Antiphospholipid syndrome (APS) is an autoimmune disorder that typically presents as venous or arterial thrombosis and/or pregnancy loss. Diagnosing APS can be difficult as its symptoms often resemble those of other diseases. Prompt diagnosis is essential to avoid complications, unnecessary medical procedures, and escalating healthcare costs. Now, a new pair of reagents can enable early diagnosis of APS, one of the hard-to-diagnose autoimmune diseases. Werfen’s (Barcelona, Spain) Aptiva APS Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents are immunoassays that utilize Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. They serve as a diagnostic aid for both primary and secondary APS, in conjunction with other laboratory findings. The Aptiva system is a fully automated, multi-analyte system, representing the latest advancement in high throughput analyzers for autoimmunity and immunology laboratories. Utilizing ...
Acute ischemic stroke, which is the most common type of stroke, occurs due to a lack of oxygen in the brain caused by a blood clot. Currently, there are no blood-based biomarkers that can accurately reflect the acute neuronal damage following a stroke or predict the clinical outcomes for stroke patients. Now, a new study has demonstrated that an ultra-sensitive blood test can reflect brain damage and also predict functional outcomes after acute ischemic stroke. Brain-derived tau (BD-tau), a protein indicative of neuronal breakdown in the central nervous system, particularly in Alzheimer’s disease, has been the focus of recent research. Last year, a team from the University of Gothenburg (Gothenburg, Sweden) developed a novel blood test to measure BD-tau levels. This breakthrough represents a significant step towards creating a tool for tracking and monitoring Alzheimer’s disease progression. In their latest research, this team explored whether BD-tau could also serve as ...
The key to defeating cancer lies in its early and accurate diagnosis. Clinical data underscores this, revealing a significant 50-75% increase in the five-year survival rate when cancers are identified in their initial stages. This is true for various types of cancer, including ovarian cancer, which is notoriously challenging to diagnose. Mass spectrometry has been instrumental in discovering thousands of peptides in the urine of ovarian cancer patients, indicating their potential as biomarkers for the disease. However, the application of mass spectrometry in clinical settings is limited, prompting the need for alternative methods to detect these peptides. Now, a new study has found a novel technique to be effective in identifying specific biomarkers found in the urine of ovarian cancer patients, a development that could eventually aid doctors in diagnosing the disease more accurately. Researchers from Virginia Commonwealth University (VCU, Richmond, VA, USA) employed a combination of gold nanoparticles and ...
Currently, mammography is the standard method for breast cancer diagnosis, but it has several limitations. The primary concern with mammograms is their lack of infallibility. False negatives can occur when normal breast tissue conceals cancer, and false positives may arise from anomalies that resemble cancer but are benign, causing unnecessary anxiety for patients. Additionally, the radiation involved in these tests could potentially contribute to the development of cancer over time. Now, a pain-free, low-cost, sensitive, radiation-free device that can detect breast cancer in urine with a sensitivity of 88.33% could bring about a shift in the diagnostic approach toward this disease. The Blue Box Biomedical Solutions (Barcelona, Spain) has developed an affordable, user-friendly, and portable device that can detect breast cancer using a urine sample. This device, known as the Blue Box, employs an innovative eNose (electronic nose) to detect the smell of urine. It features a chemical sensor array ...
Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
Globally, brain tumors comprise 85%-90% of all primary central nervous system (CNS) tumors, representing approximately 300,000 cases (1.6%) out of the total 19,300,000 annual cancer incidences. They also account for around 250,000 (2.5%) of the total 10,000,000 annual cancer-related deaths. Presently, the standard of care (SoC) for diagnosing intracranial space-occupying lesions (ICSOL) involves histopathological evaluation (HPE) of tumor tissue specimens, which are typically obtained through surgical excision or biopsy. However, surgical resection or biopsy can be particularly challenging for patients with poor performance status, comorbidities, or reluctance to undergo invasive procedures. These procedures carry well-documented risks, including pain, discomfort, intracranial hemorrhage, cerebral edema, infections, and even morbidity and mortality. Now, a simple blood test could help diagnose patients with brain tumors, saving them from undergoing invasive, highly risky surgery. In a world-first, researchers at Imperial College London (London, UK) have proved a new technique for glial tumors including glioblastoma (GBM), ...
Neuroendocrine carcinomas, such as neuroendocrine prostate cancer and small-cell lung cancer, originate in hormone-releasing cells and can develop in various organs, including the prostate and lungs. While they are not the most prevalent cancer type in these organs, they often have a poor prognosis and limited therapeutic options. Current treatments for these cancers include chemotherapy, radiation, and immunotherapy combinations. Neuroblastoma, predominantly found in young children, develops from immature nerve cells, often in the adrenal glands or nerve tissue along the spine, chest, abdomen, or pelvis. Despite treatment efforts, these therapies only extend survival by a few months, underscoring the need for better therapeutic targets and less invasive diagnostic approaches for these malignancies. Investigators from the UCLA Health Jonsson Comprehensive Cancer Center (Los Angeles, CA, USA) have identified UCHL1, a protein found in aggressive neuroendocrine carcinomas and neuroblastoma, as a potential molecular biomarker for diagnosing these cancers and predicting and monitoring ...
The lack of non-invasive methods for monitoring brain status is a significant challenge in psychiatric care. Using genetic material from human blood and lab-grown brain cells, researchers have now made advances in developing a blood test to detect brain-related changes associated with postpartum depression and other psychiatric and neurological disorders. The research by investigators at Johns Hopkins Medicine (Baltimore, MD, USA) focused on tracing brain cell-derived mRNAs in the bloodstream. These extracellular vesicles (EVs), which are tiny sacs containing genetic material, are crucial for cell communication and carry messenger RNA (mRNA) from the brain. This method allows for the detection of changes in gene activity within the brain. The team’s interest in this area grew from an earlier study that found altered EV communication in pregnant women who developed postpartum depression after childbirth. The latest study used the human placenta as a model to identify 26 placental mRNAs in maternal ...
The EST identified 30% of patients with a blood supply/demand mismatch Researchers from King’s College London (KCL) have revealed that the revival of a heart stress test was successful when put to the test against contemporary standards in heart care. Published in the Journal of American College of Cardiology, the electrocardiogram exercise stress test (EST) was accurate in identifying abnormalities in the heart’s blood supply. Previously, the EST was a popular way of assessing patients with angina – attacks of chest pain caused by reduced blood flow to the heart. The test required a patient to exercise on a treadmill or stationary bike while a cardiologist distinguished whether the blood supply to the heart muscle matched the demand during physical stress. However, due to its perceived inaccuracies, the EST test fell out of favour. KCL researchers, however, questioned this after discovering that an abnormal EST was successful in picking up ...
Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
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