Cambridgeshire, UK-based Paragraf, the first company in the world to deliver a scalable approach to graphene electronic device manufacturing, has announced a plan to develop a new generation of graphene-based, in-vitro diagnostic products that will give results within a few minutes.
Aidoc, a leading provider of healthcare AI solutions, has signed a strategic agreement with Isala Hospital, one of the largest non-academic medical facilities in the Netherlands. Isala’s implementation of the AI Care platform, which includes three of the ten AI algorithms of Aidoc’s suite of CE-marked and FDA-cleared AI solutions, will empower the hospital to […]
Brain cortical surfaces are represented by triangular meshes. The surface area of each vertex (e.g., the red point) is one third of the total surface area of its one-ring neighboring triangles (the red hexagon). Credit: Gang Li Lab, UNC School of Medicine
Scientists at the University of North Carolina (UNC) School of Medicine have mapped the surface of the cortex of the young human brain with unprecedented resolution, revealing the development of key functional regions from two months before birth to two years after.
The new cortical development mapping, reported online in the Proceedings of the National Academy of Sciences, represents a valuable resource for further research on brain development and offers a powerful new approach to the study of brain-development conditions such as autism and schizophrenia.
“These results provide an important reference for exploring and understanding the dynamics of early brain development,” said study senior author Gang Li, PhD, associate professor of radiology at the UNC School of Medicine.
The study’s first author was Ying Huang, a PhD candidate in Li’s laboratory.
The cortex is a sheet of brain cells that wraps around much of the rest of the brain. The most evolutionarily advanced brain region, it is proportionately larger in humans than in other mammals, and is responsible for higher, distinctively human functions including language abilities and abstract reasoning.
The third trimester of pregnancy through the first two years of life is the most dynamic period in cortical development. The cortex thickens markedly during this interval, and grows at an even faster pace in terms of surface area, by forming complicated cortical folds.
Disruptions to cortical thickening and expansion in this phase have been linked to autism and schizophrenia. However, neuroscientists haven’t had as detailed an understanding of this developmental phase as they would like. In particular, they’ve had a need for more comprehensive, high-resolution mapping, across the foetal-to-toddler age range, that divides or “parcellates” the developing cortex into distinct regions with their own growth rates – especially surface area growth rates.
In the study, Li and colleagues performed just such a mapping. They first gathered a set of 1,037 high-quality magnetic resonance imaging (MRI) scans of infants in the third-trimester-to-two-year age interval. The scans came from two other research projects, the UNC/UMN Baby Connectome Project (BCP) and the Developing Human Connectome Project. The team analyzed the scan data using state-of-the-art, computer-based image-processing methods, essentially dividing the cortical surface into a virtual mesh containing thousands of tiny circular areas, and calculating the surface expansion rate for each of these areas.
The analysis didn’t start with assumptions about the locations of brain structures or functional regions, but this regionalization of the brain became evident anyway from the resulting maps, based solely on the different rates at which areas of the surface expanded. In all, the researchers defined 18 distinct regions, which they found correlated well with what is already known about the developing cortex’s functional regions.
“All these regions show dramatic expansion in surface area during this developmental window, with each region having a distinct trajectory,” Li said.
The maps revealed that each region tended to have the same developmental path as its counterpart in the cortex’s opposite hemisphere. Sex differences were apparent too. Even when controlling for sex differences in overall surface area – male brains having greater area – there remained differences in multiple regions. For example, the medial prefrontal region in the left hemisphere, which is believed to host important functions such as attention and working memory, became proportionately larger in males early in the second year of postnatal life.
The analysis also showed that the patterns of cortical surface area expansion in this early period of life were very different from the patterns of cortical thickness development, suggesting that these two measures of brain development involve distinct mechanisms.
All in all, Li said, the mapping provides fundamental new insights into brain development.
He and his team now plan to extend this approach with MRI scan datasets that start at earlier ages and end at older ones. They also hope eventually to study scan datasets covering children who have autism-spectrum or other neurodevelopmental conditions. Such analyses might offer not only clues to the origins of these conditions, but also the identification of early signs or biomarkers, which in the future could be used to administer early and more effective treatments.
