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https://www.readbyqxmd.com/read/29137388/rapid-and-accurate-detection-of-kras-mutations-in-colorectal-cancers-using-the-isothermal-based-optical-sensor-for-companion-diagnostics
#1
Choong Eun Jin, Seung-Seop Yeom, Bonhan Koo, Tae Yoon Lee, Jeong Hoon Lee, Yong Shin, Seok-Byung Lim
Although KRAS mutational status testing is becoming a companion diagnostic tool for managing patients with colorectal cancer (CRC), there are still several difficulties when analyzing KRAS mutations using the existing assays, particularly with regard to low sensitivity, its time-consuming, and the need for large instruments. We developed a rapid, sensitive, and specific mutation detection assay based on the bio-photonic sensor termed ISAD (isothermal solid-phase amplification/detection), and used it to analyze KRAS gene mutations in human clinical samples...
October 13, 2017: Oncotarget
https://www.readbyqxmd.com/read/29125548/liquid-biopsy-and-therapeutic-targets-present-and-future-issues-in-thoracic-oncology
#2
REVIEW
Paul Hofman
The practice of liquid biopsy (LB) has revolutionized the care of patients with metastatic lung cancer. Many oncologists now use this approach in daily practice, applying precise procedures for the detection of activating or resistance mutations in EGFR. These tests are performed with plasma DNA and have been approved as companion diagnostic test for patients treated with tyrosine kinase inhibitors. ALK is another important target in lung cancer since it leads to treatment of patients who are positive for a rearrangement in ALK identified with tumor tissue...
November 10, 2017: Cancers
https://www.readbyqxmd.com/read/29110507/regulatory-landscapes-for-biomarkers-and-diagnostic-tests-qualification-approval-and-role-in-clinical-practice
#3
William B Mattes, Federico Goodsaid
While the term 'biomarker' is relatively new, the concept is millennia old. However, with the introduction of new technologies to discover potential biomarkers comes the need to assess their utility and veracity for any given use. This is particularly true for the use of biomarkers to support regulatory decisions in medical product development. Hence the US Food and Drug Administration has developed processes for the qualification of biomarkers and other medical product development tools, processes that are underscored by recent legislation (i...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/29105511/the-fda-oncology-center-of-excellence-and-precision-medicine
#4
Kirsten B Goldberg, Gideon M Blumenthal, Amy E McKee, Richard Pazdur
In January 2017, the U.S. Food and Drug Administration (FDA) formally established the Oncology Center of Excellence (OCE) to streamline the development of cancer therapies by uniting experts from FDA product centers to conduct expedited review of drugs, biologics, and devices. In May 2017, the FDA approved a cancer treatment based on a biomarker, without regard to the tumor's site, by granting accelerated approval to pembrolizumab for patients with solid tumors that have the microsatellite instability-high or mismatch repair deficient biomarker...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/29100553/translatability-score-revisited-differentiation-for-distinct-disease-areas
#5
REVIEW
Alexandra Wendler, Martin Wehling
BACKGROUND: Translational science supports successful transition of early biomedical research into human applications. In 2009 a translatability score to assess risk and identify strengths and weaknesses of a given project has been designed and successfully tested in case studies. The score elements, in particular the contributing weight factors, are heterogeneous for different disease areas; therefore, the score was individualized for six areas (cardiovascular, oncology, psychiatric, anti-viral, anti-bacterial/fungal and monogenetic diseases)...
November 3, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/29084031/companion-and-complementary-diagnostics-focus-on-pd-l1-expression-assays-for-pd-1-pd-l1-checkpoint-inhibitors-in-nsclc
#6
Maria Hersom, Jan Trøst Jørgensen
Over the last couple of decades, molecular diagnostics have played an increasing role in drug development. Especially within oncology, more and more drugs are being developed together with a predictive biomarker assay using the drug-diagnostic co-development model. Not only do these assays support the development process but also the use of the drugs after regulatory approval as an important treatment decision tool. When these predictive biomarker assays are linked to a specific drug, they are called companion diagnostics...
