Kolln-reisiek, Germany
Kolln-reisiek, Germany

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A method for predicting a response to and/or benefit of chemotherapy, including neoadjuvant chemotherapy, in a patient suffering from or at risk of developing recurrent neoplastic disease, in particular breast cancer, said method comprising the steps of: (a) determining in a tumor sample from said patient the RNA expression levels of the following 8 genes: UBE2C, RACGAP1, DHCR7, STC2, AZGP1, RBBP8, IL6ST, and MGP, indicative of a response to chemotherapy for a tumor, or (b) determining in a tumor sample from said patient the RNA expression levels of the following 8 genes: UBE2C, BIRC5, DHCR7, STC2, AZGP1, RBBP8, IL6ST, and MGP; indicative of a response to chemotherapy for a tumor(c) mathematically combining expression level values for the genes of the said set which values were determined in the tumor sample to yield a combined score, wherein said combined score is predicting said response and/or benefit of chemotherapy.


Patent
Sividon Diagnostics | Date: 2016-08-11

The present invention relates to methods, kits and systems for the prognosis of the disease outcome of breast cancer, said method comprising:


Patent
Sividon Diagnostics | Date: 2015-03-11

The present invention relates to methods, kits and systems for the prognosis of the disease outcome of breast cancer, said method comprising:(a) determining in a tumor sample from said patient the RNA expression levels of at least 2 of the following 9 genes: UBE2C, BIRC5, RACGAP1, DHCR7, STC2, AZGP1, RBBP8, IL6ST, and MGP(b) mathematically combining expression level values for the genes of the said set which values were determined in the tumor sample to yield a combined score, wherein said combined score is indicative of a prognosis of said patient; and kits and systems for performing said method.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2011.1.1-2 | Award Amount: 7.78M | Year: 2012

Individualisation of cancer therapy based on standardized biomarker assays is one of the most demanding challenges in cancer medicine. In the RESPONSIFY consortium, we will integrate information on response prediction from different breast cancer types and methodologies into biomarker tests for targeted therapies in the clinical routine setting. Those tests will be developed for commercialisation using the expertise of the involved SMEs and industrial partners. To reach this aim, we will use different genome based strategies to identify and characterise new biomarkers as well as validate biomarkers from previous projects. Genome based strategies include new molecular techniques such as genome wide next generation sequencing, epigenetics, gene and exon expression analysis, as well as kinome arrays, in-situ proteomics and quantitative PCR using FFPE tissue. A clearly defined marker finding-training-validation-approach will be the backbone of RESPONSIFY to reach a high level of evidence for commercial diagnostic tests. The established therapy stratification criteria will be further validated within clinical trials using the expertise of the clinical study groups. The clinical study group will develop a web-based data integration and processing system to standardise integration of clinical trial data and biomarker results in one system which will be further used for clinical biomarker driven trials. Health economic characteristics of combined testing and treatment strategies will be determined to inform decision makers, using state-of-the-art cost-utility analysis. Optimising the use of current therapy options and avoiding treatments patients will predictably not respond to, may improve cost-utility parameters to levels acceptable for most health systems. For rapid evaluation of response parameters, the major focus will be on neoadjuvant therapy. The RESPONSIFY project will lead to validated tests based on formalin-fixed paraffin embedded tissue to predict resistance


Grant
Agency: Cordis | Branch: H2020 | Program: SME-1 | Phase: PHC-12-2015-1 | Award Amount: 71.43K | Year: 2015

SIVIDON established a prototype diagnostic assay - the ChemoPredict test - to stratify high-risk breast cancer patients and to help in deciding whether to treat the patient with standard anthracycline-based chemotherapy without taxane or taxane-containing regimens. ChemoPredict was clinically validated in a large clinical phase III trial (FinHer) with 919 patients using a prospective-retrospective approach. The existing training and validation studies of ChemoPredict provided evidence that the assay can reduce the number of taxane-based chemotherapies within the tests target group by about 50% without impairment of outcome of the patients. Thus, the use of the assay in breast cancer care will result in a more specific use of taxanes and a reduction of overtreatment thus avoiding serious side effects in patients and saving costs for the health care system. SIVIDONs aim for the overall innovation project is to extend clinical and analytical validation data, to develop ChemoPredict as a CE-marked IVD test according to IVD directive 98/79/EC and to bring this test as a tool for personalized medicine into the European market. The objective of the feasibility study is to generate an elaborated business plan including detailed market analyses for ChemoPredict. Several key opinion leaders will be interviewed to get their perspective on the application, the inclusion into clinical guidelines and market entrance of the innovative predictive test. Phase I will be also used to decide on an extended clinical validation strategy to ensure that the ChemoPredict assay exhibits the highest clinical evidence level. Advisory boards will be initiated, opportunities for entering clinical guidelines will be judged and reimbursement concepts in European countries will be assessed. Regulatory issues will be comprehensively evaluated to decide on the best product development strategy, a detailed product development plan will be generated and phase 0 development strategies will be started.


