Systemic Lupus Erythematosus (SLE), widely known as lupus, is an autoimmune condition where the body’s immune system mistakenly attacks its own tissues and organs. This disease can lead to inflammation affecting various body parts, including joints, skin, kidneys, blood cells, brain, and heart. Among its manifestations, lupus nephritis stands out as one of the most severe and common, often resulting in significant morbidity and mortality. Early detection of kidney involvement in lupus patients and prompt intervention are critical in mitigating the associated pain, suffering, and potential fatality. Now, researchers have discovered new biomarkers with improved diagnostic performance for the early detection of lupus nephritis. In a significant advancement, a research team from the University of Houston (Houston, TX, USA) employed Proximity Extension Assay (PEA) proteomics—a method focused on the study of proteins in terms of their interactions, functions, compositions, and structures—on urine samples from lupus patients. This approach led to ...
Drugdu.com expert’s response: For the export of in vitro diagnostic (IVD) medical devices to the European Union, certain types of products may require assessment or testing by designated European Union Reference Laboratories (EURLs). These reference laboratories mainly focus on high-risk in vitro diagnostic medical devices, particularly those closely related to public health. The types of IVD products typically evaluated by EURLs include: Infectious Disease Diagnostic Devices: For detecting major infectious diseases such as HIV, Hepatitis B, and Hepatitis C. Blood Screening Devices: Used for blood safety testing, such as devices for detecting pathogens in blood. High-Risk Cancer Biomarker Diagnostic Devices: For detecting high-risk biomarkers of certain types of cancer. Genetic Disease Diagnostic Devices: For detecting specific genetic diseases or susceptibilities. The EU designated reference laboratories include: ECDC (European Centre for Disease Prevention and Control): Responsible for the detection and control of infectious diseases. EURL for Blood Borne Infections: Specifically responsible ...
Malaria remains a significant cause of illness and death, particularly in low-income countries, striking hardest among young children and pregnant women. In 2022 alone, the World Health Organization reported 608,000 malaria deaths globally, with a staggering 95% of these occurring in the African region. A key challenge in controlling malaria, especially in endemic areas, is identifying and treating asymptomatic carriers of the disease. In response to this challenge, researchers have developed advanced diagnostic tools capable of detecting even minimal traces of malaria in individuals who carry the parasite but do not exhibit symptoms. A collaborative effort between scientists from the University of Washington (Seattle, WA, USA) and Med Biotech Laboratories (Kampala, Uganda) has led to significant advancements in malaria detection. The researchers observed that malaria parasite densities in the blood can suddenly fall below the detection threshold of traditional tests due to the evolving nature of the malaria pathogens. This ...
Cancer, particularly lung cancer driven by pollution and smoking, is expected to increasingly afflict populations in low- and middle-income countries. To catch lung cancer at its earliest and most treatable stages, it’s recommended that heavy smokers over 50 years get annual CT scans. Yet, many in this demographic do not undergo these scans, and the high rate of false positives from the scans can lead to unwarranted and invasive follow-up tests. Now, a breakthrough diagnostic method that combines inhaling nanoparticle sensors with a simple urine test can detect the presence of a tumor. This innovative approach, which could potentially replace or complement low-dose computed tomography (CT) scans, could be especially promising for regions with limited access to CT technology. Developed by the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA), this new technology is the culmination of a decade’s work on nanosensors aimed at cancer and other diseases diagnosis. These ...
As the discovery of genes linked to a variety of inherited conditions accelerates, clinical labs are finding it increasingly challenging to keep up with multiple assays dedicated to specific disease-related gene panels. To streamline this process, labs are adopting a ‘slice testing’ approach that employs a comprehensive capture backbone to analyze data pertinent to a specific gene set. Like conventional disease-focused panels, slice testing sequences a wide array of genes but narrows down the analysis to a pre-selected group of pertinent genes. This method combines the benefits of high-quality gene panels with the wider scope and adaptability of exome sequencing. The Association for Molecular Pathology (AMP, Rockville, MD, USA) has released a detailed report that explores the unique aspects of employing a slice testing strategy for diagnostic purposes. This includes the intricacies of gene selection, analytical performance, coverage, quality, and data interpretation. The report consolidates expert consensus recommendations and findings ...
