The progressive neurodegenerative disease affects more than 55 million people globally Innovate UK has awarded £4m through its Contracts for Innovation to four UK companies for research into dementia diagnosis. As part of the Bio-Hermes-002 study led by the US-based Global Alzheimer’s Platform Foundation (GAP) in partnership with Novo Nordisk, the organisations will evaluate blood-based and digital innovative biomarkers for the neurological condition. Affecting more than 55 million people globally, which is expected to triple by 2050, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. The study aims to explore whether these biomarkers can predict the extent of tau and amyloid brain pathology and potentially provide more efficient and less invasive alternatives to the current gold standard for dementia diagnoses: positron emission tomography brain imaging. The project will involve 1,000 participants who are cognitively normal, have mild cognitive impairment or ...
The serious, rare condition is responsible for up to 7% of all neonatal deaths globally Researchers from the University of Birmingham are developing a new blood-free test to help identify children across the Global South missing immunity to tetanus and other essential vaccines. Supported by £1.1m of funding by the Medical Research Council, the low-cost, non-invasive saliva lateral flow test can potentially reveal whether a person has protection against tetanus within just 15 minutes. Estimated to be responsible for up to 293,000 deaths worldwide every year, according to the European Centre for Disease Prevention and Control, tetanus is a serious disease of the nervous system caused by a toxin-producing bacterium, Clostridium tetani, and is responsible for up to 7% of all neonatal deaths globally. Newborn tetanus is a rare condition that occurs in infants most often within the first ten days of life, resulting from an infection in the umbilical ...
The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs. bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory ...
The influenza virus represents a significant public health concern, annually causing epidemics with high morbidity and mortality rates. The virus is known for its high mutation rate and the existence of multiple subtypes, which require varied clinical approaches. Consequently, there is a critical need for an accurate, rapid, and portable method to differentiate between influenza virus subtypes to manage virus transmission and inform clinical treatment decisions. Researchers have now developed a spatial encoding of a centrifugal microfluidic disc-integrated smartphone-controlled (SEDphone) platform for detecting influenza virus subtypes. In a study, researchers from the Hefei Institutes of Physical Science of the Chinese Academy of Sciences (Anhui, China) developed a novel approach that combines Loop-mediated Isothermal Amplification (LAMP) with CRISPR/Cas12a technologies for rapid and accurate detection of various influenza viruses. This method amplifies target sequences using LAMP and detects them through CRISPR/Cas12a-mediated trans-cleavage activity, thus cleaving reporter probes and emitting fluorescent signals. ...
By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
By Don Tracy, Associate Editor JAMA study aims to discover how weight loss differs between patients receiving tirzepatide compared with semaglutide among a clinical population of overweight of obese adults. Tirzepatide and semaglutide are both GLP-1 agonists that have demonstrated the ability to offer significant weight reduction in patients with obesity, with or without type 2 diabetes (T2D). There are currently no real-world data comparing the effectiveness of the two in treating overweight or obese populations. In a cohort study recently published in JAMA Internal Medicine, researchers set out to provide a head-to-head comparison of these medications in a real-world clinical setting, focusing on weight loss outcomes and gastrointestinal adverse events (AEs). The study included 18,386 patients who were new users of tirzepatide or semaglutide with overweight or obesity, regardless of T2D status. Additionally, patients were selected based on their electronic health records data and propensity-score matched to ensure comparability. ...
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
Metagenomic next-generation sequencing (mNGS) is a shotgun sequencing method where all the nucleic acid (DNA and RNA) in a clinical sample is sequenced at a very high depth, 10-20 million sequences per sample. This technique is applicable to various clinical samples, including cerebrospinal fluid, plasma, respiratory secretions, urine, stool, or tissue. A single mNGS test can detect sequences from all pathogens—viruses, bacteria, fungi, and parasites—thereby aiding in identifying the potential cause of a patient’s infection. Now, data from a new study underscores the effectiveness and diagnostic capabilities of mNGS in diagnosing infectious diseases such as meningitis, encephalitis, and myelitis in both adults and children. mNGS technology, originally developed at the University of California, San Francisco (UCSF, San Francisco, CA, USA) and exclusively licensed to Delve Bio (Boston, MA, USA), has been hailed as the future of infectious disease diagnostics, enabling physicians to avoid frustrating cycles of testing for patients battling ...
Multiple Sclerosis (MS) is an autoimmune, inflammatory, and neurodegenerative condition where axonal loss leads to irreversible neurological damage and disability. Currently, approximately 2.8 million people globally are affected by MS, though this figure is likely underestimated due to underdiagnosis in underserved and remote areas lacking adequate neurological care and imaging facilities. While no cure exists for MS, available treatments aim to reduce the frequency of relapses, which are linked to nerve cell damage and the progression of the disease. There is a critical need for an accessible, affordable, and accurate blood test that can detect early signs of neuronal injury and disease activity. The neurofilament light chain (NfL) protein has been identified as a key biomarker for nerve cell damage. Now, a new blood test that measures levels of NfL could facilitate earlier detection of MS-related neuronal injury and improve disease management. Siemens Healthineers (Forchheim, Germany), in collaboration with Novartis ...
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