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"companion diagnostics"

Mikako Ogawa, Hideo Takakura
In vivo molecular imaging is a powerful tool to analyze the human body. Precision medicine is receiving high attention these days, and molecular imaging plays an important role as companion diagnostics in precision medicine. Nuclear imaging with PET or SPECT and optical imaging technologies are used for in vivo molecular imaging. Nuclear imaging is superior for quantitative imaging, and whole-body analysis is possible even for humans. Optical imaging is superior due to its ease of use, and highly targeted specific imaging is possible with activatable agents...
2018: Analytical Sciences: the International Journal of the Japan Society for Analytical Chemistry
Jens Fritsche, Barbara Rakitsch, Franziska Hoffgaard, Michael Römer, Heiko Schuster, Daniel J Kowalewski, Martin Priemer, Vlatka Stos-Zweifel, Helen Hoerzer, Arun Satelli, Annika Sonntag, Valentina Goldfinger, Colette Song, Andrea Mahr, Martina Ott, Oliver Schoor, Toni Weinschenk
Immunotherapy is revolutionizing cancer treatment and has shown success in particular for tumors with a high mutational load. These effects have been linked to neo-antigens derived from patient-specific mutations. To expand efficacious immunotherapy approaches to the vast majority of tumor types and patient populations carrying only a few mutations and maybe not a single presented neoepitope, it is necessary to expand the target space to non-mutated cancer-associated antigens. Mass spectrometry enables the direct and unbiased discovery and selection of tumor-specific HLA peptides that can be used to define targets for immunotherapy...
March 5, 2018: Proteomics
Fangying Xie, Juliana C N Chan, Ronald C W Ma
Diabetes has become a major burden of healthcare expenditure. Diabetes management following a uniform treatment algorithm is often associated with progressive treatment failure and development of diabetic complications. Recent advances in our understanding in the genomic architecture of diabetes and its complications have provided the framework for development of precision medicine to personalize diabetes prevention and management. In this review, we summarized recent advances in the understanding of the genetic basis of diabetes and its complications...
March 2, 2018: Journal of Diabetes Investigation
Verena Haselmann, Christoffer Gebhardt, Ingrid Brechtel, Angelika Duda, Claudia Czerwinski, Antje Sucker, Tim Holland-Letz, Jochen Utikal, Dirk Schadendorf, Michael Neumaier
BACKGROUND: The current standard for determining eligibility of patients with metastatic melanoma for BRAF -targeted therapy is tissue-based testing of BRAF mutations. As patients are rarely rebiopsied, detection in blood might be advantageous by enabling a comprehensive assessment of tumor mutational status in real time and thereby representing a noninvasive biomarker for monitoring BRAF therapy. METHODS: In all, 634 stage I to IV melanoma patients were enrolled at 2 centers, and 1406 plasma samples were prospectively collected...
February 26, 2018: Clinical Chemistry
Sjors G J G In 't Veld, Kim N Duong, Mireille Snel, Anke Witteveen, Inès J Beumer, Leonie J M J Delahaye, Diederik Wehkamp, René Bernards, Annuska M Glas, Sun Tian
Colorectal cancer patients with the BRAF (p.V600E) mutation have poor prognosis in metastatic setting. Personalized treatment options and companion diagnostics are needed to better treat these patients. Previously, we developed a 58-gene signature to characterize the distinct gene expression pattern of BRAF -mutation-like subtype (accuracy 91.1%). Further experiments repurposed drug Vinorelbine as specifically lethal to this BRAF -mutation-like subtype. The aim of this study is to translate this 58-gene signature from a research setting to a robust companion diagnostic that can use formalin-fixed, paraffin-embedded (FFPE) samples to select patients with the BRAF -mutation-like subtype...
November 6, 2017: High Throughput
Emily B Ehlerding, Piotr Grodzinski, Weibo Cai, Christina H Liu
The importance of medical imaging in the diagnosis and monitoring of cancer cannot be overstated. As personalized cancer treatments are gaining popularity, a need for more advanced imaging techniques has grown significantly. Nanoparticles are uniquely suited to fill this void, not only as imaging contrast agents but also as companion diagnostics. This manuscript provides an overview of many ways nanoparticle imaging agents have contributed to cancer imaging, both preclinically and in the clinic, as well as charting future directions in companion diagnostics...