October 27, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29083121/in-vitro-label-free-screening-of-chemotherapeutic-drugs-using-raman-micro-spectroscopy-towards-a-new-paradigm-of-spectralomics
#7
REVIEW
Z Farhane, H Nawaz, F Bonnier, H J Byrne
This overview groups some of the recent studies highlighting the potential application of Raman micro-spectroscopy as an analytical technique in preclinical development to predict drug mechanism of action and in clinical application as a companion diagnostic and in personalised therapy due to its capacity to predict cellular resistance and therefore to optimise chemotherapeutic treatment efficacy. Notably, the anthracyclines, Doxorubicin and Actinomycin D, elicit similar spectroscopic signatures of subcellular interaction characteristic of the mode of action of intercalation...
October 30, 2017: Journal of Biophotonics
https://www.readbyqxmd.com/read/29080556/a-new-mutation-independent-approach-to-cancer-therapy-inhibiting-oncogenic-ras-and-myc-by-targeting-mitochondrial-biogenesis
#8
Bela Ozsvari, Federica Sotgia, Michael P Lisanti
Here, we used MCF7 cells as a model system to interrogate how MYC/RAS co-operativity contributes to metabolic flux and stemness in breast cancer cells. We compared the behavior of isogenic MCF7 cell lines transduced with c-Myc or H-Ras (G12V), either individually or in combination. Cancer stem cell (CSC) activity was measured using the mammosphere assay. c-Myc augmented both mammosphere formation and mitochondrial respiration, without any effects on glycolytic flux. In contrast, H-Ras (G12V) synergistically augmented both mammosphere formation and glycolysis, but only in combination with c-Myc, directly demonstrating MYC/RAS co-operativity...
October 27, 2017: Aging
https://www.readbyqxmd.com/read/29071194/prediction-of-anti-cancer-nanotherapy-efficacy-by-imaging
#9
REVIEW
Miles A Miller, Sean Arlauckas, Ralph Weissleder
Anticancer nanotherapeutics have shown mixed results in clinical trials, raising the questions of whether imaging should be used to i) identify patients with a higher likelihood of nanoparticle accumulation, ii) assess nanotherapeutic efficacy before traditional measures show response, and iii) guide adjuvant treatments to enhance therapeutic nanoparticle (TNP) delivery. Here we review the use of a clinically approved MRI nanoparticle (ferumoxytol, FMX) to predict TNP delivery and efficacy. It is becoming increasingly apparent that nanoparticles used for imaging, despite clearly distinct physicochemical properties, often co-localize with TNP in tumors...
2017: Nanotheranostics
https://www.readbyqxmd.com/read/29037984/effect-of-maf-amplification-on-treatment-outcomes-with-adjuvant-zoledronic-acid-in-early-breast-cancer-a-secondary-analysis-of-the-international-open-label-randomised-controlled-phase-3-azure-big-01-04-trial
#10
Robert Coleman, Andrew Hall, Joan Albanell, Andrew Hanby, Richard Bell, David Cameron, David Dodwell, Helen Marshall, Joël Jean-Mairet, Juan-Carlos Tercero, Federico Rojo, Walter Gregory, Roger R Gomis
BACKGROUND: Adjuvant use of bisphosphonates can reduce the incidence of bone metastases in early breast cancer. Recurrence and survival seem to be improved only in postmenopausal patients, but the underlying mechanisms remain unclear. We investigated whether MAF amplification (a biomarker for bone metastasis) in primary tumours could predict the treatment outcomes of adjuvant zoledronic acid. METHODS: The study population included patients enrolled in the international, open-label, randomised, controlled, phase 3 AZURE trial at eligible UK sites who had stage II or III breast cancer and who gave consent for use of their primary tumour samples...
October 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28978152/mitochondrial-markers-predict-recurrence-metastasis-and-tamoxifen-resistance-in-breast-cancer-patients-early-detection-of-treatment-failure-with-companion-diagnostics
#11
Federica Sotgia, Marco Fiorillo, Michael P Lisanti
Here, we used a data-mining and informatics approach to discover new biomarkers of resistance to hormonal therapy in breast cancer. More specifically, we investigated whether nuclear-encoded genes associated with mitochondrial biogenesis can be used to predict tumor recurrence, distant metastasis and treatment failure in high-risk breast cancer patients. Overall, this strategy allowed us to directly provide in silico validation of the prognostic value of these mitochondrial components in large and clinically relevant patient populations, with >15 years of follow-up data...
