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Expert Review of Molecular Diagnostics

Benjamin J DiPardo, Paul Winograd, Colin M Court, James S Tomlinson
Pancreatic cancer (PC) is a highly lethal disease, in part because of early metastasis, late diagnosis, and limited treatment options. Circulating tumor cells (CTCs) are cancer cells that have achieved the metastatic step of intravasation, and are thus a unique source of biomarkers with potential applications in the staging, prognostication, and treatment of PC. Areas covered: This review describes the use of CTCs in PC, including isolation methods, the significance of CTC enumeration, and studies examining phenotypic and molecular characteristics of CTCs...
August 11, 2018: Expert Review of Molecular Diagnostics
Mitchell R McGill, Hartmut Jaeschke
The difficulty of understanding and diagnosing drug-induced liver injury (DILI) has led to proliferation of serum and genetic biomarkers. Many applications of these biomarkers have been proposed, including investigation of mechanisms, prediction of DILI during early trials or before initiation of therapy in patients, and diagnosis of DILI during therapy. Areas covered: We review the definition and categories of DILI, describe recent developments in DILI biomarker development, and provide guidance for future directions in DILI biomarker research...
August 6, 2018: Expert Review of Molecular Diagnostics
Giuseppe Gaipa, Chiara Buracchi, A Biondi
Flow cytometric quantification of minimal residual disease (MRD) in acute leukemia (AL) represents an indispensable tool to guide modern therapeutic protocols toward a precision medicine approach, being a powerful predictor of the overall response to treatment. This review covers the most challenging aspects and developments of this method, aiming at supporting further its implementation in clinical practices. Area covered: Flow cytometric MRD is based on the discrimination of leukemia cells from their physiological counterparts by the recognition of the leukemia-associated immunophenotypes...
August 2, 2018: Expert Review of Molecular Diagnostics
Natasha Gous, Jeff Takle, Aaron Oppenheimer, Alan Schooley
In pursuit of the 90-90-90 goals, emphasis has been placed on accelerating centralized-laboratory HIV viral load testing of a population that is largely rural and decentralized. Successful outcome requires effective specimen transport, laboratory testing, and results delivery. This paper focuses on the methods currently employed for results delivery. New innovations in this area are yielding mixed results; we analyze different approaches and estimate the impact of each on achieving the third '90.' Areas covered: Strategies employing electronic or mobile health platforms, such as online portals, SMS, and SMS printers are showing potential to deliver results in significantly improved turnaround times but are not without challenges...
July 30, 2018: Expert Review of Molecular Diagnostics
Pedro V Baptista
An update on the uses and applications of the non-cross-linking (NCL) hybridization assay based on the spectral modulation of gold nanoparticles (AuNPs) are presented, emphasizing DNA and RNA detection. Areas covered: Nanotechnology is strongly impacting the way we address diagnostics and therapeutics. In fact, nanoscale devices and particles have been used in a variety of platforms for improved biosensing and, more interestingly, for molecular diagnostics. AuNPs have been used in a great diversity of DNA and RNA detection strategies that are based on their nanoscale properties...
July 27, 2018: Expert Review of Molecular Diagnostics
Giorgio Gallinella
Parvovirus B19 (B19V), a single-stranded DNA virus in the family Parvoviridae, is a human pathogenic virus, characterized by a selective but not exclusive tropism for erythroid progenitor cells. Widely diffuse, it is responsible for an ample range of clinical manifestations, whose characteristics and outcomes depend on the interplay between the viral properties and the physiological and immune status of the infected individuals. The complexity of virus-host relationship and the diversity of the clinical course of infection pose a diagnostic challenge that may require non-trivial solutions...
