Article
Medicine, General & Internal
Clara Wollenhaupt, Thomas Sudhop, Werner Knoess
Summary: The EU's IVDR introduces companion diagnostics (CDx) as a new legal term, aimed at identifying patient subgroups most likely to benefit from a treatment. A systematic search in a clinical trials database identified 3643 trials conducted between 2004 and 2022, analyzing the use of biomarker testing in patient stratification, with PD-L1 and HER2 being the most frequently tested biomarkers. The findings also suggest overlap with non-European authorities implementing the CDx concept, indicating potential CDx candidates under the IVDR.
Article
Microbiology
T. P. McCarty, P. Cumagun, J. Meeder, D. Moates, W. S. Edwards, J. Hutchinson, R. A. Lee, S. M. Leal Jr
Summary: The GenMark Dx ePlex system enables earlier identification of antimicrobial-resistant Gram-negative bacteria causing bloodstream infections, leading to discontinuation of unnecessary antibiotics. Its performance is superior to traditional methods, providing results much earlier. In addition, it detects bacteria harboring the CTX-M gene and enables optimization of ineffective therapy.
MICROBIOLOGY SPECTRUM
(2023)
Article
Chemistry, Multidisciplinary
Jiayingzi Wu, Yafei Zhang, Kejia Jiang, Xiaoyu Wang, Nicholas Thomas Blum, Jing Zhang, Shanshan Jiang, Jing Lin, Peng Huang
Summary: This study presents a glucose oxidase-engineered nanoplatform for activatable imaging-based companion diagnostics and multistage augmented photothermal/starvation synergistic therapy. The nanoplatform utilizes a pH-activatable conjugated polymer as a photothermal converter and photoacoustic emitter, glucose oxidase as a cancer starvation inducer, and a H2O2-cleavable linker as a switch for enzyme activity. The in vivo imaging and therapy abilities are activated by the acidic tumor microenvironment and self-augmented by the reaction between glucose oxidase and glucose.
ADVANCED MATERIALS
(2022)
Review
Oncology
Jan Trost Jorgensen, Henrik Winther, Jon Askaa, Lena Andresen, Dana Olsen, Jens Mollerup
Summary: The development of trastuzumab was a significant achievement in cancer drug development, pioneering the drug-diagnostic codevelopment model. Accurate and robust HER2 detection assays were crucial for selecting the right patient population likely to respond to the drug.
FRONTIERS IN ONCOLOGY
(2021)
Review
Pharmacology & Pharmacy
Ciska Verbaanderd, Ana Trullas Jimeno, Joerg Engelbergs, Hilke Zander, Ilona Reischl, Ana Moreno Oliver, Spiros Vamvakas, Camille Vleminckx, Christelle Bouygues, Thomas Girard, Francesca Day, Zaide Frias
Summary: The new In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) brings significant changes to the EU legal framework for companion diagnostics (CDx), including a risk-based classification system for in vitro diagnostic tests (IVDs) and enhanced involvement of notified bodies in the certification process. It also establishes a link between CDx assessment and medicinal products, requiring scientific opinions from medicines regulators. However, challenges like insufficient capacity of notified bodies and manufacturer readiness exist. The progressive roll-out and increased collaboration among stakeholders will ensure timely access to essential IVDs.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Infectious Diseases
Zoe Freeman Weiss, Alexander D. Pyden, Tulip A. Jhaveri, Sanjat Kanjilal
Summary: Microbial cell free DNA sequencing was used in a single-center retrospective case series to study its clinical reasoning and impact. The testing had positive impact in 45% of cases, especially for patients with high pre-test probability for infection. Further research is needed to optimize the timing of the testing.
DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
(2023)
Review
Veterinary Sciences
Binu T. Velayudhan, Hemant K. Naikare
Summary: The advancement of laboratory diagnosis of animal diseases has led to an increasing demand for point-of-care testing in animal health and disease diagnostics. A variety of assays based on antibodies, antigens, nucleic acid, and nanopore sequencing are currently available, each with its own advantages and disadvantages. Ongoing research and development activities are focused on improving existing tests and developing newer, better tests.