Recently, Fosun Diagnostics announced that its fully automated chemiluminescence immunoassay analyzer, F-i1000, has received approval for EU IVDR CE registration. The issuance of the registration certificate under the IVDR regulation signifies international recognition of the quality of Fosun Diagnostics’ chemiluminescence products and the ability to meet diverse testing requirements for projects in various levels of medical institutions such as hospitals, core laboratories, and clinics, both domestically and internationally. CE certification is granted based on relevant EU laws, regulations, and standards, serving as a passport for products to freely circulate in the EU market. On May 5, 2017, the EU released the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746), replacing the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, Directive 98/79/EC). After the transition period following the regulation’s implementation, in vitro diagnostic medical devices without IVDR CE certification will no longer be allowed to enter the EU ...
Clinical laboratories performing respiratory testing are required to generate results of the highest quality results. Now, an automated nucleic acid purification instrument along with kits for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens has been designed to fulfill the requirements of these laboratories. Thermo Fisher Scientific Inc. (Waltham, MA; USA) has launched the high-throughput, versatile KingFisher Apex Dx system that allows scientists’ labs to recover quality nucleic acids for sensitive downstream applications with maximum consistency, reproducibility, and reliability. The system has been designed to be a part of modular sample preparation for real-time PCR analysis workflow, providing precise results, accurate data management, and robust security features that meet cybersecurity and diagnostic regulatory standards. Additionally, Thermo Fisher has launched the MagMAX Dx Viral/Pathogen NA Isolation kit which offers advanced formulation to ensure reproducible results and is automation-compatible with the KingFisher Apex Dx. These products together ...
Neurodegenerative disorders are often marked by the buildup of amyloid filament inclusions of specific proteins in the brain. These proteins are critical in diagnosing and treating the associated diseases. Frontotemporal lobar degeneration (FTLD) is one such disorder, leading to frontotemporal dementia, which ranks just behind Alzheimer’s disease in prevalence. In about 10% of FTLD cases, the identity of the filament-forming protein was previously unknown. The protein FUS was the suspected culprit, given its presence in brain inclusions and its known genetic role in some instances of amyotrophic lateral sclerosis, another neurodegenerative condition. Now, researchers using electron cryo-microscopy have unexpectedly found that the filaments are instead formed by the protein TAF15. The research team from MRC Laboratory of Molecular Biology (Cambridge, UK) extracted amyloid filaments from the brains of four individuals affected by this type of FTLD. They carried out neuropathological examinations on the brain tissues obtained. Employing electron cryo-microscopy, they ...
Bright Uro raised $23 million in Series A funds to help achieve FDA clearance for its urodynamics system and launch the product in the U.S. Should it be cleared, the system will become the first product on the market able perform urodynamic monitoring wirelessly and without a catheter, the company’s CEO said. By KATIE ADAMS Bright Uro, a Irvine, California-based startup founded in 2021, is on a mission to make urodynamic testing more accurate for clinicians, more comfortable for patients, and more efficient for clinics. On Thursday, the company announced it has raised $23 million to help it get closer to achieving those goals — the Series A funding round was led by Laborie Medical Technologies, a provider of urology diagnostic and therapeutic products. The round reflects the total amount of equity investment Bright Uro has raised since its founding, said CEO Derek Herrera. The startup also received a $2 ...
Centogene has published data about the use of lyso-Gb1 (glucosylsphingosine) as a sensitive diagnostic and predictive biomarker for Gaucher disease. The study was published in the open-access MDPI journal, Diagnostics, and showed that lyso-Gb1 could be used to predict the clinical course of patients with Gaucher disease. Gaucher disease is a rare inherited metabolic disorder caused by mutations in the beta-glucocerebrosidase (GBA1) gene, responsible for producing a fat-breaking enzyme, glucocerebrosidase. Decreased activity of the enzyme causes fat accumulation in the cells causing symptoms such as liver enlargement, anaemia, bone pain, and spleen enlargement. Multiple biomarkers have been identified for the disease. However, these were present in other diseases and not exclusively in Gaucher disease. Lyso-Gb1 is a more specific biomarker for Gaucher’s, and it can be used to both diagnose the disease and monitor its progression. The confirmation of the biomarker serves as an important step forward in rare disease ...
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