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DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "The Top 200 Developers of In-Vitro Diagnostics Tests for Cancer & Infectious Diseases" report to their offering. Did you know? - Lewis Stuart is Vice President, Sales & Marketing, U.S. Breast/Colon at Genomic Health, Inc.. - Beijing Wantai Biological Pharmacy's Beijing plant is the largest manufacturing base for the production of infectious diseases diagnostics in China. - MDxHealth was the winner of the 2016 Frost & Sullivan Global Prostate Cancer Diagnostics Technology Innovation Award. - iTP Biomedica Corp., the Canadian developer of diagnostic tools for cancers, is oriented to collaborative co-diagnostics development. - Arbor Vita Corporation's flagship product - the OncoE6 Cervical Test - has proven to be the most accurate test available worldwide for detecting cervical cancer. It is the only cervical cancer test that provides real-time results at the point-of-care. - On February 1, 2017, Great Basin Scientific, Inc. announced the completion of the clinical trial and 510(k) submission to the FDA of its Bordetella Direct Test. - In July, 2016, the Swiss-based global biopharmaceutical group, Debiopharm Group, acquired a majority holding in GenePOC, Inc., the Canadian developer of affordable, simple, and rapid point-of-care molecular diagnostic tests for infectious diseases. These are just a tiny sample of the 1,000's of facts to be found in The Top 200 Developers Of In-Vitro Diagnostics Tests For Cancer & Infectious Diseases'. This unique and comprehensive report (360 pages) identifies and profiles the leading 200 developers of in-vitro diagnostics tests for cancer and infectious diseases. They are located right across the globe from the United States and Europe to India and China. The Top 200 Developers Of In-Vitro Diagnostics Tests For Cancer & Infectious Diseases' is perfect for suppliers of raw materials, technology and services to identify top potential customers. This report is ideal for distributors of in-vitro diagnostics instruments and tests to identify the leading manufacturers with the best products. The Top 200 Developers Of In-Vitro Diagnostics Tests For Cancer & Infectious Diseases' is a useful reference tool for in-vitro diagnostic associations. Most people will be aware of some of the major developers of in-vitro diagnostics tests for cancer and infectious diseases such as Accugenomics, Inc., Agendia Inc., altona Diagnostics GmbH, Biocept, Inc., bioLytical Laboratories Inc., GeneNews Limited, HiberGene Diagnostics and OvaGene Oncology, Inc. but this major new report looks at all 100 of the top companies. For more information about this report visit http://www.researchandmarkets.com/research/zgswvt/the_top_200


Research and Markets has announced the addition of the "The Top 200 Developers of In-Vitro Diagnostics Tests for Cancer & Infectious Diseases" report to their offering. Did you know? - Lewis Stuart is Vice President, Sales & Marketing, U.S. Breast/Colon at Genomic Health, Inc.. - Beijing Wantai Biological Pharmacy's Beijing plant is the largest manufacturing base for the production of infectious diseases diagnostics in China. - MDxHealth was the winner of the 2016 Frost & Sullivan Global Prostate Cancer Diagnostics Technology Innovation Award. - iTP Biomedica Corp., the Canadian developer of diagnostic tools for cancers, is oriented to collaborative co-diagnostics development. - Arbor Vita Corporation's flagship product - the OncoE6 Cervical Test - has proven to be the most accurate test available worldwide for detecting cervical cancer. It is the only cervical cancer test that provides real-time results at the point-of-care. - On February 1, 2017, Great Basin Scientific, Inc. announced the completion of the clinical trial and 510(k) submission to the FDA of its Bordetella Direct Test. - Meridian Bioscience, Inc. reported full-year fiscal 2016 net revenues of $196.1 million. - In July, 2016, the Swiss-based global biopharmaceutical group, Debiopharm Group, acquired a majority holding in GenePOC, Inc., the Canadian developer of affordable, simple, and rapid point-of-care molecular diagnostic tests for infectious diseases. These are just a tiny sample of the 1,000's of facts to be found in The Top 200 Developers Of In-Vitro Diagnostics Tests For Cancer & Infectious Diseases'. This unique and comprehensive report (360 pages) identifies and profiles the leading 200 developers of in-vitro diagnostics tests for cancer and infectious diseases. They are located right across the globe from the United States and Europe to India and China. 2) Suppliers The Top 200 Developers Of In-Vitro Diagnostics Tests For Cancer & Infectious Diseases' is perfect for suppliers of raw materials, technology and services to identify top potential customers. 3) Distributors This report is ideal for distributors of in-vitro diagnostics instruments and tests to identify the leading manufacturers with the best products. 4) Industry Associations: The Top 200 Developers Of In-Vitro Diagnostics Tests For Cancer & Infectious Diseases' is a useful reference tool for in-vitro diagnostic associations. Most people will be aware of some of the major developers of in-vitro diagnostics tests for cancer and infectious diseases such as Accugenomics, Inc., Agendia Inc., altona Diagnostics GmbH, Biocept, Inc., bioLytical Laboratories Inc., GeneNews Limited, HiberGene Diagnostics and OvaGene Oncology, Inc. but this major new report looks at all 100 of the top companies. For more information about this report visit http://www.researchandmarkets.com/research/ck84q9/the_top_200


IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, highlights new data on its gold-standard MammaPrint 70-Gene Breast Cancer Recurrence Assay and BluePrint 80-Gene Molecular Subtyping Assay, from three studies presented at the San Antonio Breast Cancer Symposium last week. Researchers from the University of South Florida Morsani College of Medicine reported long-term follow-up data observing 148 patients who were tested with MammaPrint, Genomic Health’s Oncotype DX® and Clarient’s Mammastrat®. The study concluded that the different gene expression-based breast cancer recurrence tests showed discordant results, with only MammaPrint providing a definitive low or high risk outcome. MammaPrint also correctly reassigned a low or high risk result to intermediate Oncotype DX risk scores. The Agendia test was also the best predictor of distant cancer recurrence on identifying 85% of the 13 patients who either died or suffered a distant metastasis as high risk, compared to 54% for Oncotype DX and 62% for Mammostrat.1 The Multi Institutional Neo Adjuvant Therapy MammaPrint Project (MINT) trial demonstrated the predictive value of MammaPrint in further stratifying 183 patients classified as at high risk of their cancer recurring into High1 or High2 risk classes. Coupled with BluePrint, the study found that these MammaPrint high risk sub-groups together could help predict the benefit of chemotherapy.2 The third presentation, a sub-study of the international, prospective, phase III MINDACT trial, published in August 2016, compared molecular subtyping using BluePrint to pathological classification. Molecular subgroups within early-stage breast cancer (such as Luminal A, Luminal B, HER2+, Basel-like) may help to best identify patients for specific treatment approaches. A key conclusion was that molecular subtyping using BluePrint was able to restratify 16% of patients, originally classified pathologically high risk, to a low risk Luminal A-type group, with excellent survival. The study suggests that molecular subtyping by BluePrint is better correlated with outcome than pathological classification.3 The MINDACT trial, which was published in the New England Journal of Medicine, is a unique phase III prospective, randomized, controlled study that provides the highest level of clinical evidence to MammaPrint, above any other genomic assay, for making adjuvant chemotherapy decisions in early-stage breast cancer. It included almost 7,000 patients, across 112 institutions in nine different European countries. William Audeh, MD, Chief Medical Officer at Agendia said: “As the only gene expression-based breast cancer recurrence test supported by Level 1A clinical evidence, it is very good to see the value of MammaPrint, and also BluePrint demonstrated by these new data at this important symposium. The results highlight the benefit of these tests in providing patients with early stage breast cancer, and their physicians, with the confidence to make important, informed treatment decisions. It also demonstrates the potential to further apply our technology to truly individualize the prognosis and the prediction of the best breast cancer treatment, one patient at a time.” For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at KnowYourBreastCancer.com or the corporate site at Agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news. 1Russell S, et al. Long-term follow-up of early stage breast cancer patients with results of MammaPrint, Oncotype DX, and MammoStrat, risk classification assays. Poster presented at San Antonio Breast Cancer Symposium. December 2016; San Antonio, Texas. 2Blumencranz L, et al. Mint trial yields MammaPrint High1/High2 risk classes associated with significant differences in pCR and receptor subtype. Poster presented at San Antonio Breast Cancer Symposium. December 2016; San Antonio, Texas. 3Cardoso F, et al. Can Surrogate Pathological Subtyping Replace Molecular Subtyping? Outcome Results from the MINDACT Trial. Poster presented at San Antonio Breast Cancer Symposium. December 2016; San Antonio, Texas. MammaPrint is a FDA-cleared in vitro diagnostic test, available from FFPE sample, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients' risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine. Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE 70-gene breast cancer recurrence assay as well as BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information, visit www.agendia.com.