FRONTIERS IN VETERINARY SCIENCE
(2022)
Article
Clinical Neurology
Eric Wesner, Lacey Etzkorn, Shivani Bakre, Jinyu Chen, Alexander Davis, Yifan Zhang, Sevil Yasar, Aruna Rao, Mark Luciano, Jiangxia Wang, Abhay Moghekar
Summary: This study aimed to estimate reliable change thresholds for the Montreal Cognitive Assessment (MoCA) in older adults with suspected Idiopathic Normal Pressure Hydrocephalus (iNPH) and identify predictors of improvement. The results showed that a 5-point increase in MoCA was reliable for patients with a baseline MoCA from 16 to 22. 23.4% of shunted patients improved by at least 5 points on the MoCA after shunt insertion. Time since onset of memory problems and post-tap test/extended lumbar drainage gait function were significantly associated with reliable change in MoCA.
FRONTIERS IN NEUROLOGY
(2022)
Article
Microbiology
Caitlin Naureckas Li, Mari M. Nakamura
Summary: Broad-range PCR sequencing is a promising tool for diagnosing infectious conditions when traditional microbiologic strategies fail. However, our study found that its impact on clinical management varies depending on the sample type.
JOURNAL OF CLINICAL MICROBIOLOGY
(2022)
Article
Sport Sciences
Nicholas K. Erdman, Patricia M. Kelshaw, Samantha L. Hacherl, Shane Caswell
Summary: The study aimed to evaluate the role of Child SCAT5 in assessing middle school children with suspected concussion. The results showed that on the day of suspected concussion, concussed children had more and more severe symptoms, and higher mBESS scores. There were no significant differences in SAC-C scores. The quantity and severity of symptoms were the most effective factors in differentiating concussed and non-concussed children.
SPORTS MEDICINE-OPEN
(2022)
Article
Oncology
Daniel L. L. Hertz
Summary: This article calls for clinicians and clinical guidelines committees in the United States to re-evaluate the clinical utility of pretreatment DPYD testing. There is no direct evidence of efficacy reduction, and the available indirect evidence suggests that DPYD-guided FP dosing is well calibrated and minimizes the risk of reducing treatment efficacy.
JOURNAL OF CLINICAL ONCOLOGY
(2022)
Review
Medicine, General & Internal
Sriram Kalpana, Wan-Ying Lin, Yu-Chiang Wang, Yiwen Fu, Hsin-Yao Wang
Summary: New antimicrobial approaches are necessary due to antimicrobial resistance. Existing drug development has been hindered by resistance, leading to unsuccessful trials. Unconventional antimicrobial molecules, such as monoclonal antibodies, peptides, aptamers, and phages, are being considered as potential alternatives. Diagnostic-based treatments for infectious diseases using alternate therapeutics, considering the detection, monitoring of response, and resistance mechanism identification, disrupt traditional therapeutic development. This review highlights the correlation between alternate antimicrobial therapeutics and infectious diseases, analyzing pharmacodynamic parameters and the potential use of companion diagnostic applications.
Article
Psychology, Multidisciplinary
Edoardo Nicolo Aiello, Federica Solca, Silvia Torre, Laura Carelli, Roberta Ferrucci, Alberto Priori, Federico Verde, Vincenzo Silani, Nicola Ticozzi, Barbara Poletti
Summary: This study found that MoCA has good diagnostic properties as a screener for cognitive impairment in non-demented ALS patients, especially for ruling out the occurrence of cognitive impairment, as long as patients are in the early stages of the disease and have sufficiently spared bulbar and upper-limb functions.
FRONTIERS IN PSYCHOLOGY
(2022)
Review
Chemistry, Analytical
Le Minh Tu Phan, My-Van Tieu, Thi-Thu Pham, Sungbo Cho
Summary: Despite global efforts, the COVID-19 pandemic continues to spread, posing challenges to public healthcare systems. Before widespread vaccine availability, improving biosensor efficacy is crucial for accurate diagnosis of SARS-CoV-2 infection. Scientists are making intensive efforts to enhance current biosensors and develop integrated diagnostic tools for effective clinical diagnosis and future pandemic preparedness.
Article
Immunology
Alexander Franklin, Teny M. John, Fareed Khawaja, Ying Jiang, Eduardo Yepez, Jitesh Ahuja, Saadia A. Faiz, Lara Bashoura, Ajay Sheshadri, Vickie R. Shannon, Diwakar D. Balachandran, Kelly McConn, Victor E. Mulanovich, Micah Bhatti, Roy F. Chemaly
Summary: There is a discrepancy between nasopharyngeal swab and bronchoalveolar lavage polymerase chain reaction for SARS-CoV-2 in patients with cancer. Bronchoalveolar lavage has value in certain patients with a high clinical suspicion of COVID-19.
JOURNAL OF INFECTIOUS DISEASES
(2023)
