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https://www.readbyqxmd.com/read/29760435/biomarkers-as-drug-development-tools-discovery-validation-qualification-and-use
#1
REVIEW
Virginia B Kraus
The 21st Century Cures Act, approved in the USA in December 2016, has encouraged the establishment of the national Precision Medicine Initiative and the augmentation of efforts to address disease prevention, diagnosis and treatment on the basis of a molecular understanding of disease. The Act adopts into law the formal process, developed by the FDA, of qualification of drug development tools, including biomarkers and clinical outcome assessments, to increase the efficiency of clinical trials and encourage an era of molecular medicine...
May 14, 2018: Nature Reviews. Rheumatology
https://www.readbyqxmd.com/read/29758342/next-generation-sequencing-in-drug-development-target-identification-and-genetically-stratified-clinical-trials
#2
REVIEW
Abolfazl Doostparast Torshizi, Kai Wang
Next-generation sequencing (NGS) enabled high-throughput analysis of genotype-phenotype relationships on human populations, ushering in a new era of genetics-informed drug development. The year 2017 was remarkable, with the first FDA-approved gene therapy for cancer (Kymriah™) and for inherited diseases (LUXTURNA™), the first multiplex NGS panel for companion diagnostics (MSK-IMPACT™) and the first drug targeting a genetic signature rather than a disease (Keytruda® ). We envision that population-scale NGS with paired electronic health records (EHRs) will become a routine measure in the drug development process for the identification of novel drug targets, and that genetically stratified clinical trials could be widely adopted to improve power in precision-medicine-guided drug development...
May 11, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29732534/epigenetic-loss-of-heparan-sulfate-3-o-sulfation-sensitizes-ovarian-carcinoma-to-oncogenic-signals-and-predicts-prognosis
#3
Rui-Lan Huang, Hsiang-Ju Chen, Lin-Yu Chen, Tai-Kuang Chao, Wei-Yu Lin, Phui-Ly Liew, Po-Hsuan Su, Yu-Chun Weng, Yu-Chi Wang, Chi-Chun Liao, Yaw-Wen Hsu, Hui- Chen Wang, Hung-Cheng Lai
Precision medicine requires markers for therapeutic guidance. The purpose of this study was to determine whether epithelial ovarian cancer (EOC) epigenetics can lead to the identification of biomarkers for precision medicine. Through integrative methylomics, we discovered and validated the epigenetic signature of NEFH and HS3ST2 as an independent prognostic factor for type II EOC in our dataset (n = 84), two independent methylomics datasets (total n = 467). Integrated transcriptomics dataset (n = 1147) and tissue microarrays (n = 54) of HS3ST2 also related to high-methylation statuses and the EOC prognosis...
May 7, 2018: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/29721081/companion-diagnostic-64-cu-liposome-positron-emission-tomography-enables-characterization-of-drug-delivery-to-tumors-and-predicts-response-to-cancer-nanomedicines
#4
Helen Lee, Daniel Gaddy, Manuela Ventura, Nicholas Bernards, Raquel de Souza, Dmitri Kirpotin, Thomas Wickham, Jonathan Fitzgerald, Jinzi Zheng, Bart S Hendriks
Deposition of liposomal drugs into solid tumors is a potentially rate-limiting step for drug delivery and has substantial variability that may influence probability of response. Tumor deposition is a shared mechanism for liposomal therapeutics such that a single companion diagnostic agent may have utility in predicting response to multiple nanomedicines. Methods: We describe the development, characterization and preclinical proof-of-concept of the positron emission tomography (PET) agent, MM-DX-929, a drug-free untargeted 100 nm PEGylated liposome stably entrapping a chelated complex of 4-DEAP-ATSC and 64 Cu (copper-64)...
2018: Theranostics
https://www.readbyqxmd.com/read/29713694/how-imaldi-can-improve-clinical-diagnostics
#5
R Popp, M Basik, A Spatz, G Batist, R P Zahedi, C H Borchers
Protein mass spectrometry (MS) is an indispensable tool to detect molecular signatures that can be associated with cellular dysregulation and disease. Despite its huge success in the life sciences, where it has led to novel insights into disease mechanisms and the identification of potential protein biomarkers, protein MS is rarely used for clinical protein assays. While conventional matrix-assisted laser desorption/ionization (MALDI) MS is not compatible with complex samples, liquid chromatography-MS (LC-MS)-based assays may be too complex and may lack the robustness and ease of automation required for routine use in the clinic...
May 1, 2018: Analyst
https://www.readbyqxmd.com/read/29703766/immuno-oncology-biomarkers-for-gastric-and-gastroesophageal-junction-adenocarcinoma-why-pd-l1-testing-may-not-be-enough
#6
Benjamin A Weinberg, Joanne Xiu, Jimmy J Hwang, Anthony F Shields, Mohamed E Salem, John L Marshall
PURPOSE: The treatment of patients with advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinomas has been transformed by the U.S. Food and Drug Administration approval of pembrolizumab. Tumor and adjacent tissue must stain positively for the programmed cell death ligand 1 (PD-L1) protein by companion diagnostic testing. However, some patients with PD-L1-negative tumors also benefit from pembrolizumab. High microsatellite instability (MSI) and tumor mutational load (TML) are positive predictive biomarkers for immune checkpoint inhibition (ICI) in other tumors...
