Search Results for “diagnostic” – Page 39 – media

Benchtop Analyzer Promises 1-Hour UTI Detection and Antibiotic Sensitivity Indication

More than 400 million cases of urinary tract infections (UTIs) are reported every year across the world. The gold standard for diagnosing UTIs and planning a treatment course depends on rapid dipstick tests and clinical diagnostic analysis. However, dipsticks have low specificity and can yield false positives, resulting in the overuse of antibiotics. Additionally, clinical tests have a lengthy turnaround time and offer 80% accuracy, resulting in physicians opting for the wrong course of treatment. Now, a benchtop analyzer with the ability to accurately identify the causative bug and the right antibiotic in under an hour could be a game changer for UTI diagnosis. Astek Diagnostics (Baltimore, MD, USA) is developing the JIDDU benchtop analyzer to improve UTI diagnosis through rapid, one-hour turnaround times and an unprecedented 96% accuracy. Leveraging a novel method for antibiotic susceptibility testing (AST), JIDDU rapidly detects bacterial infections in urine samples, assesses infection severity, and ...
- Source: drugdu
- 149
- January 16, 2024
Hundreds of chemicals linked to breast cancer risk identified in new study

In a recent study published in the journal Environmental Health Perspectives, researchers examined published studies investigating the genotoxicity of potentially carcinogenic chemicals and their roles in inducing mammary tumors and activating progesterone or estradiol signaling. The researchers aimed to identify chemicals that could present breast cancer risk to humans. Background Recent statistics indicate that breast cancer is the most prevalent form of cancer and the major cause of cancer-related mortality among women across the world. In the United States (U.S.), the lifetime risk of women developing breast cancer is double that of the risk of developing lung cancer. Furthermore, the incidence of breast cancer among younger women is increasing, with mortality rates due to breast cancer among women between the ages of 20 and 49 years being double that of other forms of cancers affecting individuals of both sexes. A nine-year assessment since 2010 also indicates that the diagnostic rate ...
- Source: drugdu
- 214
- January 16, 2024
Menstrual Blood Testing Technology Eliminates Need for Finger Prick or Lab Blood Draw

Traditional methods of blood testing require invasive procedures administered by medical professionals, and can be time-consuming as well as expensive. Not everyone has the time, access, and financial means to get laboratory results for blood work, however, billions of women globally have their period every single month. Until now, menstrual samples had never previously been explored as a diagnostic source for health information. Now, for the first time, a safe and simple technology allows menstrual blood samples to be used as an alternative to traditionally collected venous blood draws. This breakthrough provides an opportunity for testing important biomarkers for millions of menstruating women across the world. Qvin (Menlo Park, CA, USA) has proved the clinical relevancy of menstrual blood for several important biomarkers. The company’s Q-Pad technology uses menstrual blood to gain health insights in a non-invasive, convenient manner and can be used for testing anywhere in the world. The ...
- Source: drugdu
- 95
- January 13, 2024
New Blood Test Identifies Neuroendocrine Subtype of Advanced Prostate Cancer

Roughly 10-15% of individuals with metastatic castration-resistant prostate cancer (CRPC) eventually develop neuroendocrine prostate cancer (NEPC), a challenging cancer subtype. This transformation is marked by a change from androgen-dependent cancer cells to those that no longer respond to androgens. Diagnosing NEPC typically involves a biopsy from a metastatic tumor, but this can be uncertain due to timing issues and the heterogeneous nature of metastatic tumors. Now, researchers have developed a blood test that can reliably detect NEPC and differentiate it from CRPC-adenocarcinoma (CRPC-adeno). In previous research, an international team of researchers from Dana-Farber Cancer Institute (Boston, MA, USA and the University of Trento (Trento, Italy) examined biopsy tissue samples to identify genetic and epigenetic shifts accompanying this shift from cancer cells that are dependent on hormones called androgens to cancer cells that no longer even recognize androgens. They discovered distinctive genome-wide epigenetic alterations, particularly in DNA methylation, that differentiate CRPC-adeno ...
- Source: drugdu
- 100
- January 13, 2024
Multiplexed POC Testing IVD Solution Performs Molecular and Immunoassays from Various Body Fluids on Single Platform

