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"companion diagnostics"

Samata Kakkad, Jiangyang Zhang, Alireza Akhbardeh, Desmond Jacob, Balaji Krishnamachary, Meiyappan Solaiyappan, Michael A Jacobs, Venu Raman, Dieter Leibfritz, Kristine Glunde, Zaver M Bhujwalla
Collagen 1 (Col1) fibers play an important role in tumor interstitial macromolecular transport and cancer cell dissemination. Our goal was to understand the influence of Col1 fibers on water diffusion, and to examine the potential of using noninvasive diffusion tensor imaging (DTI) to indirectly detect Col1 fibers in breast lesions. We previously observed, in human MDA-MB-231 breast cancer xenografts engineered to fluoresce under hypoxia, relatively low amounts of Col1 fibers in fluorescent hypoxic regions...
October 2016: Neoplasia: An International Journal for Oncology Research
Matthieu Hanf, David Chiron, Sophie de Visme, Cyrille Touzeau, Hervé Maisonneuve, Henry Jardel, Catherine Pellat-Deceunynck, Martine Amiot, Steven le Gouill
BACKGROUND: Mantle Cell Lymphoma (MCL) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MCL is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MCL therapies and about associated predictors remains poor. The REFRACT-LYMA Cohort, a multicenter prospective cohort of patients with MCL, is set up to address this limitation...
October 14, 2016: BMC Cancer
Emily Han-Chung Hsiue, Jih-Hsiang Lee, Chia-Chi Lin, James Chih-Hsin Yang
Gefitinib is recently approved by the US Food and Drug Administration as a first-line treatment for non-small cell lung cancer (NSCLC) patients harboring EGFR mutations. The therascreen® EGFR RGQ PCR Kit is approved as a companion diagnostic to select patients with EGFR exon 19 deletions and L858R mutation for treatment with gefitinib. Areas covered: This article reviews the methods for detecting EGFR mutations, the technology and indication of the therascreen® kit, and the clinical utility of the assay in phase 3 and phase 4 clinical trials...
October 13, 2016: Expert Review of Molecular Diagnostics
Bernd Mayer, Andreas Heinzel, Arno Lukas, Paul Perco
BACKGROUND: Productivity in drug R&D continues seeing significant attrition in clinical stage testing. Approval of new molecular entities proceeds with slow pace specifically when it comes to chronic, age-related diseases, calling for new conceptual approaches, methodological implementation and organizational adoption in drug development. METHODS: Detailed phenotyping of disease presentation together with comprehensive representation of drug mechanism of action is considered as a path forward, and a big data spectrum has become available covering behavioral, clinical and molecular characteristics, the latter combining reductionist and explorative strategies...
October 6, 2016: Current Pharmaceutical Design
Jerzy Adamski
Metabolomics is instrumental in the analysis of disease mechanisms and biomarkers of disease. The human metabolome is influenced by genetics and environmental interactions and reveals characteristic signatures of disease. Population studies with metabolomics require special study designs and care needs to be taken with pre-analytics. Gas chromatography coupled to mass spectrometry, liquid chromatography coupled to mass spectrometry or NMR are popular techniques used for metabolomic analyses in human cohorts...
October 6, 2016: Diabetologia
Nadja Apelt, Jochen Hubertus, Doris Mayr, Norbert Graf, Rhoikos Furtwängler, Dietrich Von Schweinitz, Roland Kappler
Wilms tumor (WT) is the most common pediatric renal malignancy. A recent ontogenic model suggests that undifferentiated tumor state, and hence poor prognosis, in WT is determined by stabilization of β-catenin in the nucleus. Forkhead box M1 (FOXM1) is a downstream component of the Wnt pathway and promotes nuclear localization of β-catenin. As elevation of FOXM1 gene expression is prognostic in various types of malignancy, we hypothesized that high FOXM1 expression in WT is associated with undifferentiated histology and thus poor prognosis...
October 2016: Oncology Letters
Eeva Auvinen
Virology is probably the most rapidly developing field within clinical laboratory medicine. Adequate diagnostic methods exist for the diagnostics of most acute viral infections. However, emergence of pathogenic viruses or virus strains and new disease associations of known viruses require the establishment of new diagnostic methods, sometimes very rapidly. In the field of chronic or persistent viral diseases, particularly those involving potential of malignant or fatal development, there is a constant need for improved differential diagnostics, monitoring, prognosis and risk assessment...