April 27, 2018: Oncologist
https://www.readbyqxmd.com/read/29660160/digital-image-analysis-improves-precision-of-programmed-death-ligand-1-pd-l1-scoring-in-cutaneous-melanoma
#7
Viktor H Koelzer, Aline Gisler, Jonathan C Hanhart, Johannes Griss, Stephan N Wagner, Niels Willi, Gieri Cathomas, Melanie Sachs, Werner Kempf, Daniela S Thommen, Kirsten D Mertz
AIMS: Immune checkpoint inhibitors have become a successful treatment in metastatic melanoma. The high response rates in a subset of patients suggest that a sensitive companion diagnostic test is required. The predictive value of programmed death ligand 1 (PD-L1) staining in melanoma has been questioned due to inconsistent correlation with clinical outcome. Whether this is due to predictive irrelevance of PD-L1 expression or inaccurate assessment techniques remains unclear. The aim of this study was to develop a standardized digital protocol for the assessment of PD-L1 staining in melanoma and to compare the output data and reproducibility to conventional assessment by expert pathologists...
April 16, 2018: Histopathology
https://www.readbyqxmd.com/read/29626418/bergamot-natural-products-eradicate-cancer-stem-cells-cscs-by-targeting-mevalonate-rho-gdi-signalling-and-mitochondrial-metabolism
#8
Marco Fiorillo, Maria Peiris-Pagès, Rosa Sanchez-Alvarez, Lucia Bartella, Leonardo Di Donna, Vincenza Dolce, Giovanni Sindona, Federica Sotgia, Anna Rita Cappello, Michael P Lisanti
Here, we show that a 2:1 mixture of Brutieridin and Melitidin, termed "BMF", has a statin-like properties, which blocks the action of the rate-limiting enzyme for mevalonate biosynthesis, namely HMGR (3-hydroxy-3-methylglutaryl-CoA-reductase). Moreover, our results indicate that BMF functionally inhibits several key characteristics of CSCs. More specifically, BMF effectively i) reduced ALDH activity, ii) blocked mammosphere formation and iii) inhibited the activation of CSC-associated signalling pathways (STAT1/3, Notch and Wnt/beta-catenin) targeting Rho-GDI-signalling...
April 4, 2018: Biochimica et Biophysica Acta
https://www.readbyqxmd.com/read/29615401/cms-to-cover-ngs-companion-diagnostics
#9
(no author information available yet)
The Centers for Medicare & Medicaid Services recently announced that next-generation sequencing-based companion diagnostics will be covered for beneficiaries with advanced cancer. This announcement takes coverage decisions out of the hands of local contractors, providing more uniform access to such tests.
April 3, 2018: Cancer Discovery
https://www.readbyqxmd.com/read/29600239/clinical-outcome-study-of-crizotinib-in-immunohistochemistry-proven-echinoderm-microtubule-associated-protein-like-4-anaplastic-lymphoma-kinase-fusion-gene-among-indian-patients-with-adenocarcinoma-lung
#10
Ullas Batra, Mohit Aggarwal, Parveen Jain, Pankaj Goyal, Abhishek Yadav, Udip Maheshwari, Anurag Mehta
Aims: The anaplastic lymphoma kinase (ALK) Break Apart FISH Probe Kit and Ventana anti-ALK (D5F3) CDx immunohistochemistry (IHC) assay are the Food and Drug Administration-approved companion diagnostic for targeted therapy with the ALK inhibitor crizotinib in lung cancers. The aim of this study was to assess the efficacy and safety of twice daily crizotinib tablet (250 mg) in IHC-proven echinoderm microtubule-associated protein-like 4 (EML4)-ALK fusion gene among Indian patients with adenocarcinoma lung in the routine clinical practice...
January 2018: South Asian Journal of Cancer
https://www.readbyqxmd.com/read/29579404/analytical-chemistry-in-the-regulatory-science-of-medical-devices
#11
Yi Wang, Allan Guan, Samanthi Wickramasekara, K Scott Phillips
In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e...
