Search Results for “diagnostic” – media

【EXPERT Q&A】What are the requirements for naming in vitro diagnostic reagents?

Drugdu.com expert’s response: The naming of in vitro diagnostic reagents must follow a series of clear requirements to ensure the standardization, accuracy, and ease of understanding of the names. These requirements mainly include the following points: Ⅰ. Naming Structure The product name of in vitro diagnostic reagents typically consists of three parts: Name of the Substance Being Tested: This is the target substance that the reagent detects, and the name should accurately reflect the characteristics of the substance being tested. Purpose: Describes the purpose of the reagent, such as “assay kit,” “quality control material,” etc. This part helps users understand the specific application of the reagent. Method or Principle: Explains the method or principle of the reagent’s detection, such as “magnetic bead-based chemiluminescent immunoassay,” “fluorescent PCR method,” “fluorescent in situ hybridization,” etc. This information is usually listed in parentheses to provide additional technical details. Ⅱ. Specific Naming Rules Quantitative vs. Qualitative ...
- Source: drugdu
- 38
- November 18, 2024
PCR new legend debuts at CIIE! Roche Diagnostics releases LightCycler® PRO

Today, at the 7th China International Import Expo (hereinafter referred to as “CIIE”), Roche Diagnostics China announced that its new molecular detection platform LightCycler® PRO System real-time fluorescence quantitative PCR instrument* (hereinafter referred to as “LightCycler® PRO”) was officially launched in China. Wang Feng, Senior Director of Roche Diagnostics China – Life Sciences Department, Marcus Droege, CEO of TIB Molbiol, James Lee, Global Senior Product Manager of Roche Diagnostics, and other guests attended the LightCycler® PRO launch conference. “As a global leader in in vitro diagnostics, Roche Diagnostics has always empowered scientific research with cutting-edge innovative technologies and led the development of the industry. LightCycler® PRO is another breakthrough innovation in the field of molecular testing. It can achieve 7-channel multiplex testing and has powerful advantages such as accuracy, high efficiency, flexibility, and ease of use. We hope that this time, with the help of the CIIE, it will officially ...
- Source: drugdu
- 53
- November 8, 2024
Siemens Healthineers plans to acquire Novartis’ diagnostic business for €200 million

Recently, according to the Financial Times, Siemens Healthineers plans to acquire the diagnostic business of Advanced Accelerator Applications (AAA), a subsidiary of Novartis, for 200 million euros (approximately 1.593 billion yuan). AAA specializes in producing radioactive nuclide drugs, also known as nuclear drugs, for molecular imaging equipment PET (positron emission tomography). The transaction is expected to be completed in the fourth quarter. Expand business territory AAA was spun off from the European Organization for Nuclear Research (CERN) in 2002 and is an innovative radiopharmaceutical company focused on targeted radioligand therapy, precise radioligand imaging, and molecular imaging product development. Its main focus is on the development, production, and commercial application of Molecular Nuclear Medicine (MNM) products. On October 30, 2017, Novartis acquired the company for $3.9 billion to strengthen its radiopharmaceutical business capabilities, making AAA a subsidiary of Novartis. After years of development, AAA has built a pipeline covering various diagnostic ...
- Source: drugdu
- 93
- August 30, 2024
Roche Joins Fight Against Mpox Outbreak with High-Quality PCR Diagnostic Tests

Mpox, formerly known as monkeypox, is a viral disease that can spread easily between people and from infected animals. The mpox virus was first detected in laboratory monkeys in 1958. The virus is, however, assumed to be transmitted from wild animals such as rodents to people — or from human to human. Symptoms of mpox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes, and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab, and fall off. Mpox was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) on August 14, 2024. Roche (Basel, Switzerland) has announced that it is supporting the international response to the mpox global health emergency with ...
- Source: drugdu
- 64
- August 27, 2024
Genetic Analysis of Lyme Disease Bacteria to Enable More Accurate Diagnostic Tests

Lyme disease is the most prevalent tick-borne illness in North America and Europe, affecting hundreds of thousands of individuals annually. The disease is caused by bacteria from the Borrelia burgdorferi sensu lato group, which are transmitted to humans through the bites of infected ticks. Symptoms typically include fever, headache, fatigue, and a distinctive skin rash. If not treated promptly, the infection can spread to the joints, heart, and nervous system, leading to more severe complications. Now, researchers have conducted a genetic analysis of the bacteria responsible for Lyme disease, potentially leading to advancements in the diagnosis, treatment, and prevention of this tick-borne illness. A research team led by biologists at CUNY Graduate Center (New York, NY, USA) has mapped the complete genetic sequences of 47 strains of Lyme disease-related bacteria from across the globe, creating a valuable resource for identifying the specific bacterial strains that infect patients. This genetic data ...
- Source: drugdu
- 73
- August 23, 2024
Rapid Diagnostic System to Deliver Same-Shift Antibiotic Susceptibility Test Results

