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Symphony TargetPrint®

General considerations

Obtaining of final results through full human genome analysis

The SYMPHONY gene signature development process started with the identification of two groups of women who suffered breast cancer: those suffering a relapse five years after surgery and those who remained free from the disease after five years. The 25,000 genes of the human genome were analysed in both groups, identifying the differences in gene expression. It should be said that none of the women from either group received chemotherapy or hormone therapy. This control process enables the intrinsic biology of the tumours to be monitored for more than 20 years, thereby finally ensuring the obtaining of a definitive result that can be used as a basis for action in each patient.

The benefit — results that are 100% conclusive

The results of SYMPHONY are valid at the time of the diagnosis. The gene signatures were developed separately from the pharmacological treatment. Consequently the test results will indicate the prognosis of the patient if no treatment is applied. It is not necessary to start with the assumption that the patient will continue with a specific treatment to validate the test results. This makes the SYMPHONY genome test unit the perfect complement for your current protocols.

The personalized SymphonyTM breast cancer profile: Ferrer inCode offers you a wide range of tests for breast cancer that allow you to personalize the patient's treatment, depending on the likelihood of relapse.  

Studies underway

The studies published recently complement the data on the clinical, prognostic and predictive usefulness of MammaPrint® in patients at the early stages of breast cancer. Multi-centre clinical studies such as MINDACT and ISPY-2 are expected to increase the clinical relevance of the platform. Recently, the results of the prospective five-year RASTER study were presented, indicating that chemotherapy could be eliminated in patients at low risk without compromising their evolution.

Studies

 

# total  patients

Timelines

MINDACT

Randomized  trial
MP TP

6600

2007-2011

I-SPY2

Neo-adjuvant adaptive trial
MP TP Her2

800

2010-2013

Ethnicity study Swain

Ethnicity study
MP,BP,TP,ThP

100

2010-2012

Hong Kong/US

Molecular Risk Panels in Chinese Breast Cancer Patient

100

2011-2013

MINT (US)

Neo-adjuvant: Predictiveness MammaPrint and BluePrint
MP,BP TP, ThP full genome

226

2011-2013

NBRST (US)

Registry neo-adjuvant setting
MP,BP,(TP), ThP

500

2011-2013

PROMIS (US)

Symphony suite in BC patients with an ODX intermediate score

300

2012-2014

NBREaST II (ROW)

Registry neo-adjuvant setting
MP,BP,TP,

250

2012-2014

Meta Diagnostics (US)

Multicenter study of adoption, utilization, and actionability of the Agendia Symphony suite to support optimal market access

400-600

2012-2013

MP = MammaPrint, BP = BluePrint, TP= TargetPrint, ThP = TheraPrint

About

TargetPrint® quantifies the OR, PR and HER2 status

TargetPrint® is a microarray-based gene expression test that quantifies the oestrogen receptor (OR) expression levels, progesterone receptor (PR) and the HER2/neu receptor overexpression in patients with breast cancer. TargetPrint® complements the information provided by MammaPrint® to facilitate decision-taking by the clinician with respect to the patient's treatment.

Indications

TargetPrint® provides an additional benefit to the diagnostic process.

Compared to immunohistochemistry (IHQ) TargetPrint® provides an additional benefit to the diagnostic process. IHQ provides semi-quantitative positive or negative results, whereas the gene expression result furnished by TargetPrint® enables clinicians to integrate the absolute gene expression of OR, PR and HER2.

Scientific evidence

Validation of TargetPrint®

TargetPrint® has been validated in more than 500 breast cancer tumour samples in 3 independent studies. The validation was obtained with immunohistochemistry (IHQ) in a national independent laboratory of reference accredited by CAP and CLIA.

The microarray values for the oestrogen receptor (OR), progesterone receptor (PR) and HER2 were compared to the centralised IHQ results in a laboratory, reaching a concordance of 93% (95CI: 91-95%) for OR, a concordance of 83% (95CI: 80-86%) for PR and a concordance of 96% (95CI: 94-98%) for HER2, respectively. A threshold of 1% of tumour cells stained by IHQ as positive was considered for OR and PR and a score of 3+ was considered HER2-positive. In the case of samples with 2+, a FISH HER2 amplification was evaluated (1,2). 


  • Ach et al., 2007, Robust inter-laboratory reproducibility of a gene-expression signature measurement consistent with the needs of a new generation of diagnostic tools. BMC Genomics 8; 148
  • Glas et al., 2006, Converting a breast cancer microarray signature into a high-throughput diagnostic test, BMC Genomics, 7:278

Accreditations


 CE mark

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