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  • TEC2: What is the FEMTELLE® uPA/PAI-1 ELISA test?
  • TEC3: What is the MammaPrint® test? Jump to
  • TEC4: What is the Oncotype DX™ test? Jump to
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What is the FEMTELLE® uPA/PAI-1 ELISA test?

Authors: Pseudo169 Pseudo169, Pseudo90 Pseudo90, Pseudo154 Pseudo154, Pseudo98 Pseudo98

Internal reviewers: Patricia Harrington, Michelle O'Neill, Leonor Varela

The manufacturer’s website and direct questions to the manufacturer were used to develop this assessment element.

FEMTELLE is a test (classified as an in vitro diagnostic device [IVD]) manufactured by American Diagnostica Inc. (Sekisui Diagnostics LLC from April 2012). It is a prognostic test for primary breast cancer that allows a quantitative determination of the two prognostic factors uPA and its inhibitor PAI-1 in tumour tissue by ELISA technology. The test helps to determine the risk of disease recurrence and to predict the likely benefit from chemotherapy in breast cancer patients. The breast cancer tumour tissue is surgically removed. The specimen is transported fresh (unfixed) to the pathologist who proceeds with the removal of a representative piece of tumour tissue (> 50 mg). The uPA and PAI-1 are extracted and the FEMTELLE test performed by ELISA {2}. If the patient samples need to be shipped to another clinical centre or diagnostic laboratory (Institute of Pathology, laboratories at breast cancer centres or private diagnostic laboratories – decentralised testing) for testing, the frozen samples must be shipped on dry ice. The results are communicated within 3–4 days after receiving the sample. The patient samples have to be kept frozen (-20°C or colder) until test performance. Before shipping of the samples, they can be stored (-20°C or colder) for up to 3 weeks {Appendix COL-2}. More information on FEMTELLE is available in the Appendix “Characteristics of the tests assessed” {TEC-1}.

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Pseudo169 P et al. Result Card TEC2 In: Pseudo169 P et al. Description and technical characteristics of technology In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

What is the MammaPrint® test?

Authors: Pseudo169 Pseudo169, Pseudo90 Pseudo90, Pseudo154 Pseudo154, Pseudo98 Pseudo98

Internal reviewers: Patricia Harrington, Michelle O'Neill, Leonor Varela

The manufacturer’s website and direct questions to the manufacturer were used to develop this assessment element.

MammaPrint is a qualitative in vitro diagnostic test service that was commercially developed by Agendia BV. MammaPrint is not a commercially available IVD device; it is a testing service provided at the manufacturer’s laboratories. MammaPrint uses the gene expression profile of fresh/fresh frozen or FFPE breast cancer tissue samples to assess a patient’s risk of distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with all the other clinicopathological factors {Appendix COL-2}. The analysis is based on several sequential processes: isolation of RNA from FFPE tumour tissue sections, DNase treatment of isolated RNA, linear amplification and labelling of DNase-treated RNA, cRNA purification, hybridisation of the cRNA to the MammaPrint microarray, scanning the MammaPrint microarray and data acquisition (feature extraction), calculation and determination of the risk of recurrence in breast cancer patients. The MammaPrint analysis is designed to determine the gene activity of specific genes in a tissue sample compared with a reference standard. The result is an expression profile, or fingerprint, of the sample. The correlation of the sample expression profile with a template (the mean expression profile of 44 tumours with known good clinical outcome) is calculated and the molecular profile of the sample is determined (low risk, high risk) {Appendix COL-2}. The specimen (FFPE tissue taken from a surgical specimen) has to be shipped according to a specific protocol provided by the manufacturer. Once the specimen arrives at the manufacturer’s laboratory, results will be available within 10 working days (by email, fax, hard copy and/or secure intranet account) to the requesting physician {3}. FFPE samples can be sent at room temperature (the manufacturer receives the sample the day after shipment) {Appendix COL-2}. More information on MammaPrint is available in the Appendix “Characteristics of the tests assessed” {TEC-1}.

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Pseudo169 P et al. Result Card TEC3 In: Pseudo169 P et al. Description and technical characteristics of technology In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

What is the Oncotype DX™ test?

Authors: Pseudo169 Pseudo169, Pseudo90 Pseudo90, Pseudo154 Pseudo154, Pseudo98 Pseudo98

Internal reviewers: Patricia Harrington, Michelle O'Neill, Leonor Varela

The manufacturer’s website was used to develop this assessment element.

Oncotype DX Breast Cancer Test (Oncotype DX) is multi-gene diagnostic assay that predicts the likelihood of benefit from adjuvant chemotherapy in a subset of breast cancer patients. This is not a commercially available IVD device; it is a testing service provided at the manufacturer’s laboratory {Appendix COL-2}. Oncotype DX quantifies gene expression for 21 genes (16 cancer-related genes and 5 reference genes) in breast cancer tissue by reverse transcriptase-polymerase chain reaction (RT-PCR). First, RNA is extracted from the breast cancer tumour specimen and purified. The RNA is then analysed by real-time RT-PCR. Finally, the recurrence score (RS, corresponding to a point estimate of the 10-year risk of distant recurrence with a 95% CI for an individual patient) is calculated from the gene expression results {4} {5}. To quantify gene expression, RNA is extracted from FFPE tumour tissue and subjected to DNase I treatment. Total RNA content is measured and the absence of DNA contamination is verified. Reverse transcription is performed and is followed by quantitative TaqMan (Roche Molecular Systems, Inc.) RT-PCR reactions in 384-well plates. The expression of each of 16 cancer genes is measured in triplicate and then normalised relative to a set of 5 reference genes {4}. The specimen (tissue block or slides) has to be shipped according to a specific protocol provided by the manufacturer. Once the specimen arrives at the manufacturer’s laboratory, typical processing time for the test to be completed is 7–10 days. The result is sent (by secure intranet account or fax) to the requesting physician {6}. Shipping of the sample is organised via FedEx in priority and takes a maximum of 3 days {Appendix COL-2}. More information on Oncotype DX is available in the Appendix “Characteristics of the tests assessed” {TEC-1}.

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Pseudo169 P et al. Result Card TEC4 In: Pseudo169 P et al. Description and technical characteristics of technology In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

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