A hybrid in vitro diagnostics (IVD) solution for multiplexed point-of-care testing (xPOCT) can perform both molecular and immunoassays from several body fluids on a single platform. The hybrid and scalable technology aims to deliver lab-comparable test results in a single patient encounter, significantly reducing the diagnostic timeline. Picodya’s B-Matrix diagnostic system is the world’s first POC hybrid solution that can run IVD tests, both immunoassays and molecular assays on the same device at lab-comparable quality, on multiple patient samples, simultaneously within minutes. The B-Matrix is designed to minimize turnaround time, and deliver better outcomes while lowering costs. The B-Matrix is powered by Picodya’s proprietary PicoFluidic technology which enables the system to operate at high capacity testing for a panel of markers simultaneously, using just pico volumes of reagents and controls. This allows for ultra-fast results within as quickly as 15 minutes and at a fraction of the cost for comparable ...
- Source: drugdu
- 164
- January 12, 2024
MHRA sets out regulatory roadmap to support safe access to medical technology

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out a regulatory roadmap to enable safe access to medical technology, including artificial intelligence (AI) and diagnostics. The Roadmap Towards the Future Regulatory Framework for Medical Devices will support the development of new regulations that will prioritise patient safety and help ensure individuals continue to have access to the devices they need without delay, while enhancing the UK’s position as “a world-leading environment for medical technology innovators,” the MHRA said. The roadmap is also set to offer “significant new opportunities for patients and healthcare” by enhancing the UK’s ability to benefit from advancing medical technology such as implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. Dr Laura Squire, the MHRA’s MedTech regulatory reform lead and chief officer of healthcare, quality and access, said: “Today’s exciting medical technology advances offer important new opportunities for ...
- Source: drugdu
- 96
- January 12, 2024
Multi-Cancer Early Detection Solution to Address Unmet Medical Needs in Clinical Diagnosis

Early detection, diagnosis, and treatment can significantly improve the survival and quality of life of cancer patients. Tumors continuously release fragmented genomic DNA into the bloodstream, although existing testing methods may find the signal too weak to be picked up in the early stages. Now, a revolutionary multi-cancer early detection solution leverages highly sensitive multi-omics technology to detect early cancer signals as well as predict the tissue of origin (TOO). Geneseeq Technology Inc.’s (Toronto, Canada) CanScan multi-cancer early detection solution is designed to enhance the early detection, diagnosis, and treatment of various cancers. This innovative solution harnesses the power of low-depth whole-genome sequencing (WGS) applied to circulating cell-free DNA (cfDNA) from a single tube of peripheral blood. It efficiently extracts genetic and fragmentomic features to identify early cancer signals with a high specificity of 99% and accurately predicts the TOO of cancers, thereby informing subsequent diagnostic and treatment strategies. Particularly ...
- Source: drugdu
- 168
- January 11, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 124
- January 11, 2024
New Biomarkers for Diabetic Kidney Disease to Improve Diagnosis and Monitoring

Diabetic kidney disease (DKD) is a major microvascular complication arising from type 2 diabetes mellitus (T2DM), leading to end-stage renal disease (ESRD). Despite advancements in treatment options such as hyperglycemic and blood pressure control and renin-angiotensin system blockades, DKD continues to prevail at alarming rates. Clinically, DKD often progresses from microalbuminuria to macroalbuminuria, marked by increased levels of albumin in the urine and an initial hyperfiltration phase followed by a gradual decline in renal function. However, variations in clinical presentations and progression rates to ESRD have been noted in recent studies. As scientific understanding evolves, the need for specific biomarkers for DKD has become increasingly vital. Now, an analysis of urinary and exosome proteome profiling by a team of scientists has led to the discovery of biomarkers for DKD, offering the potential for early diagnosis and treatment. The research carried out by scientists at the Chinese Academy of Sciences (Beijing, ...
- Source: drugdu
- 130
- January 10, 2024
Nanowear gets FDA clearance for undergarment that estimates blood pressure

Dive Brief Nanowear has received 510(k) clearance for AI-enabled software that allows its wearable undergarment to estimate blood pressure. The Food and Drug Administration decision covers software that processes electrocardiogram (ECG) data, heart sounds and thoracic impedance captured by the Simplesense wearable device to monitor blood pressure at home, in healthcare facilities and during medical research. Nanowear is pitching the software as the “first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic.” The company cited Biobeat Technologies’ wrist and chest monitor as a predicate blood pressure device in its 510(k) filing. Dive Insight Simplesense is a cloth-based undergarment that wraps around the wearer’s torso and over one shoulder. The medical device features two ECG leads, plus sensors for recording heart sounds and activity, and for measuring respiration rate through thoracic impedance. Nanowear made the device to enable physicians and researchers to remotely capture data on patients without disrupting their lives. ...
- Source: drugdu
- 176
- January 9, 2024

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