March 26, 2018: Annual Review of Analytical Chemistry
https://www.readbyqxmd.com/read/29572000/pd-l1-expression-in-lung-adenocarcinoma-harboring-egfr-mutations-or-alk-rearrangements
#12
Yasuto Yoneshima, Kayo Ijichi, Satoshi Anai, Keiichi Ota, Kohei Otsubo, Eiji Iwama, Kentaro Tanaka, Yoshinao Oda, Yoichi Nakanishi, Isamu Okamoto
OBJECTIVES: Expression of programmed cell death-ligand 1 (PD-L1) has been associated with clinical outcome of programmed cell death-1 (PD-1) pathway blockade in non-small cell lung cancer (NSCLC). The PD-L1 IHC 22C3 pharmDx assay, the only companion diagnostic for pembrolizumab therapy, has revealed that ∼30% of all NSCLCs express PD-L1 at a high level. The frequency of high PD-L1 expression in NSCLCs with known driver oncogenes has remained unclear, however. MATERIALS AND METHODS: We retrospectively evaluated PD-L1 expression with the 22C3 assay in tumor tissue of 80 lung adenocarcinoma patients including 71 with EGFR mutations and 9 with ALK rearrangements, all of whom were treated with corresponding tyrosine kinase inhibitors (TKIs)...
April 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29571563/-pd-l1-testing-in-non-small-cell-lung-carcinoma-guidelines-from-the-pattern-group-of-thoracic-pathologists
#13
Sylvie Lantuejoul, Julien Adam, Nicolas Girard, Mickael Duruisseaux, Audrey Mansuet-Lupo, Aurélie Cazes, Isabelle Rouquette, Laure Gibault, Stéphane Garcia, Martine Antoine, Jean Michael Vignaud, Françoise Galateau-Sallé, Christine Sagan, Cécile Badoual, Frédérique Penault-Llorca, Diane Damotte
Lung cancer is the leading cause of cancer death in France with low response rates to conventional chemotherapy. Nevertheless, new therapies have emerged recently, among which PD1 immune checkpoint inhibitors (ICI), such as nivolumab (OPDIVO® , Bristol-Myers Squibb) and pembrolizumab (KEYTRUDA® , Merck & Co), or PD-L1 ICI, such as atezolizumab (TECENTRIQ® , Genentech), durvalumab (IMFINZI® , Astra-Zeneca), and avelumab (BAVENCIO® , EMD Serono). The prescription of pembrolizumab for advanced stages non-small cell lung carcinoma (NSCLC) patients requires the demonstration of PD-L1 expression by tumor cells by immunohistochemistry (IHC) (minimum of 50% of positive tumor cells is required for first-line setting, and of 1% for second-line and beyond) and PD-L1 assay is now considered as a companion diagnostic tool for this drug...
March 20, 2018: Annales de Pathologie
https://www.readbyqxmd.com/read/29563201/evaluation-of-fluorescence-microsphere-immunoassay-for-the-detection-of-antibodies-to-rift-valley-fever-nucleocapsid-protein-and-glycoproteins
#14
I K Ragan, A S Davis, D S McVey, J A Richt, R R Rowland, W C Wilson
Rift Valley Fever virus (RVFV) is a mosquito-borne zoonotic virus that infects ruminants including cattle, sheep, goats, camels and buffalo. Multiplexing diagnostic assays that can simultaneously detect antibodies against multiple RVFV antigens offer a high throughput test for disease surveillance and vaccine evaluations. We describe the improvement and evaluation of a previously developed fluorescence microsphere immunoassay (FMIA) for the detection of IgG and IgM antibodies against the RVFV glycoproteins (Gn) and the immunogenic nucleocapsid protein (Np)...
March 21, 2018: Journal of Clinical Microbiology
https://www.readbyqxmd.com/read/29526893/in-vivo-molecular-imaging-for-biomedical-analysis-and-therapies
#15
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
https://www.readbyqxmd.com/read/29505699/translating-immunopeptidomics-to-immunotherapy-decision-making-for-patient-and-personalized-target-selection
#16
Jens Fritsche, Barbara Rakitsch, Franziska Hoffgaard, Michael Römer, Heiko Schuster, Daniel J Kowalewski, Martin Priemer, Vlatka Stos-Zweifel, Helen Hörzer, 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 neoantigens 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 human leukocyte antigen (HLA) peptides that can be used to define targets for immunotherapy...
March 5, 2018: Proteomics
https://www.readbyqxmd.com/read/29499103/precision-medicine-in-diabetes-prevention-classification-and-management
#17
REVIEW
Fangying Xie, Juliana Cn Chan, Ronald Cw 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 of the genomic architecture of diabetes and its complications have provided the framework for development of precision medicine to personalize diabetes prevention and management. In the present review, we summarized recent advances in the understanding of the genetic basis of diabetes and its complications...
March 2, 2018: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/29483107/liquid-profiling-of-circulating-tumor-dna-in-plasma-of-melanoma-patients-for-companion-diagnostics-and-monitoring-of-braf-inhibitor-therapy
#18
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...
May 2018: Clinical Chemistry
https://www.readbyqxmd.com/read/29479053/a-computational-workflow-translates-a-58-gene-signature-to-a-formalin-fixed-paraffin-embedded-sample-based-companion-diagnostic-for-personalized-treatment-of-the-braf-mutation-like-subtype-of-colorectal-cancers
#19
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
https://www.readbyqxmd.com/read/29462554/big-potential-from-small-agents-nanoparticles-for-imaging-based-companion-diagnostics
#20
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 review 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...
March 27, 2018: ACS Nano
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