Ying Huang, Zhengwang Wu, Fan Wang, et. al. “Mapping developmental regionalization and patterns of cortical surface area from 29 post-menstrual weeks to 2 years of age.” PNAS, August 8, 2022. doi: https://doi.org/10.1073/pnas.2121748119
The digital information services on offer at this year’s MEDICA & COMPAMED – to be held November 14-17 in Düsseldorf, Germany – will enable visitors to prepare in advance for meetings with exhibitors.
The exhibitor profile is at the heart of the exhibiting companies’ digital trade fair presence, and is thus an important tool for companies that want to be found by customers, both digitally and on-site. The relaunch of the exhibitor profiles was rolled out from the middle of July across all Messe Düsseldorf online portals.
“Companies need to present themselves and their products to their best advantage, both live at the trade fair and online. The new exhibitor profile enables them to do this,” explained Wolfram N. Diener, CEO of Messe Düsseldorf. “We have reinvested in platforms that we can provide to our customers both in-person and digitally. Our trade fairs are open 365 days a year on our online portals. They form the first point of contact for their relevant sectors. In order to provide our customers with the greatest level of benefit, we maintain a regular exchange and continue the development our digital services, such as the online portals.”
The revamped exhibitor profile has a modern, clean design and has been further optimised for mobile devices. Users can filter the offers listed there according to their personal interests. This means that companies, their products, trade fair events and company news can be found simply and quickly. It is also easier to contact companies and create personalised favourite lists at the click of a button, enabling visitors to prepare for the trade fair with very little effort.
Digital discussion circles
The MEDICA DEEP DIVE digital discussion circles, held in English, have been conceived as a warm-up, so that content for trade fair participation can be prepped in a purposeful manner. They bring relevant, trending topics from the healthcare sector into focus. It starts on September 22, with “Diagnostics for infectious diseases”, in which current innovations and developments in point-of-care diagnostics are among the central topics. The topics of “Artificial Intelligence/big data in a medical setting” and “The smart hospital” follow soon afterwards. The moderated online discussion circles present cutting-edge expert knowledge from the industry, clinical practice and science in 45-minute segments and can be streamed on the industry portal, MEDICA Deep Dive.
Bookings increase
Looking at the trend for exhibitor bookings suggests that participation at MEDICA 2022 and at the parallel event COMPAMED 2022, the international leading trade fair for the supplier sector for the medical technology industry, will exceed the participation level at the events in 2021.
German Hospital Conference
Of several events on the programme at MEDICA, the 45th German Hospital Conference is the leading event for top management of German clinics. The programme also includes the DiMiMED Conference on Disaster and Military Medicine, and the MEDICA MEDICINE + SPORTS CONFERENCE.
New HEPA filters keep air clean
Along with well-developed programme planning, technical equipment also ensures the best conditions for MEDICA 2022 and COMPAMED 2022. In the first half of 2022, the entire Düsseldorf trade fair and congress centre was fitted with HEPA filters. These are currently the most effective form of air treatment technology and are also used in operating theatres and intensive care wards. HEPA filters remove 99.9% of the viruses, bacteria and other particles from the air. The purified air is then fed back into the room.
“In combination with high-performance air conditioning systems, the filters in our huge halls ensure that our guests can attend the trade fair with a sense of security.” explained Christian Grosser, Director Healthcare & Medical Technologies of Messe Düsseldorf.
A comprehensive assessment of scientific literature has uncovered empirical evidence that more than 58% of human diseases caused by pathogens, such as dengue, hepatitis, pneumonia, malaria, Zika and more, have been – at some point – aggravated by the hazards of climate change. That alarming finding is the result of a research paper published on August 8 in Nature Climate Change by a team of researchers from the University of Hawaiʻi at Mānoa.
The researchers carried out a systemic search for empirical examples about the impacts of 10 climatic hazards sensitive to greenhouse gas (GHG) emissions on each known human pathogenic disease. These hazards included warming, drought, heatwaves, wildfires, extreme precipitation, floods, storms, sea level rise, ocean biogeochemical change, and land cover change.
