Search Results for “diagnostic” – Page 3 – media

World’s First Low-Cost, High-Throughput, Near-Patient Molecular Diagnostic Test System Dramatically Reduces Wait Times

It is important for doctors to rapidly and accurately identify prevalent respiratory pathogens like COVID-19, influenza A and B, RSV-A, and RSV-B for administering prompt, tailored treatment to infected individuals. In a significant advancement, a near-patient test system using automation technology detects pathogens with unrivaled speed and cuts the typical waiting time of 24 to 48 hours to just one to two hours without the need for expensive biosafe laboratories. Fast MDx Limited (Middlesex, UK) and Festo (London, UK) have jointly designed and developed the world’s first, low-cost, high-throughput, near-patient molecular diagnostic test system that will provide clinicians with earlier, more informed results, allowing each patient to receive a faster, personalized clinical pathway. The Fast MDx system comprises everything necessary for testing, including sample tubes, swabs, and even electronic result transmission to the originating hospital, clinic, or doctor’s office. The system incorporates Fast MDx’s latest, ultra-fast, NGx2 4-Channel qPCR thermal ...
- Source: drugdu
- 111
- February 29, 2024
Portable Rapid PCR Diagnostic to Detect Gonorrhea and Antibiotic Susceptibility

Gonorrhea, ranked as the second most reported bacterial sexually transmitted infection (STI), affected approximately 82 million people globally in 2020. The infection can lead to severe health complications, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Untreated gonorrhea may progress to the bloodstream, posing a life-threatening risk and increasing the likelihood of HIV infection. Many cases go unreported due to asymptomatic patients, implying that the actual burden of the disease may be significantly higher. Now, a rapid test aims to identify gonorrhea and also determine its antibiotic susceptibility. Visby Medical (San Jose, CA, USA) has been awarded up to USD 1.8 million by CARB-X (Boston, MA, USA) for the development of a portable rapid polymerase chain reaction (PCR) diagnostic to identify the presence of Neisseria gonorrhoeae (NG), the pathogen responsible for gonorrhea, and ascertain its susceptibility to ciprofloxacin. Ciprofloxacin was once a primary oral antibiotic for treating NG but ...
- Source: drugdu
- 151
- February 16, 2024
Electrochemical Sensors with Next-Generation Coating Advances Precision Diagnostics at POC

Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
- Source: https://www.labmedica.com/clinical-chemistry/articles/294800220/electrochemical-sensors-with-next-generation-coating-advances-precision-diagnostics-at-poc.html
- 124
- February 14, 2024
Novel Urinary Biomarkers with Improved Diagnostic Performance to Enable Early Detection of Lupus Nephritis

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 ...
- Source: drugdu
- 90
- January 25, 2024
【EXPERT Q&A】Which in vitro diagnostic medical devices are required to be assessed by EURLs for export to the EU, and what are the specific reference laboratories involved?

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 ...
- Source: drugdu
- 133
- January 25, 2024
Ultrasensitive Molecular Diagnostic Tools Detect Asymptomatic Malaria

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 ...
- Source: drugdu
- 168
- January 22, 2024
Novel Diagnostic Combines Inhalable Sensors with Urine Test for Early Lung Cancer Detection

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 ...
- Source: drugdu
- 93
- January 10, 2024
AMP Publishes Best Practice Guidance for Slice Testing Approach in Diagnostics

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 ...
- Source: drugdu
- 137
- December 29, 2023
Fosun Diagnostics’ Fully Automated Chemiluminescence Immunoassay Analyzer F-i1000 Obtains EU IVDR Certification

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 ...
- Source: drugdu
- 105
- December 29, 2023
New Sample Preparation Solutions Simplify and Automate Respiratory Diagnostic Testing

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 ...
- Source: drugdu
- 111
- December 15, 2023

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