July 26, 2018: Expert Review of Molecular Diagnostics
Gerald J Kost
US hospitals that admitted Ebola virus disease (EVD) patients mitigated risk by using point-or-care testing (POCT) for critical support in isolation units. Success proved unequivocally the need for POCT. Additionally, molecular diagnostics have been used to help stop new outbreaks, and even handheld diagnostic solutions are emerging. Areas covered: This update of 'Molecular detection and point-of-care testing in Ebola virus disease and other threats' [Expert Reviews 2015;15(10):1249-1255], assesses the impact of EVD epidemics, documents insights from recent reviews, summarizes evolving POC molecular technologies, presents General Accountability Office (GAO) recommendations, identifies the role of POC Coordinators, and casts a vision for national POCT policies and guidelines...
July 20, 2018: Expert Review of Molecular Diagnostics
Rhiannon Mellis, Natalie Chandler, Lyn S Chitty
The advent of affordable and rapid next-generation sequencing has been transformative for prenatal diagnosis. Sequencing of cell-free DNA in maternal plasma has enabled the development of not only a highly sensitive screening test for fetal aneuploidies, but now definitive noninvasive prenatal diagnosis for monogenic disorders at an early gestation. Sequencing of fetal exomes offers broad diagnostic capability for pregnancies with unexpected fetal anomalies, improving the yield and accuracy of diagnoses and allowing better counseling for parents...
July 18, 2018: Expert Review of Molecular Diagnostics
Kenneth Pritzker
No abstract text is available yet for this article.
July 6, 2018: Expert Review of Molecular Diagnostics
Emily C Lydon, Emily R Ko, Ephraim L Tsalik
A century of advances in infectious disease diagnosis and treatment changed the face of medicine. However, challenges continue to develop including multi-drug resistance, globalization that increases pandemic risks, and high mortality from severe infections. These challenges can be mitigated through improved diagnostics, and over the past decade, there has been a particular focus on the host response. Since this article was originally published in 2015, there have been significant developments in the field of host response diagnostics, warranting this updated review...
July 2, 2018: Expert Review of Molecular Diagnostics
Alessia Cimadamore, Silvia Gasparrini, Matteo Santoni, Liang Cheng, Antonio Lopez-Beltran, Nicola Battelli, Francesco Massari, Francesca Giunchi, Michelangelo Fiorentino, Marina Scarpelli, Rodolfo Montironi
Over the last decade, the improvement in molecular techniques and the acquisition of genomic information has transformed and increased the quality of patient care and our knowledge of diseases. Areas covered: Protein expression levels in immunohistochemistry and molecular biomarkers are reported for their ability to predict recurrence, progression, development of metastases, or patient survival. In particular, for renal cell carcinoma, we take into consideration the biomarkers applicable to immunohistochemistry and with molecular and genetic analyses...
June 29, 2018: Expert Review of Molecular Diagnostics
Catherine A Hogan, Chelsea Caya, Jesse Papenburg
Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infections. The clinical manifestations of RSV are indistinguishable from other etiologies of acute respiratory infection. Therefore, accurate and timely laboratory testing is needed to impact clinical management. There are now multiple rapid, low-complexity, commercially available assays for RSV. These tests present significant performance advantages compared to older antigen detection tests. Accurate and rapid diagnosis of RSV has the potential for enabling timely cessation of unnecessary antibiotics and implementation of good infection control practices...
June 29, 2018: Expert Review of Molecular Diagnostics
Matthew W McCarthy, Thomas J Walsh
Clinical trials for invasive pulmonary aspergillosis, a potentially lethal mold infection, are complex investigations that require protracted time and extensive resources, delaying the development of new antifungal agents for this important disease. Areas covered: In this paper, the authors examine a novel approach to study invasive pulmonary aspergillosis in humans, with a focus on the potentials and pitfalls of surrogate end points such as galactomannan antigenemia to evaluate therapeutic response to novel compounds...
June 20, 2018: Expert Review of Molecular Diagnostics
John D Diaz-Decaro, Nicole M Green, Hilary A Godwin
Clinical management and identification of respiratory diseases has become more rapid and increasingly specific due to widespread use of PCR(polymerase chain reaction) multiplex technologies. Although significantly improving clinical diagnosis, multiplexed PCR assays could have a greater impact on local and global disease surveillance. The authors wish to propose methods of evaluating respiratory multiplex assays to maximize diagnostic yields specifically for surveillance efforts. Areas covered: The authors review multiplexed assays and critically assess what barriers have limited these assays for disease surveillance and how these barriers might be addressed...