Combining two authoritative lists of all known infections and pathogenic diseases that have affected humanity in recorded history, researchers then reviewed more than 70,000 scientific papers for empirical examples about each possible combination of a climatic hazard impacting each of the known diseases.
The research revealed that warming, precipitation, floods, drought, storm, land cover change, ocean climate change, fires, heatwaves and sea level changes were all found to influence diseases triggered by viruses, bacteria, animals, fungi, protozoans, plants and chromists. Pathogenic diseases were primarily transmitted by vectors, although case examples were also found for waterborne, airborne, direct contact and foodborne transmission pathways.
Ultimately, the research found that more than 58% (218 out of 375) of known human pathogenic diseases had been affected at some point, by at least one climatic hazard, via 1,006 unique pathways.
“Given the extensive and pervasive consequences of the COVID 19 pandemic, it was truly scary to discover the massive health vulnerability resulting as a consequence of greenhouse gas emissions,” said Camilo Mora, geography professor in the College of Social Sciences (CSS) and lead author of the study. “There are just too many diseases, and pathways of transmission, for us to think that we can truly adapt to climate change. It highlights the urgent need to reduce greenhouse gas emissions globally.”
An interactive web-page showing each connection between a climatic hazard and a disease case was developed by the research team. The tool allows users to query specific hazards, pathways and disease groups, and see the available evidence.
Researchers also found that, while the great majority of diseases were aggravated by climatic hazards, 63 out of 286 diseases diseases were diminished by some climatic hazards, although 54 of them were at times also aggravated by other climatic hazards; only nine pathogenic diseases were exclusively diminished by climatic hazards. Warming, for example, appears to have reduced the spread of viral diseases probably related to unsuitable conditions for the virus or because of a stronger immune system in warmer conditions.
“We knew that climate change can affect human pathogenic diseases,” said co-author Kira Webster, CSS geography PhD student. “Yet, as our database grew, we became both fascinated and distressed by the overwhelming number of available case studies that already show how vulnerable we are becoming to our ongoing growing emissions of greenhouse gases.”
Isala Hospital, Netherlands
Aidoc, a leading provider of healthcare AI solutions, has signed a strategic agreement with Isala Hospital, one of the largest non-academic medical facilities in the Netherlands. Isala’s implementation of the AI Care platform, which includes three of the ten AI algorithms of Aidoc’s suite of CE-marked and FDA-cleared AI solutions, will empower the hospital to sustain high quality care and scale AI operations as needed.
Research conducted with Aidoc’s solutions shows that when utilized in clinical settings they have had a positive impact on numerous indicators, such as turnaround time, efficiency, and emergency department (ED) throughput.
Under the partnership, Isala will integrate Aidoc’s AI algorithms for triage and notification of intracranial haemorrhage (ICH), pulmonary embolism (PE), and c-spine fractures. Isala is also a member of the Netherland’s seven top clinical hospitals, referred to as mProve, whose mission is to provide patients with better care every day. The inclusion of Aidoc’s AI further consolidates Isala’s position as a front-runner in medical and technical innovation in Europe, while striving to maintain high quality care amid the surging volumes that will continue in the foreseeable future.
“Imaging volumes continue to rise. Therefore, we need a clear plan on how AI technology can support radiologists to manage the increasing workload. AI has proven to offer high value by reducing turnaround time, increasing the radiologists’ confidence and reducing variability of quality,” said Dr Martijn Boomsma, radiologist at Isala and a champion of AI.
“In Aidoc we’ve found the perfect partner, a vendor who is willing to test and demonstrate the performance and is constantly working on improving their algorithms,” Dr Rogier van Dijk, radiologist at Isala and also a champion of AI, added. “At Isala, we have certainly found that value in the ability of Aidoc’s AI platform to complement our radiologists’ strengths. AI offers us a high degree of comfort amid periods of both higher and lower imaging volumes, and especially during night shifts. Beyond radiology, we also observed its ability to make a positive impact on the post-diagnosis patient pathway.”
In clinical settings, Aidoc’s AI has demonstrated high sensitivity and specificity and the ability to complement radiologist’s strengths. In a study evaluating performance as a complement to radiologists, Aidoc’s AI showed high sensitivity and negative predictive values while the radiologist demonstrated high specificity and positive predictive value, with 70% of participant radiologists stating that AI could “improve diagnostic comfort”.