February 20, 2018: ACS Nano
Andrew E Rodda, Bradyn J Parker, Andrew Spencer, Simon R Corrie
Liquid biopsies that analyze circulating tumor DNA (ctDNA) hold great promise in the guidance of clinical treatment for various cancers. However, the innate characteristics of ctDNA make it a difficult target: ctDNA is highly fragmented, and found at very low concentrations, both in absolute terms and relative to wildtype species. Clinically relevant target sequences often differ from the wildtype species by a single DNA base pair. These characteristics make analyzing mutant ctDNA a uniquely difficult process...
February 23, 2018: ACS Sensors
Xiaolong Liang, Jian Sun, Huanwen Wu, Yufeng Luo, Lili Wang, Junliang Lu, Zhiwen Zhang, Junchao Guo, Zhiyong Liang, Tonghua Liu
BACKGROUND: Programmed death ligand 1 (PD-L1) has shown potential as a therapeutic target in numerous solid tumors. Its prognostic significance has also been established in pancreatic ductal adenocarcinoma (PDAC). The present study aimed to explore PD-L1 expression in PDAC cases in a large Chinese cohort using an in vitro diagnostic (IVD) assay to provide further insight into the potential value of programmed cell death protein 1 (PD-1) as a therapeutic target. METHODS: Three hundred seventy-three PDAC patients were retrospectively recruited in this study...
January 17, 2018: Diagnostic Pathology
Yong-Jie Zhou, Guanghua Wang, Yi-Wei Tang
No abstract text is available yet for this article.
January 24, 2018: Emerging Microbes & Infections
Brooke N McKnight, Nerissa T Viola-Villegas
Therapeutic monoclonal antibodies (mAbs) have been used in cancer treatment for 30 years, with around 24 mAb and mAb:drug conjugates approved by the FDA to date. Despite their specificity, efficacy has remained limited, which, in part, derails nascent initiatives towards precision medicine. An image-guided approach to reinforce treatment decisions using immune positron emission tomography (immunoPET) companion diagnostic is warranted. This review provides a general overview of current translational research using Zr-89 immunoPET and opportunities for utilizing and harnessing this tool to its full potential...
January 17, 2018: Journal of Labelled Compounds & Radiopharmaceuticals
(no author information available yet)
The FDA has approved F1CDx, a comprehensive companion diagnostic test that can detect genetic alterations and two genomic signatures in any type of solid tumor. Patients with five common types of advanced cancer can be matched to one of 17 targeted therapies with this single test.
January 16, 2018: Cancer Discovery
Giulia Gallerani, Claudia Cocchi, Martine Bocchini, Filippo Piccinini, Francesco Fabbri
Circulating tumor cells (CTCs) are associated with poor survival in metastatic cancer. Their identification, phenotyping, and genotyping could lead to a better understanding of tumor heterogeneity and thus facilitate the selection of patients for personalized treatment. However, this is hampered because of the rarity of CTCs. We present an innovative approach for sampling a high volume of the patient blood and obtaining information about presence, phenotype, and gene translocation of CTCs. The method combines immunofluorescence staining and DNA fluorescent-in-situ-hybridization (DNA FISH) and is based on a functionalized medical wire...
December 21, 2017: Journal of Visualized Experiments: JoVE
Ariadna Tibau, Consolación Molto, Alberto Ocana, Arnoud J Templeton, Luis P Del Carpio, Joseph C Del Paggio, Agustí Barnadas, Christopher M Booth, Eitan Amir
Background: It is uncertain whether drugs approved by the US Food and Drug Administration (FDA) have clinically meaningful benefit as determined by validated scales such as the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Methods: We searched the Drugs@FDA website for applications of anticancer drugs from January 2006 to December 2016. Study characteristics, outcomes, and regulatory pathways were collected from drug labels and reports of registration trials...