The World Health Organization estimates that sepsis impacts around 49 million people worldwide each year, resulting in roughly 11 million deaths, with about 1.32 million of these deaths directly linked to bacterial antimicrobial resistance. Given the urgency, there’s a growing need for rapid antimicrobial susceptibility testing (AST) that can guide the use of targeted antimicrobial therapies. Such testing is crucial for enhancing patient outcomes, reducing hospital costs, and curbing the rise of antimicrobial resistance. Now, a rapid AST system aims to deliver same-shift results, significantly aiding antimicrobial stewardship teams and clinicians in promptly customizing treatments for patients with severe infections. The WAVE system from Accelerate Diagnostics (Tucson, AZ, US) is designed to deliver rapid AST results from positive blood culture (PBC) bottles and isolated bacterial colonies (isolates), delivering precise results in approximately 4.5 hours. Utilizing cutting-edge holographic imaging technology, the WAVE system tracks bacterial growth and morphology changes in real-time, ...
- Source: drugdu
- 83
- August 22, 2024
FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

NOWDiagnostics’ First to Know has FDA De Novo marketing authorization as a new test for syphilis. The at-home product needs only a single drop of blood to test for this sexually transmitted infection. By Frank VinluanSyphilis testing typically requires obtaining a blood sample and sending it to a lab. The wait for results ranges from hours to days. The FDA has authorized a new at-home syphilis test, a NOWDiagnostics product that yields results within 15 minutes. The FDA said Friday that its marketing authorization for the NOWDiagnostics test makes the kit the first at-home, over-the-counter test for syphilis. Springdale, Arkansas-based NOWDiagnostics, or NOWDx, will market its new syphilis test as First-to-Know. Syphilis is caused by a bacterium, Treponema pallidum. It’s treatable with antibiotics, such as penicillin. Untreated, syphilis infection can damage the heart and the brain. This infection can also cause blindness, deafness, and paralysis. Reports of this sexually transmitted ...
- Source: drugdu
- 96
- August 20, 2024
New Visual Diagnostic Technique to Advance Early Detection of Neurodegenerative Diseases

Parkinson’s disease is identified by the buildup of misfolded alpha-synuclein proteins, which are crucial to the function of neural cells in the brain. This condition impacts millions globally, creating substantial hurdles in both early detection and treatment. Typically, Parkinson’s is diagnosed in later stages through clinical observation of physical symptoms, which often delays the application of potential treatments. Early diagnosis currently depends on sophisticated, costly equipment that is not widely accessible, particularly in less developed regions. Researchers have now introduced a novel visual diagnostic approach aimed at improving early detection capabilities for neurodegenerative diseases like Parkinson’s. Named Cap-QuIC (Capillary-enhanced Quaking-Induced Conversion), the techniques developed by researchers at the University of Minnesota (Minneapolis, MN, USA), allows clinicians to visually identify infected samples, enhancing both the affordability and accessibility of testing. Building on their earlier diagnostic advancements, Cap-QuIC employs a simple technique to visually detect misfolded alpha-synuclein proteins. In their research published ...
- Source: drugdu
- 69
- August 9, 2024
Handheld Device Puts Power of Lab-Based Diagnostic Testing in the Palm of Your Hand

Many common tests for infectious diseases work by detecting either antigens related to the virus or antibodies created in response to the infection. These tests, which now include widely used COVID-19 rapid antigen tests, offer the advantages of speed and broad availability. However, polymerase chain reaction (PCR) tests still surpass these in terms of accuracy, reaching nearly 100%. PCR tests, considered the gold standard in infectious disease diagnostics, excel because they detect a pathogen’s genetic material like RNA directly. This capability increases specificity, reducing the likelihood of false positives. PCR can also amplify minimal amounts of genetic material, allowing it to detect infections at very low levels. Yet, PCR requires specialized skills and expensive equipment, which limits its availability, particularly in low-resource settings. Researchers at the University of Connecticut (Storrs, CT, USA) have now developed a platform technology that incorporates PCR-like capabilities within a handheld device, as detailed in ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801920/handheld-device-puts-power-of-lab-based-diagnostic-testing-in-the-palm-of-your-hand.html
- 118
- July 26, 2024
World’s First Rapid Diagnostic Test Detects Stroke within Minutes at POC

Each year, more than 20 million people worldwide suffer from strokes. Large vessel occlusions (LVO) constitute 30% of these cases but are behind 95% of the resulting disabilities and fatalities. The likelihood of recovery improves significantly if a procedure known as ‘thrombectomy’ is performed immediately after the onset of symptoms. However, speeding up this treatment is complicated because it’s difficult to identify LVO strokes outside hospital settings; symptoms can mimic other medical issues. Strokes can also result from blockages in smaller vessels or vessel ruptures, neither of which are suitable for thrombectomy. Ideally, LVO strokes need to be diagnosed quickly and before the patient arrives at the hospital to speed up the initiation of thrombectomy. Currently, there is no sufficiently accurate diagnostic tool for this purpose. Now, a groundbreaking diagnostic test can identify an LVO stroke within 15 minutes, expediting patient transfer to specialized care and saving more than 1 ...
- Source: drugdu
- 128
- July 23, 2024

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