Colorectal cancer (CRC) is increasingly being recognized as a heterogeneous disease with distinct molecular subtypes. These subtypes have different biological processes at the basis of their disease and consequently their prognosis and responses to therapy are also different. We have previously developed molecular diagnostic assays using a single platform on routine FFPE tumour biopsies. These assays identify gene expression profiles with distinct prognosis and drug response phenotypes (intrinsic mesenchymal C-type, BRAF mutant-like, and MSI-like). Our overall objective is to develop targeted therapies more effective than the current therapies that do not take advantage of molecular classification of the disease to select patients for therapy. We therefore propose to perform 3 two-stage single arm multi-centre open-label phase II studies based on solid preclinical evidence and a sound scientific rationale for these subgroups of CRC patients: 1) combination of chemotherapy and a TGF-R inhibitor (LY2157299) in patients presenting a C-type signature; 2) vinorelbine in patients with a BRAFm-like signature; and 3) an immunotherapeutic anti-PD-L1 drug (MPDL3280A) in patients with a MSI-like signature. The primary objectives of these studies are to determine the clinical efficacy (progression-free survival as primary endpoint), safety and tolerability of the experimental treatments in these molecularly selected populations. Mutation analysis at the beginning of treatment and monitoring by liquid biopsies might reveal further biomarkers that predict response in retrospective analysis. The project outcomes may have a significant impact in CRC patients with poor-risk prognosis worldwide as 40-50% of them present gene expression profiles matching one of the 3 approaches. Around 40,000 European CRC patients may potentially benefit from the results. Also, these may be translated to other cancer types with equivalent gene expression patterns/deregulated signalling pathways.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2010.2.4.1-8 | Award Amount: 8.20M | Year: 2011

Effective and long term treatment of cancer is now in sight, but will ultimately require an increasingly personalised approach where the right combination of drugs will be administered to the right patients, based on a detailed understanding of their genetic background and their co-associated sensitivity or resistance biomarkers. Efforts are specifically required to identify validated risk and patient-response stratification criteria, which can then be used to rationally develop companion diagnostic assays and more stream-lined clinical trials. COLTHERES will address these key issues by: 1) Molecularly profiling colon cancer patient samples using multiple omics based technologies for co-segregating lesions that could impart resistance to existing and emerging targeted therapies 2) The building and screening of predictive in vitro models based on this data, to enable the rapid and empirical determination of drug resistance biomarkers 3) The use of these models and of the clinical studies to prospectively screen for genes mediating resistance and sensitivity to targeted therapies in CRCs 4) The building of new algorithms to significantly accelerate the design of rational therapies, by integrating more predictive models, assays and biomarkers into all phases of drug discovery; including novel phase-0 (xenopatients) studies 5) The design of innovative and focused biomarker driven phase II trials based on knowledge gathered within the project COLTHERES has assembled a unique consortium, from both academia and industrial SMEs, of world- experts in the areas of; clinical design of innovative biomarker trials and improved therapeutic strategies omics technologies including genomic, transcriptomic, epigenomic and proteomic profiling Functional genomic and disease model-generation Bio-informatics and data analysis, to handle and interrogate the complexity of the data generated through the various approaches


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2010.2.4.1-8 | Award Amount: 7.79M | Year: 2011