Patent
Sividon Diagnostics | Date: 2011-03-29

The present invention relates to methods, kits and systems for the prognosis of the disease outcome of breast cancer, said method comprising:


Patent
Sividon Diagnostics | Date: 2012-06-27

The present invention relates to methods for prediction of an outcome of neoplastic disease or cancer. More specifically, the present invention relates to a method for the prediction of breast cancer by determining in a biological sample from said patient an expression level of a plurality of genes selected from the group consisting of ACTG1, CA12, CALM2, CCND1, CHPT1, CLEC2B, CTSB, CXCL13, DCN, DHRS2, EIF4B, ERBB2, ESR1, FBXO28, GABRP, GAPDH, H2AFZ, IGFBP3, IGHG1, IGKC, KCTD3, KIAA0101, KRT17, MLPH, MMP1, NAT1, NEK2, NR2F2, OAZ1, PCNA, PDLIM5, PGR, PPIA, PRC1, RACGAP1, RPL37A, SOX4, TOP2A, UBE2C and VEGF.


A method for predicting a benefit from inclusion of taxane in a chemotherapy regimen in a patient suffering from or at risk of developing recurrent neoplastic disease, in particular breast cancer. Said method comprises the steps of: a) determining in a tumor sample from said patient the expression levels of the marker genes S100P and PCSK6, and b) mathematically combining the expression level values of the genes PCSK6 and S100P to yield a combined score and comparing said combined score to a reference-value, including a cutoff, wherein a high combined score is indicative of a benefit from including a taxane in a chemotherapy regimen of said patient and a low combined score is indicative of not having a benefit from including a taxane in a chemotherapy regimen of said patient or c) mathematically combining the expression level value of PCSK6 and S100P with the expression values of other genes to yield a combined score and comparing said combined score to a reference-value, including a cutoff, wherein a high combined score is indicative of a benefit from including a taxane in a chemotherapy regimen of said patient and a low combined score is indicative of not having a benefit from including a taxane in a chemotherapy regimen of said patient.


A method for predicting a response to and/or benefit of chemotherapy, including neoadjuvant chemotherapy, in a patient suffering from or at risk of developing recurrent neoplastic disease, in particular breast cancer, said method comprising the steps of: (a) determining in a tumor sample from said patient the RNA expression levels of the following 8 genes: UBE2C, RACGAP1, DHCR7, STC2, AZGP1, RBBP8, IL6ST, and MGP, indicative of a response to chemotherapy for a tumor, or (b) determining in a tumor sample from said patient the RNA expression levels of the following 8 genes: UBE2C, BIRC5, DHCR7, STC2, AZGP1, RBBP8, IL6ST, and MGP; indicative of a response to chemotherapy for a tumor (c) mathematically combining expression level values for the genes of the said set which values were determined in the tumor sample to yield a combined score, wherein said combined score is predicting said response and/or benefit of chemotherapy.


The present invention relates to a method for predicting a response of a tumor in a patient suffering from or at risk of developing recurrent gynecologic cancer towards a chemotherapeutic agent, said method comprising the steps of: a) obtaining a biological sample from said patient; b) determining the pattern of expression level of at least one gene of the group comprising AKR1C1, MLPH, ESR1, PGR, COMP, DCN, IGKC, CCL5, FBN1 and/or UBE2C, or of genes coregulated therewith, in said sample; c) comparing the pattern of expression levels determined in (b) with one or several reference pattern(s) of expression levels; d) identifying at least one marker gene; e) determining a molecular subtype for said sample on the basis of (d); and f) predicting from said molecular subtype response of a tumor for a chemotherapeutic agent, wherein the molecular subtype is selected from the group comprising the subtypes basal, stromal-high, stromal-low, luminal A, immune system-high, immune system-low, proliferation-high and/or proliferation-low.

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