company's own account, its laboratory network now processes approximately 300,000 triage tests per year across German endoscopy and pathology partners, a figure management has cited in investor updates as evidence of near-saturation of the organised-screening channel.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "competitor", "param": "onco_share_low", "det": 0.35, "llm": 0.35, "quote": "Independent estimates place its share at 35\u201340% of addressable triage volume in Germany.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "competitor", "param": "onco_share_high", "det": 0.4, "llm": 0.4, "quote": "Independent estimates place its share at 35\u201340% of addressable triage volume in Germany.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "competitor", "param": "onco_years_reimbursed", "det": 3, "llm": 3, "quote": "Its assay, positioned after a positive faecal immunochemical test (FIT) and before colonoscopy referral, has been reimbursed in Germany for roughly three years and is entrenched with several of the largest endoscopy networks.", "confidence": 0.9, "verdict": "AGREE" }, { "scope": "funding", "param": "grant_max", "det": 500000, "llm": 500000, "quote": "Maximum grant per project EUR 500,000", "confidence": 0.95, "verdict": "AGREE" }, { "scope": "funding", "param": "cofinance_rate", "det": 0.6, "llm": 0.6, "quote": "Co-financing rate 60% of eligible costs (applicant funds the other 40%)", "confidence": 0.95, "verdict": "AGREE" } ], "scout": { "status": "ok", "provider": "openai", "budget_s": 75, "unfinished": 0, "researched": 4, "numeric_estimates": 3, "findings": [ { "gap_id": "GAP-01", "market": "Germany", "field": "opportunistic testing volume", "status": "ok", "provider": "openai", "model": "gpt-5.1", "estimate": null, "unit": "annual tests (statutory-insured population)", "range": null, "as_of": "2023", "reasoning": "Publicly available KBV/Zi and Versorgungsatlas publications distinguish iFOBT usage overall but do not provide separate national billing volumes for opportunistic (non\u2011programme) iFOBT, nor EBM\u2011code\u2013level 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 \u00a7295 SGB V billing data.", "sources": [ { "title": "Zi-Trendreport 2023 Q4 \u2013 Kategorie \"Bestimmung von okkultem Blut im Stuhl (iFOBT)\"", "url": "https://www.zi.de/fileadmin/Downloads/Service/Publikationen/2024-06-21_TrendReport_2023-Q4__002_.pdf", "date": "2024-06-21" }, { "title": "Inanspruchnahme der Darmkrebsfr\u00fcherkennung in den Jahren 2009 bis 2018 \u2013 eine Bestandsaufnahme auf Basis bundesweiter vertrags\u00e4rztlicher Abrechnungsdaten", "url": "https://www.versorgungsatlas.de/fileadmin/ziva_docs/108/VA_Bericht_20-02_Darmkrebsfr%C3%BCherkennung_2020-05-14.pdf", "date": "2020-05-14" }, { "title": "KBV Praxisinformation Darmkrebsfr\u00fcherkennung \u2013 iFOBT, EBM-GOP 01737/01738", "url": "https://www.kbv.de/praxis/patientenversorgung/praevention/darmkrebsfrueherkennung", "date": "2026-02-01" }, { "title": "Darmkrebsfr\u00fcherkennung: Versicherte nutzen Test dreimal h\u00e4ufiger bei erleichtertem Zugang (Pressemitteilung DKFZ)", "url": "https://www.dkfz.de/aktuelles/pressemitteilungen/detail/darmkrebsfrueherkennung-versicherte-nutzen-test-dreimal-haeufiger-bei-erleichtertem-zugang", "date": "2018-03-07" }, { "title": "Zi \u2013 Externe Datenanfragen (Hinweis auf bundesweite vertrags\u00e4rztliche Abrechnungsdaten gem. \u00a7 295 SGB V)", "url": "https://www.zi.de/service/externe-datenanfragen", "date": "2026-08-12" } ], "confidence": 0.2, "raw": "{\"estimate\": null, \"unit\": \"annual tests (statutory-insured population)\", \"range\": null, \"as_of\": \"2023\", \"reasoning\": \"Publicly available KBV/Zi and Versorgungsatlas publications distinguish iFOBT usage overall but do not provide separate national billing volumes for opportunistic (non\u2011programme) iFOBT, nor EBM\u2011code\u2013level 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 \u00a7295 SGB V billing data.\", \"sources\": [{\"title\": \"Zi-Trendreport 2023 Q4 \u2013 Kategorie \\\"Bestimmung von okkultem Blut im Stuhl (iFOBT)\\\"\", \"url\": \"https://www.zi.de/fileadmin/Downloads/Service/Publikati", "cached": true }, { "gap_id": "GAP-02", "market": "all", "field": "competitor list price", "status": "ok", "provider": "openai", "model": "gpt-5.1", "estimate": 1495, "unit": "USD per test", "range": null, "as_of": "2025", "reasoning": "Multiple independent clinical and policy analyses describe Guardant Health\u2019s Shield blood-based colorectal cancer screening test\u2014a key competitor\u2014as 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.", "sources": [ { "title": "A Blood-Based Test for Colorectal Cancer Screening", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12795244/", "date": "2024-12-01" }, { "title": "Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12302969/", "date": "2024-08-01" }, { "title": "Guardant Health Receives ADLT Status From CMS for Shield Blood Test", "url": "https://investors.guardanthealth.com/press-releases/press-releases/2025/Guardant-Health-Receives-ADLT-Status-From-CMS-for-Shield-Blood-Test/default.aspx", "date": "2025-03-11" }, { "title": "AGA Clinical Practice Update on Current Role of Blood Tests for Colorectal Cancer Screening: Commentary", "url": "https://www.cghjournal.org/article/S1542-3565(25)00320-9/pdf", "date": "2025-08-01" }, { "title": "Guardant Health: capabilities and pricing | AI Health Index", "url": "https://aihealthindex.io/vendors/guardant-health", "date": "2026-08-14" } ], "confidence": 0.63, "raw": "{\"estimate\": 1495, \"unit\": \"USD per test\", \"range\": null, \"as_of\": \"2025\", \"reasoning\": \"Multiple independent clinical and policy analyses describe Guardant Health\u2019s Shield blood-based colorectal cancer screening test\u2014a key competitor\u2014as 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.