(603 days)
MammaPrint® is a gualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patients' risk for distant metastasis (up to 10 years for patients less than 61 years old, up to 5 years for patients ≥ 61 years).
The test is performed for breast cancer patients with Stage I or Stage II disease, with a tumor size of ≤ 5.0 cm and lymph node negative. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.
The MammaPrint service is a microarray based gene expression analysis of a tumor. The analysis is based on several processes: isolation of RNA from frozen tumor tissue sections, DNA'se treatment of isolated RNA, linear amplification and labeling of DNA'se treated RNA, cRNA purification, hybridization of the cRNA to the MammaPrint microarray, scanning the MammaPrint microarray and data acquisition (feature extraction), index calculation and determination of the risk of distant recurrence in breast cancer patients.
The MammaPrint analysis is designed to determine the gene activity of specific genes in a tissue sample compared to a reference standard. The result is an expression profile, or fingerprint, of the sample.
The correlation of the sample expression profile to a template (the mean expression profile of 44 tumors with a known good clinical outcome) is calculated and the molecular profile index of the sample is determined (Low Risk, High Risk).
Here's a breakdown of the acceptance criteria and the study information for the MammaPrint® device, based on the provided text:
MammaPrint® Acceptance Criteria and Study Information
1. Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on analytical performance as internally validated and clinical performance as demonstrated through peer-reviewed studies. It doesn't explicitly state "acceptance criteria" in a typical pass/fail numerical sense for clinical performance, but rather presents the performance achieved by the device in various clinical settings.
| Acceptance Criteria Category | Specific Metric/Description | Reported Device Performance/Finding |
|---|---|---|
| Analytical Performance | Accuracy of measurement (based on repeated experiments of control samples) | 98.5% Analytical Accuracy of measurement |
| Accuracy of classifying a sample as High Risk or Low Risk | At least 98.9% (i.e., 1.1% false negative classification) | |
| Percentage of "Borderline Samples" | Less than 5% of analyzed samples are considered "Borderline Samples" | |
| Classification accuracy for "Borderline Samples" | Approximately 90% (i.e., 10% chance of false classification) | |
| Clinical Performance | **Assessment of risk for distant metastasis (up to 10 years for patients |
§ 866.6040 Gene expression profiling test system for breast cancer prognosis.
(a)
Identification. A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.