December 13, 2017: Journal of the National Cancer Institute
Olli Carpén, Tuula Helander
Clinical trials aiming at developing targeted drug therapies require the identification of appropriate patient groups, utilizing both clinical information and the biological profile of the disease. The Finnish healthcare system provides exceptional possibilities for utilizing health data in identifying patient groups, planning of clinical sample studies and recruiting patients. Biobanks established at university hospitals together with the regional cancer centers play a central role in collecting biological specimens and attaching health data to the specimens...
2017: Duodecim; Lääketieteellinen Aikakauskirja
Annette S Kim, Angela N Bartley, Julia A Bridge, Suzanne Kamel-Reid, Alexander J Lazar, Neal I Lindeman, Thomas A Long, Jason D Merker, Alex J Rai, David L Rimm, Paul G Rothberg, Patricia Vasalos, Joel T Moncur
Importance: The debate about the role of the Food and Drug Administration (FDA) in the regulation of laboratory-developed tests (LDTs) has focused attention on the analytical performance of all clinical laboratory testing. This study provides data comparing the performance of LDTs and FDA-approved companion diagnostics (FDA-CDs) in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee. Objective: To compare the analytical performance of LDTs and FDA-CDs on well-characterized PT samples and to compare the practice characteristics of laboratories using these assays...
December 14, 2017: JAMA Oncology
Arutha Kulasinghe, Liz Kenny, Chamindie Punyadeera
Immune checkpoint inhibitors have gained traction over the last few years in the treatment of metastatic/recurrent head and neck squamous cell carcinoma (HNSCC) patients. Monoclonal antibodies that block the programmed death 1 (PD-1) receptor and its major ligand, PD-L1, have shown durable responses and low toxicity profiles. There are currently no validated predictive biomarkers to select patients likely to respond to anti-PD-1/PD-L1 therapy to avoid unwanted side effects and to reduce healthcare expenditure...
December 2017: Oral Oncology
Harry Glorikian, Richard Jeremy Warburg, Kelly Moore, Jennifer Malinowski
The development of molecular diagnostics is a complex endeavor, with multiple regulatory pathways to consider and numerous approaches to development and commercialization. Companion diagnostics, devices which are "essential for the safe and effective use of a corresponding drug or diagnostic product" (see U.S. Food & Drug Administration, In Vitro Diagnostics - Companion Diagnostics, U.S. Dept. of Health & Human Services(2016), available at
February 2018: Expert Opinion on Therapeutic Patents
Vanesa G Martinez, Sadhbh O'Neill, Josephine Salimu, Susan Breslin, Aled Clayton, John Crown, Lorraine O'Driscoll
Neuromedin U (NmU) -a neuropeptide belonging to the neuromedin family- plays a substantial role in HER2-positive breast cancer, correlating with increased aggressiveness, resistance to HER2-targeted therapies and overall significantly poorer outcome for patients. However, the mechanism through which it exerts these effects remains unclear. To elucidate this, initially we used HER2-positive breast cancer cells stably over-expressing NmU. These cells and their released extracellular vesicles (EVs) had increased amounts of the immunosuppressive cytokine TGFβ1 and the lymphocyte activation inhibitor PD-L1...
2017: Oncoimmunology
Kristin N Taylor, Ramez N Eskander
Background Ovarian cancer remains the most common lethal gynecologic malignancy. The therapeutic gains with use of traditional cytotoxic chemotherapy in advanced stage disease remain limited, reflecting the need for novel therapies. Poly(ADP-ribose) polymerase (PARP) inhibitors have recently demonstrated a significant therapeutic effect in patients with recurrent, high grade serous ovarian cancer, both in the treatment of existing disease and in prolonging the disease-free interval. Objective The purpose of this article is to discuss PARP inhibitor use in patients with advanced stage ovarian cancer, and to extensively review the existing clinical literature and related patents...
December 3, 2017: Recent Patents on Anti-cancer Drug Discovery
Jan Trøst Jørgensen, Maria Hersom
Nearly 20 years have passed since the US Food and Drug Administration (FDA) approved the first companion diagnostic and today this type of assay governs the use of 21 different anticancer drugs. The regulators deem these assays essential for the safe and effective use of a corresponding therapeutic product. The companion diagnostic assays are important both during the drug development process as well as essential treatment decision tools after the approval of the drugs.
December 2, 2017: Clinical Pharmacology and Therapeutics
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