In another study, conducted by Unfallkrankenhaus Berlin, researchers showed the potential of Aidoc’s AI and physicians together could increase triaging of positive intracranial haemorrhage cases by 12.2%. Isala evaluated Aidoc’s algorithm for c-spine fractures on a validated database of 2,331 CT scans and showed the potential value of the AI as a concurrent reader by increasing the total number of fractures identified by a radiologist by 13% (ECR 2022 oral presentation).
“We are delighted to have a strategic partner like Isala, who truly sees the value of implementing AI at scale in radiology workflows and the downstream impact it can make,” said Alexander Boehmcker, Aidoc’s VP Europe. “AI is a tool that augments the radiologist and so when paired, the two complement each other and raise diagnostic efficiency. Hospitals like Isala with their visionary leadership are forging a new path, showing how AI will play a pivotal role in the future of hospital care in Europe through rigorous clinical research and perpetually proving AI’s valuable role.”
The Aidoc AI Care platform is home to 16 CE-marked radiology AI solutions – 10 developed in-house and six third-party algorithms – and multidisciplinary team coordination solutions, all driven by the underlying AI OS. Aidoc’s AI Care platform impacts patient care in more than 1,000 medical facilities worldwide, with many located in Europe.
A Phase I/II multi-centre clinical trial, called B-AMAZE, has found that a single gene therapy injection dramatically reduces the bleeding risk faced by people living with haemophilia B and enabled trial participants to stop their regular blood clotting factor replacement therapy.
The study is published in the July 21, 2022 issue of the New England Journal of Medicine.
Of the 10 male patients selected to take part in the trial, all showed dose-dependent increases in factor IX levels. At a median follow-up of 27.2 months, sustained factor IX activity was observed in all the patients except one.
Haemophilia B is a rare and inherited genetic bleeding disorder caused by low levels of the blood clotting factor IX (FIX) protein.
The gene responsible for making FIX protein is located on the X chromosome, so the severe form of haemophilia B is much more common in men.
Currently, patients with haemophilia B need to inject themselves regularly – usually weekly – with recombinant FIX, a regular replacement therapy to prevent excessive bleeding. Despite advances in treatment, patients may continue to see debilitating joint damage.
The B-AMAZE trial and the related long-term follow up study found that one-time treatment with FLT180a led to sustained production of FIX protein from the liver in nine of ten patients, across four different dose levels. They no longer required weekly injections of FIX protein. They are also all enrolled in the long-term follow up study to assess safety and durability of FIX expression for 15 years.
FLT180a (verbrinacogene setparvovec) is a liver-directed adeno-associated virus (AAV) gene therapy. AAV gene therapy works by using a packaging from the proteins found in the outer membrane of the virus, to deliver a functional copy of a gene directly to patient tissues – in this case the liver. Newly synthesised proteins – in this case the FIX protein – are released into the blood. A one-time infusion can achieve long-lasting effects.
Lead author Professor Pratima Chowdary of the Royal Free Hospital, UCL Cancer Institute, said: “Removing the need for haemophilia patients to regularly inject themselves with the missing protein is an important step in improving their quality of life. The long term follow up study will monitor the patients for durability of expression and surveillance for late effects.”
Patients in the trial needed to take immune suppressing drugs over several weeks to several months, to prevent their immune systems from rejecting the therapy, and all reported known side effects. While the treatment was generally well tolerated, all patients experienced some form of adverse events, with an abnormal blood clot in one who received the highest FLT180a dose and had the highest levels of FIX protein.
Freeline Therapeutics co-founder Professor Amit Nathwani (UCL Medical Sciences), who co-authored the study, said: “Gene therapy is still a young field that pushes the boundaries of science for people with severe genetic diseases.
“The B-AMAZE long-term data add to the growing body of evidence that gene therapy has the potential to free patients from the challenges of having to adhere to lifelong therapy or could provide treatment where none exists today.”