September 28, 2016: Molecular Diagnosis & Therapy
Raphael B Stricker, Lorraine Johnson
Lyme disease caused by the spirochete Borrelia burgdorferi has become a major worldwide epidemic. Recent studies based on Big Data registries show that >300,000 people are diagnosed with Lyme disease each year in the USA, and up to two-thirds of individuals infected with B. burgdorferi will fail conventional 30-year-old antibiotic therapy for Lyme disease. In addition, animal and human evidence suggests that sexual transmission of the Lyme spirochete may occur. Improved companion diagnostic tests for Lyme disease need to be implemented, and novel treatment approaches are urgently needed to combat the epidemic...
2016: Infection and Drug Resistance
Tzahi Neuman, Michal London, Juliane Kania-Almog, Anna Litvin, Yaniv Zohar, Ludmila Fridel, Judith Sandbank, Iris Barshak, Gilad W Vainer
INTRODUCTION: Immunotherapy is a novel treatment for lung cancer. Pembrolizumab (Merck Sharp and Dohme, Kenilworth, NJ) is a monoclonal antibody against programmed cell death 1 that has been approved for use with NSCLC together with a companion diagnostic by Dako (Carpinteria, CA). Ventana's BenchMark XT (Ventana Medical Systems, Tucson, AZ) is a widely used immunohistochemical (IHC) platform. However, data on its reliability and reproducibility with the 22C3 antibody are scant. METHODS: We performed a comprehensive calibration of 22C3 programmed cell death ligand 1 (PD-L1) staining on the BenchMark XT platform using Dako's prediluted 22C3 anti-PD-L1 primary antibody with two of Ventana's detection systems...
September 21, 2016: Journal of Thoracic Oncology
Stephen P Arnerić, Richard Batrla-Utermann, Laurel Beckett, Tobias Bittner, Kaj Blennow, Leslie Carter, Robert Dean, Sebastiaan Engelborghs, Just Genius, Mark Forrest Gordon, Janice Hitchcock, June Kaplow, Johan Luthman, Richard Meibach, David Raunig, Klaus Romero, Mahesh N Samtani, Mary Savage, Leslie Shaw, Diane Stephenson, Robert M Umek, Hugo Vanderstichele, Brian Willis, Susan Yule
Alzheimer's disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implementation of novel, objectively measured biomarkers for AD that would aid selection of the appropriate subpopulation of patients in clinical trials, and presumably, improve the likelihood of successfully evaluating innovative treatment options...
September 21, 2016: Journal of Alzheimer's Disease: JAD
Harald Enzmann, Ralf Meyer, Karl Broich
The new European regulation for in vitro diagnostics (IVD) divides the certification of IVD including companion diagnostics (CDx) by notified bodies (NB) from the market authorization of medicines. With the new regulation, CDx will require conformity assessment which is expected to include clinical evidence by NB. This is a significant change from the current situation: until now most IVD have been certified based on their manufacturers' assessment. For one medicine assessed by the EMA, certification of several different CDx by different NB is possible...
September 23, 2016: Biomarkers in Medicine
Yunqi Bu, Xiao-Hua Zhou
Personalized medicine is an area of growing attention in medical research and practice. A market-ready companion diagnostic test (CDx) is used in personalized medicine for identifying the best treatment for an individual patient. Unfortunately, development of CDx may lag behind the development of the drug, and consequently we use a clinical trial assay (CTA) to enroll patients into the drug pivotal clinical trial instead. Thus, when CDx becomes available, a bridging study will be required to assess the drug efficacy in the CDx intended use (CDx IU) population...
September 20, 2016: Journal of Biopharmaceutical Statistics
Hisae Iinuma, Noriyuki Matsutani, Hirofumi Uehara, Masafumi Kawamura
The superior therapeutic effects of antibodies targeting immune checkpoints have been reported in the treatment of various cancers including non-small cell lung cancer(NSCLC)and malignant melanoma. However, the risk of reactivity against selfantigens and the high prices of these drugs are major concerns. Previously, PD-L1 protein expression and the number of infiltrating T cells in tumor tissues were investigated by immunohistochemical staining, as biomarkers for therapeutic anti-PD- 1 antibodies. However, further research into the clinical significance of PD-L1 expression in tumor tissues is still required...
