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Clinical calculator summary

MammaPrint FFPE Microarray K201902 Reported MPI Interpreter

This route is limited to the FDA-cleared MammaPrint FFPE microarray service described by K201902, with the four reported categories and exact MPI thresholds documented in K141142.

Evidence-based context for fast calculator use

Purpose:
Strictly interprets an externally reported MammaPrint FFPE microarray MPI and matching report category using FDA K201902 and the unchanged K141142 thresholds.
Population:
patients undergoing breast cancer risk, staging, pathology, recurrence, or treatment-benefit assessment
Factors:
Reported MammaPrint Result, Reported MammaPrint Index, Disease Stage, Tumor Size, Lymph Node Status
HomeMammaPrint FFPE Microarray K201902 Reported MPI Interpreter
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MammaPrint FFPE Microarray K201902 Reported MPI Interpreter

Clinical Context & Background

This route is limited to the FDA-cleared MammaPrint FFPE microarray service described by K201902, with the four reported categories and exact MPI thresholds documented in K141142. It is a prognostic adjunct for node-negative Stage I or II invasive breast cancer, FFPE breast tumor tissue, and tumor size greater than 0 through 5.0 cm. It does not calculate the proprietary 70-gene expression profile or MPI and does not provide a patient-specific outcome, treatment response, benefit, or treatment recommendation.
The distinct K210973 FFPE NGS system, fresh or frozen assays, node-positive disease, other stages, recurrent or metastatic disease, BluePrint, UltraLow reporting, and standalone or therapy-prediction use are outside this interpreter.
Formula Logic
Reported microarray MPI: -1 to < -0.0575 High; -0.0575 to 0 inclusive High Borderline; >0 to 0.0575 inclusive Low Borderline; >0.0575 to 1 Low. MPI <=0 is the High family; MPI >0 is the Low family.

Reference Data

Reported resultExact K141142 microarray MPI intervalFamily
High-1 <= MPI < -0.0575High
High Borderline-0.0575 <= MPI <= 0High
Low Borderline0 < MPI <= 0.0575Low
Low0.0575 < MPI <= 1Low

Clinical Workflow

Use, Interpret, And Continue The Patient Pathway

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

When To Use

  • Use MammaPrint FFPE Microarray K201902 Reported MPI Interpreter when strictly interprets an externally reported MammaPrint FFPE microarray MPI and matching report category using FDA K201902 and the unchanged K141142 thresholds.
  • Confirm that the patient, diagnosis, disease phase, and available inputs match the cited model before calculation.

How To Interpret

  • Interpret the displayed result using the calculator-specific formula and reference table, spanning High through Low.
  • A boundary result should prompt input verification and clinical review rather than false precision.

What To Do Next

  • Integrate the result with invasive versus in-situ status, stage, receptor biology, treatment timing, genomic testing, comorbidity, and patient goals.
  • Document the inputs, result, timing, and clinical context so the assessment can be reproduced.

Limitations

  • Do not interchange screening-risk, DCIS, invasive prognosis, genomic, and post-neoadjuvant tools.
  • The result supports clinician judgment and does not independently determine treatment.

Validated Population

patients undergoing breast cancer risk, staging, pathology, recurrence, or treatment-benefit assessment

How to apply this result

For a representative case, verify Reported MammaPrint Result, Reported MammaPrint Index, Disease Stage, calculate the result, and confirm that its classification matches the highlighted reference band before continuing the disease-specific pathway.

Breast Cancer hubContinue to related calculators and clinical workflow resources.

Calculation verification history

Verified

  1. : Production browser revalidation

    • Three source-backed MammaPrint cases passed through visible production controls across High, the exact MPI=0 High Borderline boundary, and node-positive Not Applicable.
    • The unsupported generic risk gauge was absent; no unexpected N/A, literal undefined value, stale control, or browser-console error was observed.
    Download latest production check (Excel)

    Case-level evidence is retained in validation/browser-revalidation/mammaprint-70-gene-breast-cancer-2026-08-03.json.

  2. : Local browser remediation

    • All MammaPrint interpreter outcomes now explicitly suppress the shared generic risk gauge so the four reported assay categories are not collapsed or relabeled.
    • Ten source-backed cases passed through visible local browser controls across 11 submissions, covering all four categories, exact MPI thresholds, intended-use exclusion, contradictory-report rejection, and reset/repeat behavior.
    • The existing calculator-specific audit passed 557/557. Production status remains open until this commit is deployed and the public route is revalidated.

    Local case-level remediation evidence is retained in validation/browser-production/mammaprint-70-gene-breast-cancer.local-remediation.json.

  3. : Production browser validation

    • Ten source-backed cases were exercised on the public production route through visible browser controls; 0/10 case records passed their expected-versus-observed assertions across 11 visible submissions.
    • Overall browser status: failed-ui-and-console. high: Every classified, not-applicable, and invalid result displays a generic Low Risk / Intermediate / High Risk gauge that is not part of this exact four-category reported-assay interpreter and conflicts with the source-defined High, High Borderline, Low Borderline, and Low categories. | medium: Production emitted minified React error #418 during the route load.
    • 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/mammaprint-70-gene-breast-cancer.json.

  4. : 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.

  5. : Full validation test

    • 557/557 independently expected lineage, score, boundary, parity, malformed-input, applicability, wording, trace, UI, immutability, registry, inventory, report, history, and mirror assertions passed with zero category mismatch.
    • This is source-to-code implementation verification, not independent clinical validation, individualized outcome prediction, or treatment guidance.

  6. : Correction

    • Locked the route to FDA K201902 FFPE microarray interpretation with unchanged K141142 thresholds and explicitly separated the K210973 NGS variant.
    • Added the raw MPI and all four microarray report categories, corrected exact -0.0575, 0, and +0.0575 boundaries, and removed defaults, clinical-risk synthesis, coercion, and stale result behavior.
    • Added exact FDA applicability gates and removed UltraLow, BluePrint, percentages, proprietary derivation, standalone outcome claims, chemotherapy benefit, and treatment recommendations.

    Included in the current validation report.

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

When should MammaPrint FFPE Microarray K201902 Reported MPI Interpreter be used?

Use it for patients undergoing breast cancer risk, staging, pathology, recurrence, or treatment-benefit assessment when all required inputs and the intended clinical setting are confirmed.

Can MammaPrint FFPE Microarray K201902 Reported MPI Interpreter determine treatment by itself?

No. Interpret the result with the cited evidence, complete clinical assessment, current guidelines, and patient-specific goals.

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