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Expert Review of Molecular Diagnostics

Stephen Young, Barbara Body, Franklin Moore, Sherry Dunbar
The ARIES® HSV 1&2 Assay is a new FDA cleared real-time PCR test for detection and differentiation of HSV-1 and HSV-2 DNA from cutaneous and mucocutaneous lesions. The test is performed on the ARIES® System, an automated sample to answer real-time PCR instrument that provides a closed system and simple workflow for performing molecular testing. Areas Covered: This article reports the clinical performance of the ARIES® HSV 1&2 Assay assessed on 1963 prospectively collected specimens. Assay sensitivities were 91...
October 24, 2016: Expert Review of Molecular Diagnostics
André Huss, Mathias Buttmann, Isabel Brecht, Andreas Weishaupt, Markus Otto, Hayrettin Tumani
OBJECTIVES: Beside the determination of oligoclonal bands (OCBs) as a diagnostic biomarker in multiple sclerosis (MS), the presence of an intrathecal production of antibodies against the neurotropic viruses measles (M), rubella (R) and Varicella-Zoster (Z), the so called MRZ reaction (MRZR) is an even more specific diagnostic biomarker in MS. METHODS: We compared and validated the determination of the MRZR in 97 cerebrospinal fluid (CSF) and serum sample pairs of a bead-based multiplexing technique and a classical enzyme-linked immunosorbent assay (ELISA)...
October 19, 2016: Expert Review of Molecular Diagnostics
Christophe Roos
No abstract text is available yet for this article.
October 14, 2016: Expert Review of Molecular Diagnostics
Martin Barrio, Wolfgang P Fendler, Johannes Czernin, Ken Herrmann
Prostate specific membrane antigen (PSMA) has become an attractive diagnostic and therapeutic target for small molecule ligands. Radionuclide-chelating ligands can be labeled with either (68)Ga for positron-emission-tomography (PET) or (177)Lu for radionuclide therapy. Areas covered: In this literature review we evaluate the diagnostic value of (68)Ga PSMA PET/CT and the therapeutic potential of (177)Lu PSMA radioligand therapy (RLT) in patients with prostate cancer. (68)Ga PSMA PET/CT is more accurate than CT for nodal staging and superior to conventional imaging in patients with biochemical recurrence, translating into major changes in clinical management...
October 14, 2016: Expert Review of Molecular Diagnostics
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
Antonio L Teixeira, Haitham Salem, Benicio N Frey, Izabela G Barbosa, Rodrigo Machado-Vieira
Bipolar disorder is a chronic and disabling mood disorder with a complex pathophysiological basis. A significant percentage of patients do not receive correct diagnosis which directly influences therapeutic response, rendering recovery troublesome. There is a long-standing need for proper non-clinically based tools for diagnosis, treatment selection and follow-up of such patients. Areas covered: In the past decade, the scientific community has shown a great interest in biomarker development. Here, we highlight the different potential biomarkers and we discuss their feasibility and their possible clinical relevance...
October 13, 2016: Expert Review of Molecular Diagnostics
Nikolaos Tziolos, Evangelos J Giamarellos-Bourboulis
Introduction Although the administration of appropriate antimicrobials within the very first hour remains the mainstay of sepsis management, the correct selection of antimicrobials is hampered by the delay of conventional microbiology providing results after at least 48 hours. Methods of rapid detection of pathogens are an approach to overcome these difficulties. Areas covered This review analyzes the advantages and the disadvantages of these approaches with major emphasis on technologies based on multiplex PCR for the rapid detection of pathogens using whole blood...
October 11, 2016: Expert Review of Molecular Diagnostics
Barbara Van Der Pol
HSV-1 and HSV-2 are among the most common causes of sexually transmitted infections (stis) globally. these infections are strongly associated with increased risk of hiv acquisition and rare, but devastating, neonatal disease. available treatment options can reduce HSV transmission and improve quality of life. accurate diagnosis early in disease can improve patient management. Areas covered: This paper describes the clinical manifestations of HSV infection often used for clinical diagnostic purposes. The paper then describes the evolution of laboratory diagnostic assays...
October 8, 2016: Expert Review of Molecular Diagnostics
Tania B Lombo, Aniruddha Ganguly, Danilo A Tagle
No abstract text is available yet for this article.
October 8, 2016: Expert Review of Molecular Diagnostics
Mulias Lian, Hai-Yang Law, Caroline G Lee, Samuel S Chong
BACKGROUND: DMPK CTG-repeat expansions that cause myotonic dystrophy type 1 (DM1) can be detected more rapidly, cost-effectively, and simply by combining triplet-primed PCR (TP-PCR) with melting curve analysis (MCA). We undertook a detailed technical validation study to define the optimal operational parameters for performing bidirectional TP-PCR MCA assays. METHODS: We determined the assays' analytic specificity and sensitivity, assessed the effect of reaction volumes, DNA diluents, and common contaminants on melt peak temperature, determined the assays' sensitivity in detecting low-level mosaicism for repeat expansion, and evaluated their performance on two real-time PCR platforms...
October 8, 2016: Expert Review of Molecular Diagnostics
John W Belmont, Chad A Shaw
No abstract text is available yet for this article.