\", \"sources\": [{\"title\": \"A Blood-Based Test for Colorectal Cancer Screening\", \"url\": \"https://pmc.ncbi.nlm.nih.gov/articles/PMC12795244/\", \"date\": \"2024-12-01\"}, {\"title\": \"Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer\",", "cached": true }, { "gap_id": "GAP-03", "market": "company", "field": "IVDR certification timeline", "status": "ok", "provider": "openai", "model": "gpt-5.1", "estimate": 18, "unit": "months", "range": [ 12, 24 ], "as_of": "2024", "reasoning": "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\u201324 months from formal application to certificate is reasonable.", "sources": [ { "title": "MDCG 2022-11 Rev.1 \u2013 Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements", "url": "https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf", "date": "2023-11-17" }, { "title": "MedTech Europe 2024 Regulatory Survey \u2013 IVDR & MDR Survey Results 2024", "url": "https://www.medtecheurope.org/wp-content/uploads/2025/01/mte_report_ivdr_mdr_2024-v7.pdf", "date": "2024-05-03" } ], "confidence": 0.6, "raw": "{\"estimate\": 18, \"unit\": \"months\", \"range\": [12, 24], \"as_of\": \"2024\", \"reasoning\": \"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\u201324 months from formal application to certificate is reasonable.\", \"sources\": [{\"title\": \"MDCG 2022-11 Rev.1 \u2013 Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements\", \"url\": \"https://health.e", "cached": true }, { "gap_id": "GAP-04", "market": "all", "field": "penetration benchmark", "status": "ok", "provider": "openai", "model": "gpt-5.1", "estimate": 0.5, "unit": "proportion_of_eligible_population_completing_triage_test_within_3_years_of_program_start", "range": [ 0.4, 0.7 ], "as_of": "2024", "reasoning": "Population-based FIT programmes using stool tests as the main triage modality typically reach participation rates in the 50\u201370% 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.", "sources": [ { "title": "Colorectal cancer screening with faecal immunochemical test: Patterns of participation", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10877995/", "date": "2023-01-01" }, { "title": "Adherence to colorectal cancer screening: four rounds of faecal immunochemical test-based screening", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5220157/", "date": "2016-01-26" }, { "title": "Implementation of population screening for colorectal cancer by repeated Fecal Immunochemical Test (FIT): third round", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3407009/", "date": "2012-07-23" }, { "title": "Impact of delayed screening invitations on screen-detected and interval cancers in the Dutch colorectal cancer screening programme: individual-level data analysis", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10314061/", "date": "2023-06-21" }, { "title": "FIT yields decline after the first round (Catalonia organized CRC screening)", "url": "https://news.gastro.org/issues/2026/february/fit-yields-decline-after-the-first-round/", "date": "2026-02-01" } ], "confidence": 0.5, "raw": "{\"estimate\": 0.5, \"unit\": \"proportion_of_eligible_population_completing_triage_test_within_3_years_of_program_start\", \"range\": [0.4, 0.7], \"as_of\": \"2024\", \"reasoning\": \"Population-based FIT programmes using stool tests as the main triage modality typically reach participation rates in the 50\u201370% 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.\", \"sources\": [{\"title\": \"Colorectal cancer screening with faec", "cached": true } ], "applied": [ "GAP-02: competitor list price \u20ac1,495 recorded", "GAP-04: ramp \u00d72.50 (web benchmark 50% vs the pack's 20%)" ], "held": [ "GAP-01: no numeric estimate", "GAP-03: informational only (IVDR certification timeline)" ], "ramp_mult": 2.5, "note": "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.", "closed_world": { "ranking": [ "Netherlands", "Germany", "Portugal", "Poland" ], "recommendation": "Netherlands", "results": { "Portugal": { "break_even_year": null, "min_cash": -3667392, "end_cash": -3667392, "insolvent": true }, "Germany": { "break_even_year": 4, "min_cash": -1405789, "end_cash": 4697279, "insolvent": true }, "Netherlands": { "break_even_year": 3, "min_cash": 1296589, "end_cash": 9628669, "insolvent": false }, "Poland": { "break_even_year": null, "min_cash": -4071151, "end_cash": -4071151, "insolvent": true } } } }, "conclusion_closed_world": { "ranking": [ "Netherlands", "Germany", "Portugal", "Poland" ], "recommendation": "Netherlands", "results": { "Portugal": { "break_even_year": null, "min_cash": -3667392, "end_cash": -3667392, "insolvent": true }, "Germany": { "break_even_year": 4, "min_cash": -1405789, "end_cash": 4697279, "insolvent": true }, "Netherlands": { "break_even_year": 3, "min_cash": 1296589, "end_cash": 9628669, "insolvent": false }, "Poland": { "break_even_year": null, "min_cash": -4071151, "end_cash": -4071151, "insolvent": true } } }, "vision": { "candidates": [], "transcribed": [], "skipped": [], "pages": 0, "calls": 0 }, "diagnosis": [], "llm_log": [] }