June 19, 2018: Expert Review of Molecular Diagnostics
Elisa Bevilacqua, Serena Resta, Andrew Carlin, Xin Kang, Teresa Cos Sanchez, Jérôme de Marchin, Jacques C Jani
Roche's Ariosa HarmonyTM Prenatal Test, a noninvasive cfDNA (cell-free DNA) method for major trisomies has been available since January-2013 at the authors unit and tests were sent to California. From July-2017 onwards, prenatal cfDNA has been reimbursed in Belgium for all pregnancies, however since then samples are sent to a local technology transfer center. Little data are available on patient's profile and choices towards cfDNA and on the performance of local technology transfer centers. Areas covered: The profiles and choices of women regarding this test were evaluated...
June 18, 2018: Expert Review of Molecular Diagnostics
Alexander L Greninger
Diagnostic metagenomics and its associated trail of publications are spreading across the world. Multiple clinical labs in the United States, Europe, and Asia have gone to considerable lengths to optimize and validate a range of protocols for agnostically detecting viral, bacterial, fungal, and eukaryotic parasite nucleic acid across a range of patient specimens to aid in diagnosis for particularly recalcitrant cases. Others see a role for diagnostic metagenomics as a frontline diagnostic to replace other microbiological testing...
June 18, 2018: Expert Review of Molecular Diagnostics
Danai Mavreli, Nikolas Papantoniou, Aggeliki Kolialexi
No abstract text is available yet for this article.
June 5, 2018: Expert Review of Molecular Diagnostics
Sreelakshmi Kotha, ShuetFong Neong, Keyur Patel
Chronic liver disease due to viral hepatitis continues to be a major global health concern. Timely diagnosis and treatment will prevent cirrhosis, risk of hepatocellular carcinoma (HCC), and requirement for liver transplantation. Numerous serum biomarkers are available for viral hepatitis that are helpful in diagnosis, measuring severity, progression of disease, evaluating the best therapeutic options, and monitoring antiviral treatment response. Determining the clinical use of available diagnostic tests can be challenging for the health care provider...
August 2018: Expert Review of Molecular Diagnostics
David Millington, Scott Norton, Raj Singh, Rama Sista, Vijay Srinivasan, Vamsee Pamula
Digital microfluidics (DMF) is an emerging technology with the appropriate metrics for application to newborn and high-risk screening for inherited metabolic disease and other conditions that benefit from early treatment. Areas covered: This review traces the development of electrowetting-based DMF technology toward the fulfillment of its promise to provide an inexpensive platform to conduct enzymatic assays and targeted biomarker assays at the bedside. The high-throughput DMF platform, referred to as SEEKER®, was recently authorized by the United States Food and Drug Administration to screen newborns for four lysosomal storage disorders (LSDs) and is deployed in newborn screening programs in the United States...
August 2018: Expert Review of Molecular Diagnostics
Kevin J H Janssen, Jeanne A M C Dirks, Nicole H T M Dukers-Muijrers, Christian J P A Hoebe, Petra F G Wolffs
Chlamydia trachomatis (chlamydia) is the most commonly diagnosed bacterial sexually transmitted infection (STI) worldwide. The advancement of molecular techniques has made chlamydia diagnostics infinitely easier. However, molecular techniques lack the information on chlamydia viability. Where in routine diagnostics the detection of chlamydia DNA or RNA might suffice, in other patient scenarios, information on the viability of chlamydia might be essential. Areas covered: In this review, the authors discuss the specific strengths and limitations of currently available methods to evaluate chlamydia viability: conventional cell culture, messenger RNA (mRNA) detection and viability-PCR (V-PCR)...
August 2018: Expert Review of Molecular Diagnostics
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