Cancer genotyping has identified a number of correlations between mutations in specific genes and responses to targeted anti-cancer drugs, with many mutations occurring in kinases or downstream signaling components. While there are several ongoing large-scale genome re-sequencing studies for the major cancer types, there is no systematic effort to investigate kinase mutations in distinct biological subtypes of these cancers. Here, we will explore the rate of activation of all kinases (the kinome) in two poor-prognosis subtypes of breast cancer for which there are currently no targeted therapies available, namely triple negative (TN) breast tumors lacking the estrogen-, progesterone- and HER2 receptors, constituting 15% of breast cancers, and invasive lobular carcinomas (ILC) of the breast, which represent 10% of breast tumors. Thus, we lack effective targeted therapies for one quarter of all breast cancer patients. In this project, we will identify and validate novel kinase targets for therapy for these TN and ILC subtypes. Kinase targets will be identified via a 4-pronged approach: i) direct re-sequencing of the kinome of 150 TN and 150 ILC tumors, ii) determination of abundance and activation status of kinases in these tumors by reverse phase protein array and tissue microarray technologies, iii) determination of copy number variation by SNP arrays, and iv) mRNA quantitation of the kinome using DNA microarrays. Potential kinase targets for therapy will be validated in preclinical models using RNA interference. Finally, we will perform a phase I/II clinical trial to test the efficacy of a selective PI3K inhibitor in breast cancer. The project will deliver proof-of-concept for novel therapeutic interventions, together with matched molecular diagnostic approaches for patient stratification, for up to 25% of breast cancer patients.


During the last two decades, an increasing number of microarray studies have identified gene-expression profiles that link disease characteristics to patient outcome. However, despite improvements in technology and the clinical relevance of the identified profiles, only a handful of microarray tests are currently available for clinical use. So why have microarrays, regardless of the great application and success within a research setting, not yet been embraced for routine diagnostic use? Besides the strengths of microarray diagnostics, this perspective will outline the important challenges that need to be considered for successful translation of a gene profile into a routine diagnostic test. Finally, some new microarray technologies will be reviewed and an outlook for the future of diagnostic microarrays will be presented. © 2010 Future Science Ltd.


Grant
Agency: Cordis | Branch: H2020 | Program: SME-2 | Phase: PHC-12-2014 | Award Amount: 4.08M | Year: 2015

Agendia NV, a Dutch SME, was founded in 2003 as spin-off from the Netherlands Cancer Institute. They pursue the commercialization of molecular diagnostics using DNA microarray technology for cancer. Agendia aims to be one of the key market players in genomic breast cancer profiling. One of the products Agendia is developing is MammaPrint, a breast cancer recurrence test. This test identifies the risk of recurrence of cancer after surgical treatment, so that the appropriate adjuvant treatment can be selected personalized on the patients tumor characteristics. Breast cancer is the most commom cancer in the world and the principle cause of death of cancer among women worldwide. Currently guidelines recommend that adjuvant therapy is to be considered for all patients with early invasive breast cancer after surgery. However this one size fits all approach leads to a proportion of patients being over- or under treated as the risk of recurrence is difficult to determine. The advancements in molecular diagnostics are starting to improve the prognosis and treatment of breast- and other cancers. MammaPrint is a molecular diagnostic based on analyzing the entire human genome. Agendias solution therefore enables better clinical decisions, reducing over- and under-treatment and therefore leading to better health outcomes and less costs. MammaPrint can be used for all early stage breast cancer patients, which is unique in the field of breast cancer recurrence tests. As MammaPrint will be developed for more accurately identifying which breast cancer patients will gain the most benefit of adjuvant chemotherapy, the potential market for introducing MammaPrint is worldwide. In order to reach this full scale adoption, this project is focused to achieve the last clinical evidence for the clinical utility of this test needed for the uptake in EU and US clinical guidelines and reimbursement arrangements. This uptake is necessary for adoption of MammaPrint by physicians worldwide.


IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, a global molecular diagnostics company that develops and markets genomic diagnostic products, announced that its MammaPrint® breast cancer recurrence test has received further recognition in new guidelines from the National Comprehensive Cancer Network® (NCCN®). These newly issued guidelines affirm that the FDA-cleared MammaPrint test is "clinically validated for prediction of prognosis” of breast cancer in women of all ages and is not limited by estrogen receptor status. Furthermore, this clinical practice document cites published evidence underscoring MammaPrint’s position as the only breast cancer recurrence assay supported by peer-reviewed prospective outcome data. “This expanded support for MammaPrint in the latest NCCN guidelines is further evidence that leading clinicians recognize the unique clinical data behind MammaPrint and the added value it provides physicians and their patients when considering adjuvant chemotherapy treatment,” said Jan Egberts, M.D., the company's CEO. “We are proud of this achievement and are confident it will lead to increased adoption of MammaPrint and its companion BluePrint® molecular subtyping assay.” The NCCN panel took special note of the prospective RASTER study, which concluded that patients classified as Low Risk for recurrence by MammaPrint had a highly favorable outcome. MammaPrint-identified Low Risk patients (85% of whom did not receive adjuvant chemotherapy) had a 97% distant-recurrence-free-interval at five years. “A growing number of cancer experts recognize the contribution that MammaPrint can make, by providing clinically useful information about disease prognosis and risk of recurrence,” said oncologist Neil Barth, M.D., FACP, Agendia’s Chief Medical Officer. “This acknowledgment further supports the emerging realization that accurately establishing a patient’s risk of recurrence, without the limitations seen with other assays, brings significant value to the management of breast cancer patients. The specific mention of the RASTER study confirms the relevance of prospective outcome data when the test was used in a real-world setting.” In contrast to other assays with limited or no FDA clearances, MammaPrint is the only assay cleared for patients of all ages and is not limited by estrogen receptor status. Additionally, unlike other assays, MammaPrint test results do not require that patients complete five years of endocrine therapy. MammaPrint has received six FDA clearances, including most recently for use in formalin-fixed paraffin embedded (FFPE) tissue. Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. For breast cancer, our offerings include MammaPrint as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, and TargetPrint®, an ER/PR/HER2 expression assay. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods. Agendia’s breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome. MammaPrint incorporates a larger panel of genes than any other commercially available test and provides an unambiguous result of “Low vs. High Risk’” for recurrence of a patient’s breast cancer. MammaPrint is available worldwide and has substantial insurance coverage, including Medicare, regional and national insurers in the U.S. encompassing an estimated 200 million lives. Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. It is also a critical partner in the ISPY-2 and the MINDACT trials. For more information, visit www.agendia.com.


IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, a leading molecular diagnostics company that develops and markets genomic diagnostic products, announced at the St. Gallen International Breast Cancer Conference that new guidelines of the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) recommend the MammaPrint® 70-gene breast cancer recurrence assay in Germany’s 2015 guidelines for early-stage invasive breast cancer. "We are extremely pleased that this expert panel has recognized MammaPrint and the substantial body of clinical evidence supporting it," said Jan Egberts, MD, Agendia’s Chief Executive Officer. "MammaPrint is the only breast cancer recurrence assay recommended in the AGO guidelines that is supported by peer-reviewed, prospective five-year outcome data to determine which patients are at low risk of breast cancer recurrence and can therefore safely forego chemotherapy.” At the St. Gallen conference, Agendia sponsored an evening symposia presented by Fatima Cardoso, MD, PhD that highlighted the MINDACT Trial and the U.S. Food & Drug Administration’s (FDA) recent decision to grant MammaPrint its sixth FDA 510(k) clearance. The most recent clearance is for use in formalin-fixed paraffin embedded (FFPE) tissue samples. MammaPrint provides an unambiguous binary Low Risk or High Risk recurrence result. It is part of Agendia’s suite of breast cancer assays that also includes the BluePrint® 80-gene molecular subtyping assay and TargetPrint®, a gene-expression assay. BluePrint provides additional therapy-predictive information, identifying the functional molecular subtype of breast cancer and the associated tumor response to neoadjuvant therapy. Like MammaPrint and TargetPrint, BluePrint is performed on FFPE. It is the most widely available test that uncovers the functional molecular subtype of a woman’s breast cancer. “Agendia’s suite of breast cancer recurrence assays fundamentally changes the conversation at the critical point where treatment decisions are being made,” said Egberts. “While MammaPrint test results eliminate the ambiguity of the intermediate result seen in up to 39% of other tests, functional molecular subtyping by BluePrint provides greater insight into the tumor biology that just isn’t available from most of the other breast cancer recurrence assays on the market.” MammaPrint is available worldwide and has substantial insurance coverage, including Medicare, regional, and national insurers, encompassing an estimated 200 million lives in the U.S. The 14th St. Gallen International Breast Cancer Conference took place in Vienna, Austria, March 18-21, 2015. Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, and TargetPrint®, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay supported by peer-reviewed, published, prospective outcome data. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. It is also a critical partner in the ISPY-2 and the MINDACT trials. For more information, visit www.agendia.com.

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