September 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28978099/mitochondrial-markers-predict-survival-and-progression-in-non-small-cell-lung-cancer-nsclc-patients-use-as-companion-diagnostics
#12
Federica Sotgia, Michael P Lisanti
Here, we used an informatics-based approach to identify novel biomarkers of overall survival and tumor progression in non-small cell lung cancer (NSCLC) patients. We determined whether nuclear-encoded genes associated with mitochondrial biogenesis and function can be used to effectively predict clinical outcome in lung cancer. This strategy allowed us to directly provide in silico validation of the prognostic value of these mitochondrial components in large, clinically-relevant, lung cancer patient populations...
September 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28978020/mitochondrial-biomarkers-predict-tumor-progression-and-poor-overall-survival-in-gastric-cancers-companion-diagnostics-for-personalized-medicine
#13
Federica Sotgia, Michael P Lisanti
Here, we employed a bioinformatics approach to identify novel molecular determinants to predict tumor progression and overall survival in gastric cancer patients. In particular, we directly assessed whether nuclear-derived mRNA species encoding proteins involved in mitochondrial protein translation and OXPHOS are able to successfully predict clinical outcome in gastric cancer. As such, using in silico validation, we have now established the prognostic value of these mitochondrial biomarkers, in a defined population of gastric cancer patients...
September 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28978006/mitochondrial-mrna-transcripts-predict-overall-survival-tumor-recurrence-and-progression-in-serous-ovarian-cancer-companion-diagnostics-for-cancer-therapy
#14
Federica Sotgia, Michael P Lisanti
Here, we performed a systematic analysis to discover new biomarkers of overall survival and tumor progression in ovarian cancer patients. More specifically, we determined whether nuclear-encoded mitochondrial genes related to mitochondrial biogenesis and function are effective in predicting clinical outcome in ovarian cancer. As a consequence, we are able to provide in silico validation of the prognostic value of these mitochondrial markers, in a well-defined population of ovarian cancer patients. Towards this end, we used a group of N=111 ovarian cancer patients (serous type; stage III), with optimal de-bulking...
September 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28968265/diagnostic-utility-of-pd-l1-expression-in-lung-adenocarcinoma-immunohistochemistry-and-rna-in-situ-hybridization
#15
Mohamad Mazen Gafeer, Kareem Hosny Mohammed, Claudia Ormenisan-Gherasim, Fahad Choudhary, Momin T Siddiqui, Cynthia Cohen
BACKGROUND: Programmed death receptor and programmed death ligand (PD-L1) are immunoregulatory proteins. Nonsmall cell lung cancer bypasses the immune system through the induction of protumorigenic immunosuppressive changes. The better understanding of immunology and antitumor immune responses has brought the promising development of novel immunotherapy agents like programmed death receptor checkpoint inhibitors. The aim of this study was to investigate the expression of PD-L1 in lung adenocarcinoma (ADC), comparing 2 different technologies: immunohistochemistry (IHC) by 2 methods versus RNA in situ hybridization (RISH)...
September 29, 2017: Applied Immunohistochemistry & Molecular Morphology: AIMM
https://www.readbyqxmd.com/read/28920579/point-of-care-companion-diagnostic-tests-for-personalizing-psychiatric-medications-fulfilling-an-unmet-clinical-need
#16
Anil S Modak
Over the last decade stable isotope labeled substrates have been used as probes for rapid, point of care, non invasive and user friendly phenotype breath tests to evaluate activity of drug metabolizing enzymes. These diagnostic breath tests can be potentially used as Companion diagnostics (CDx) by physicians to personalize medications especially psychiatric drugs with narrow therapeutic windows, to monitor the progress of disease severity, medication efficacy and to study in vivo the pharmacokinetics of xenobiotics, Several genotype tests have been approved by the FDA over the last 15 years, however, they have not been cleared for use in personalizing medications since they fall woefully short in identifying all non responders to drugs especially for the CYP450 enzymes...