September 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Fang Zhou, Andre L Moreira
Context .- In the burgeoning era of molecular genomics, immunoperoxidase (IPOX) testing grows increasingly relevant as an efficient and effective molecular screening tool. Patients with lung carcinoma may especially benefit from the use of IPOX because most lung carcinomas are inoperable at diagnosis and only diagnosed by small tissue biopsy or fine-needle sampling. When such small specimens are at times inadequate for molecular testing, positive IPOX results still provide actionable information. Objective ...
September 2, 2016: Archives of Pathology & Laboratory Medicine
Marisa Dolled-Filhart, Charlotte Roach, Grant Toland, Dave Stanforth, Malinka Jansson, Gregory M Lubiniecki, Gary Ponto, Kenneth Emancipator
Context .- Programmed death ligand-1 (PD-L1) expression by tumors may enable them to avoid immunosurveillance. Objective .- To develop a PD-L1 immunohistochemical assay using the 22C3 anti-PD-L1 murine monoclonal antibody on the Dako platform as a possible companion diagnostic for pembrolizumab in patients with non-small cell lung cancer. Design .- Tumor samples from 146 patients with non-small cell lung cancer treated with pembrolizumab in KEYNOTE-001 and for whom response data were available were scored according to their staining intensity by a single pathologist using 4 methods: percentage of tumor cells staining at any intensity (PS1), moderate/strong intensity (PS2), strong intensity (PS3), and H-score (PS1 + PS2 + PS3)...
August 23, 2016: Archives of Pathology & Laboratory Medicine
Stefan Holdenrieder
Blood-based biomarkers are valuable diagnostic tools for the management of lung cancer patients. They support not only differential diagnosis and histological subtyping, but are also applied for estimation of prognosis, stratification for specific therapies, monitoring of therapy response, surveillance monitoring and early detection of residual or progressive disease. Early diagnosis of lung cancer in high risk populations (screening) is a promising future indication but poses high medical and economic challenges to marker performance...
2016: Scandinavian Journal of Clinical and Laboratory Investigation. Supplementum
Richard Barker
Precision medicine is now recognized globally as a major new era in medicine. It is being driven by advances in genomics and other 'omics' but also by the desire on the part of both health systems and governments to offer more targeted and cost-effective care. However, it faces a number of challenges, from the economics of developing more expensive companion diagnostics to the need to educate patients and the public on the advantages for them. New models of both R&D and care delivery are needed to capture the scientific, clinical and economic benefits of precision medicine...
2016: Scandinavian Journal of Clinical and Laboratory Investigation. Supplementum
Tinghui Yu, Qin Li, Gerry Gray, Lilly Q Yue
Due to rapid technological development, innovations in diagnostic devices are proceeding at an extremely fast pace. Accordingly, the needs for adopting innovative statistical methods have emerged in the evaluation of diagnostic devices. Statisticians in the Center for Devices and Radiological Health at the Food and Drug Administration have provided leadership in implementing statistical innovations. The innovations discussed in this article include: the adoption of bootstrap and Jackknife methods, the implementation of appropriate multiple reader multiple case study design, the application of robustness analyses for missing data, and the development of study designs and data analyses for companion diagnostics...
August 19, 2016: Journal of Biopharmaceutical Statistics
Kihoon Cha, Yi Li, Gwan-Su Yi
BACKGROUND: Tyrosine kinase inhibitor (TKI)-based therapy is a recommended treatment for patients with chronic myeloid leukemia (CML). However, a considerable group of CML patients do not respond well to the TKI therapy. Challenging to overcome this problem, we tried to discover molecular signatures in gene expression profiles to discriminate the responders and non-responders of TKI therapy. METHODS: We collected three microarray datasets of CML patients having total 73 responders and 38 non-responders...
2016: BMC Medical Genomics
Claud Grigg, Naiyer A Rizvi
Research in cancer immunology is currently accelerating following a series of cancer immunotherapy breakthroughs during the last 5 years. Various monoclonal antibodies which block the interaction between checkpoint molecules PD-1 on immune cells and PD-L1 on cancer cells have been used to successfully treat non-small cell lung cancer (NSCLC), including some durable responses lasting years. Two drugs, nivolumab and pembrolizumab, are now FDA approved for use in certain patients who have failed or progressed on platinum-based or targeted therapies while agents targeting PD-L1, atezolizumab and durvalumab, are approaching the final stages of clinical testing...
2016: Journal for Immunotherapy of Cancer
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