October 7, 2016: Expert Review of Molecular Diagnostics
Laura-Maria Krabbe, Solomon L Woldu, Shahrokh F Shariat, Yair Lotan
The high recurrence rates associated with non-muscle invasive bladder cancer requires close surveillance with cystoscopy, an invasive and expensive procedure with risk of missing cancer. Finding an accurate urinary biomarker that can detect recurrent disease would represent a significant advancement in management. Areas covered: This review summarizes the commercially-available urinary biomarkers including cytology, UroVysion, BTA, NMP22, uCyt+, and CxBladder assays. Additionally, we review recent investigational urinary biomarkers that hold promise in bladder cancer surveillance...
October 4, 2016: Expert Review of Molecular Diagnostics
Teresa Cimmino, Stéphanie Le Page, Didier Raoult, Jean-Marc Rolain
The dissemination of multi-drug resistant bacteria (MDRB) has become a major public health concern worldwide because of the increase in infections caused by MDRB, the difficulty in treating them, and expenditures in patient care. Areas covered: We have reviewed challenges and contemporary opportunities for rapidly confronting infections caused by MDRB in the 21st century, including surveillance, detection, identification of resistance mechanisms, and action steps. Expert commentary: In this context, the first critical point for clinical microbiologists is to be able to rapidly detect an abnormal event, an outbreak and/or the spread of a MDRB with surveillance tools so that healthcare policies and therapies adapted to a new stochastic event that will certainly occur again in the future can be implemented...
October 2, 2016: Expert Review of Molecular Diagnostics
(no author information available yet)
No abstract text is available yet for this article.
October 2016: Expert Review of Molecular Diagnostics
Michael Nasr, Tara Sigdel, Minnie Sarwal
Identification of allograft injury, including acute clinical and subclinical injury, is vital in increasing the longevity of the transplanted organ. Acute rejection, which occurs as a result of a variety of immune and non-immune factors including the infiltration of immune cells and antibodies to the donor specific epitopes, poses a significant risk to the organ. Recent years have marked an increase in the discovery of new genomic, transcriptomic, and proteomic biomarkers in molecular diagnostics, which offer better potential for personalized management of the transplanted organ by providing earlier detection of rejection episodes...
October 2016: Expert Review of Molecular Diagnostics
Carlo Buonerba, Giuseppe Di Lorenzo, Guru Sonpavde
Currently, clinical factors related to the malignancy and patient-related factors such as performance status and comorbidities are employed to select agents to treat metastatic castration resistant prostate cancer (mCRPC). Areas covered: This paper covers emerging molecular panels that may be used in the clinic as prognostic or predictive biomarkers to treat mCRPC. Expert commentary: The expression of androgen receptor variant (AR-V)-7 in circulating tumor cells appears especially promising to select patients for taxane chemotherapy versus androgen inhibitors, abiraterone and enzalutamide...
October 2016: Expert Review of Molecular Diagnostics
Jörg Ellinger, Heidrun Gevensleben, Stefan C Müller, Dimo Dietrich
Bodily fluids like serum and plasma contain significant amounts of tumor-derived circulating cell-free RNA, which holds the potential to serve as diagnostic biomarker. Consequently, liquid biopsies comprising circulating cell-free RNA might help to facilitate personalized treatment strategies for patients with renal cell carcinoma (RCC). Areas covered: The present review provides a summary of the literature obtained by a PubMed search and covers the current knowledge on circulating non-coding cell-free RNA in patients with RCC...
October 2016: Expert Review of Molecular Diagnostics
Shamzah Araf, Koorosh Korfi, Tahrima Rahim, Andrew Davies, Jude Fitzgibbon
The adoption of high-throughput technologies has led to a transformation in our ability to classify diffuse large B-cell lymphoma (DLBCL) into unique molecular subtypes. In parallel, the expansion of agents targeting key genetic and gene expression signatures has led to an unprecedented opportunity to personalize cancer therapies, paving the way for precision medicine. Areas covered: This review summarizes the key molecular subtypes of DLBCL and outlines the novel technology platforms in development to discriminate clinically relevant subtypes...
October 2016: Expert Review of Molecular Diagnostics
Jizhao Wang, Yuchen Sun, Jingkun Qu, Yan Yan, Ya Yang, Hui Cai
LPA and its receptors play an important role in mediating malignant behaviors in various cancers, including breast cancer. Aberrant expression of certain LPA receptors in breast cancer suggested that LPA receptors could be potential biomarkers in understanding malignant growth patterns of breast cancer. Further research considering molecular mechanisms for LPA receptors will contribute to new methods of malignant breast cancer diagnosis and treatment. Areas covered: Accumulating studies have indicated that LPA receptors correlated to proliferation, invasion, migration and metastasis both in vivo and in vitro...
October 2016: Expert Review of Molecular Diagnostics
Chiara Bacchelli, Hywel J Williams
Rare pediatric diseases are clinically severe with high rates of mortality and morbidity. This paper outlines how next-generation sequencing (NGS) can be used to greatly advance identification of the underlying genetic causes. Areas covered: This manuscript is a blend of evidence obtained from literature searches from PubMed and rare disease related websites, laboratory experience and the author's opinions. The paper covers the current state of the field and identifies where the challenges lie and how they are being overcome, using up-to-date references...
October 2016: Expert Review of Molecular Diagnostics
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