September 18, 2017: Journal of Breath Research
https://www.readbyqxmd.com/read/28854583/non-equivalence-of-anti-m%C3%A3-llerian-hormone-automated-assays-clinical-implications-for-use-as-a-companion-diagnostic-for-individualised-gonadotrophin-dosing
#17
Stamatina Iliodromiti, Barbara Salje, Didier Dewailly, Craig Fairburn, Renato Fanchin, Richard Fleming, Hang Wun Raymond Li, Krzysztof Lukaszuk, Ernest Hung Yu Ng, Pascal Pigny, Teddy Tadros, Joseph van Helden, Ralf Weiskirchen, Scott M Nelson
STUDY QUESTION: Can anti-Müllerian hormone (AMH) automated immunoassays (Elecsys® and Access) be used interchangeably as a companion diagnostic for individualisation of follitropin delta dosing? SUMMARY ANSWER: The Access assay gives systematically higher AMH values than the Elecsys® assay which results in over 29% of women being misclassified to a different follitropin delta dose. WHAT IS KNOWN ALREADY: Follitropin delta is the first gonadotrophin to be licenced with a companion diagnostic, the Roche Elecsys® AMH Plus assay...
August 1, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28844206/gestational-diabetes-mellitus-right-person-right-treatment-right-time
#18
Robert S Lindsay, Sharon T Mackin, Scott M Nelson
BACKGROUND: Personalised treatment that is uniquely tailored to an individual's phenotype has become a key goal of clinical and pharmaceutical development across many, particularly chronic, diseases. For type 2 diabetes, the importance of the underlying clinical heterogeneity of the condition is emphasised and a range of treatments are now available, with personalised approaches being developed. While a close connection between risk factors for type 2 diabetes and gestational diabetes has long been acknowledged, stratification of screening, treatment and obstetric intervention remains in its infancy...
August 28, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28838392/detection-of-epidermal-growth-factor-receptor-gene-t790m-mutation-in-cytology-samples-using-the-cobas-%C3%A2-egfr-mutation-test
#19
Miyako Satouchi, Hiroshi Tanaka, Hiroshige Yoshioka, Tadasuke Shimokawaji, Keiko Mizuno, Koji Takeda, Ichiro Yoshino, Takashi Seto, Takayasu Kurata, Naoki Tashiro, Koichi Hagiwara
OBJECTIVE: Detection of epidermal growth factor receptor (EGFR) gene mutations is essential in deciding therapeutic strategy in non-small cell lung cancer (NSCLC) patients at initial diagnosis. Moreover, in EGFR mutation-positive (EGFRm) NSCLC patients, re-biopsy at disease progression to clarify resistance mechanisms is also important. However, collecting histology samples is often difficult because of inaccessibility and invasiveness. In some cases, only cytology samples can be collected, and studies have reported that cytology samples are appropriate for EGFR gene mutation testing...
September 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28825794/nanofitin-as-a-new-molecular-imaging-agent-for-the-diagnosis-of-epidermal-growth-factor-receptor-over-expressing-tumors
#20
Marine Goux, Guillaume Becker, Harmony Gorré, Sylvestre Dammicco, Ariane Desselle, Dominique Egrise, Natacha Leroi, François Lallemand, Mohamed Ali Bahri, Gilles Doumont, Alain Plenevaux, Mathieu Cinier, André Luxen
Epidermal growth-factor receptor (EGFR) is involved in cell growth and proliferation and is over-expressed in malignant tissues. Although anti-EGFR-based immunotherapy became a standard of care for patients with EGFR-positive tumors, this strategy of addressing cancer tumors by targeting EGFR with monoclonal antibodies is less-developed for patient diagnostic and monitoring. Indeed, antibodies exhibit a slow blood clearance, which is detrimental for positron emission tomography (PET) imaging. New molecular probes are proposed to overcome such limitations for patient monitoring, making use of low-molecular-weight protein scaffolds as alternatives to antibodies, such as Nanofitins with better pharmacokinetic profiles...
September 20, 2017: Bioconjugate Chemistry
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