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Clinical calculator summary

Roche Elecsys ROMA ovarian risk algorithm

An assay-specific logistic regression using Elecsys HE4, Elecsys CA 125 II, and menopausal status.

Evidence-based context for fast calculator use

Purpose:
Reproduce the manufacturer ROMA probability and low/high classification for an eligible patient with a pelvic mass.
Population:
Women age 18 or older with a pelvic mass, no previous malignancy treatment or current chemotherapy, and Roche Elecsys marker results in range.
Factors:
Menopausal status, Elecsys HE4, Elecsys CA 125 II, Age and pelvic-mass eligibility, Treatment exclusions, Assay platform
Reference:
Roche Elecsys HE4 method sheet v7.0, 2024-05.
HomeROMA Score (Ovarian)
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ROMA Score (Ovarian)

U/mL
pmol/L

Clinical Context & Background

This calculator implements the Roche Elecsys ROMA algorithm using Elecsys HE4 and Elecsys CA 125 II, method sheet version 7.0 dated May 2024. It uses natural logarithms, the manufacturer equations, and the assay-specific cutoffs of 11.4% before menopause and 29.9% after menopause. Classification uses the full-precision probability before display rounding.
Use only for a woman age 18 years or older who presents with a pelvic mass and has results from the specified Roche assays within the documented calculation ranges. ROMA is not intended for population screening, standalone diagnosis, patients previously treated for malignancy, or patients receiving chemotherapy. Results from other HE4 or CA125 platforms are not interchangeable.
Interpret ROMA with clinical examination, history, and imaging. Renal or hepatic disease and nonmalignant conditions can elevate HE4, while some mucinous and germ-cell ovarian tumors may express little HE4. The output does not independently determine surgery, referral, or treatment.
Primary implementation source: Roche Diagnostics. Elecsys HE4 method sheet, version 7.0, 2024-05. Development context: Moore RG, et al. Gynecol Oncol. 2009;112(1):40-46.
Formula Logic
Roche Elecsys ROMA: premenopausal PI = -12.0 + 2.38 x ln(HE4) + 0.0626 x ln(CA125); postmenopausal PI = -8.09 + 1.04 x ln(HE4) + 0.732 x ln(CA125); ROMA (%) = 100 x exp(PI) / (1 + exp(PI)). Classify the unrounded result at 11.4% before menopause or 29.9% after menopause.

Reference Data

Roche Elecsys groupRaw ROMA probabilityClassification
Premenopausal< 11.4%Low risk
Premenopausal>= 11.4%High risk
Postmenopausal< 29.9%Low risk
Postmenopausal>= 29.9%High risk

Clinical Workflow

Use, Interpret, And Continue The Patient Pathway

Expand for workflow guidance, limitations, examples, and related next steps.

When To Use

  • Use only for a woman age 18 years or older who presents with a pelvic mass and has Roche Elecsys HE4 and Elecsys CA 125 II results.
  • Confirm menopausal status explicitly and document the assay platform and units before calculation.

How To Interpret

  • Compare the raw, unrounded probability with the assay-specific 11.4% premenopausal or 29.9% postmenopausal cutoff.
  • Treat low/high as the manufacturer classification, not a diagnosis or individualized treatment recommendation.

What To Do Next

  • Interpret the result with clinical examination, history, ultrasound morphology, and other imaging findings.
  • Make referral, surgical, and treatment decisions separately using current guidance and specialist assessment.

Limitations

  • Not for screening, patients younger than 18, patients without a pelvic mass, previous malignancy treatment, or current chemotherapy.
  • Do not substitute another HE4 or CA125 assay platform or values outside the documented calculation ranges.
  • Renal, hepatic, and nonmalignant disease can elevate HE4; some mucinous and germ-cell ovarian tumors rarely express HE4.

Validated Population

Women presenting with a pelvic mass who meet the Roche Elecsys method-sheet population and assay requirements.

Preserve assay and raw-threshold context

Document status, Roche assay platform, raw markers, PI, unrounded ROMA probability, and the applicable cutoff so the result is reproducible.

Gynecologic oncology hubReview related gynecologic oncology tools.O-RADS ultrasoundReview the separate ultrasound-based assessment.RMI-I ovarian riskReview the distinct original RMI-I model and inputs.

Calculation verification history

Verified

  1. : Production browser revalidation

    • Three Roche method-sheet examples passed through visible production controls at 4.3%, 91.5%, and 12.5%.
    • Premenopausal and postmenopausal branches produced their expected assay-specific risk classifications.
    • No unexpected N/A, literal undefined value, stale control, unsupported gauge, or browser-console error was observed.
    Download latest production check (Excel)

    Case-level evidence is retained in validation/browser-revalidation/roma-ovarian-2026-08-03.json.

  2. : Production browser validation

    • Ten source-backed cases were exercised on the public production route through visible browser controls; 10/10 case records passed their expected-versus-observed assertions across 13 visible submissions.
    • Overall browser status: failed-console. medium: Production emitted minified React error #418 during route loads.
    • Case-level inputs, expected and observed results, reset/repeat behavior, failure reproductions, and console evidence are retained in the production-browser evidence record.

    Case-level production evidence is retained in validation/browser-production/roma-ovarian.json.

  3. : Input workflow simplified and revalidated

    • Reduced the public form to result-, branch-, unit-, and applicability-changing inputs; removed or consolidated non-scoring, administrative, and duplicate questions.
    • Preserved the verified calculation or report-interpretation logic, thresholds, model version, component logic, and supported result pathways behind strict deterministic adapters.
    • Passed the calculator-specific regression audit, adapter-parity and malformed-input checks, the 144-calculator input-quality audit, and the 43-calculator entry-burden audit.

  4. : Full validation test

    • 512/512 numerical, manufacturer-example, marker-range, raw-cutoff, display-rounding, malformed-input, UI, trace, scope, report, registry, immutability, and isolation checks passed.
    • No registered master panel calculates ROMA; no panel receives inherited verification.

  5. : Calculation and input-contract correction

    • Changed classification to use the raw unrounded ROMA probability and enforced the Roche Elecsys CA 125 II range of 6.42-5000 U/mL and HE4 range of 28.8-3847 pmol/L.
    • Removed favorable menopausal defaults, coercion, unsupported assay mixing, and implicit eligibility; added explicit age, pelvic-mass, Roche-assay, previous-treatment, and current-chemotherapy assessment with non-calculated applicability outcomes.

Verification confirms the calculator implementation against the cited model; it is not independent clinical validation, regulatory approval, or medical advice.

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Frequently Asked Questions

Is ROMA an ovarian cancer screening test?

No. This Roche ROMA implementation is for an eligible woman presenting with a pelvic mass, not population screening or standalone diagnosis.

Can HE4 or CA125 results from another assay be entered?

No. The formulas, ranges, and cutoffs here are locked to Roche Elecsys HE4 and Elecsys CA 125 II; assay platforms are not interchangeable.

Does rounding determine the risk group?

No. The full-precision ROMA probability is compared with 11.4% or 29.9%; rounding to one decimal place is display-only.

Evidence-based oncology decision support. Verify with clinical guidelines.