Pamela Foulds, MD, Chief Medical Officer of Freeline, said: “The B-AMAZE long-term data continue to support our confidence that a single dose of FLT180a could protect people with haemophilia B from bleeding and the need for lifelong FIX replacement through durable expression of FIX at protective levels.”
The Phase I/II trial was sponsored by University College London and funded by Freeline Therapeutics, a clinical-stage biotechnology company developing AAV vector-mediated systemic gene therapies.
A Phase I/II dose-confirmation trial of FLT180a called B-LIEVE to finalize a dose for a Phase 3 pivotal trial is in progress.
Concept image of Paragraf diagnostic handset and test cartridge — © Paragraph 2022
Cambridgeshire, UK-based Paragraf, the first company in the world to deliver a scalable approach to graphene electronic device manufacturing, has announced a plan to develop a new generation of graphene-based, in-vitro diagnostic products that will give results within a few minutes.
With the support of a £550,000 Biomedical Catalyst grant award from Innovate UK, Paragraf initiated a two-year programme to develop a proof-of-concept combined PCT (procalcitonin) and CRP (C-reactive protein) test, on a single panel. On March 1 this year Paragraf raised US$60 million in a Series B financing round.
The company is collaborating with the universities of Liverpool, Manchester and Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust and Manchester University NHS Foundation Trust (MFT), on the development.
A clinical study of the combined PCT/CRP test will be delivered at MFT’s Diagnostics and Technology Accelerator (DiTA) in mid-2023. DiTA aims to address unmet needs, transform patient care and improve efficiency within the NHS, by facilitating the rapid translation and adoption of new innovations into the healthcare system. The project is expected to be completed by the end of May 2024.
Paul Dark, Professor of Critical Care Medicine at The University of Manchester, and Honorary NHS Consultant at Salford Royal, part of Northern Care Alliance NHS Foundation Trust, said: “We expect to show that our proposed acute inflammatory marker test will have the capability to deliver accurate results for emergency patient care within a few minutes, from a small sample of blood. The accuracy of the test is envisaged to be at least comparable with hospital centralised lab-based immunoassay tests which can take hours to provide results back to emergency services.”
Prof. Dark also leads the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC), Respiratory Non-fungal Infections Programme, which is focused on providing more accurate, rapid diagnosis for patients with severe respiratory infections.
Malcolm Stewart, Paragraf Diagnostics Business Development Director
Malcolm Stewart, Paragraf Diagnostics Business Development Director, said: “This graphene-based diagnostic test is expected to become the first test in the world to give clinicians the ability to identify patients who need an antibiotic treatment within the space of a regular 15-minute clinic appointment. It encourages antimicrobial stewardship by giving clinicians the insight into when not to prescribe antibiotics as the test result differentiates viral from bacterial infections.”
Commenting on the role of graphene in the test, Stewart explained that graphene enhances the test by having the ability to detect very low levels of the target protein (in this case). “Graphene is one of the most conductive substances ever discovered. The almost immediate electrical conductivity change in the graphene when only picogram levels of the target (in this case PCT) are detected is the difference the graphene makes. Simply put, graphene allows us to detect much lower concentrations of target analytes and in single digit minutes than is conventionally possible – and in a piece of equipment that will be handheld in size.
“We can make the graphene into chip-like devices – called graphene field effect transistors (GFETS) – which allow us to detect multiple analytes on one chip, a technique called multiplexing. This first test we are working on will detect two analytes on one chip – PCT and CRP. In future, tests we will be multiplexing more than six analytes on one chip in the cartridge.
“Graphene is also biocompatible meaning that we can deposit samples without having to pre-prepare them. So in this case, for the PCT/CRP test, we will only require a couple of drops of blood directly into the test cartridge. The reduction in pre-analytical errors is vital for tests like this one being used in critical care areas where time to result is important. Once this test is being used in primary care the lack of pre-preparation of the sample makes the test feasible in a GP surgery or even in a patient’s home,” Stewart explained.
Enitan Carrol, Professor of Paediatric Infectious Diseases at the University of Liverpool, reiterated this point: “This technology reduces the time and complexity of sample preparation which, together with its rapid measurement speed, provides clinicians with accurate results in a timeframe that allows immediate decisions to be made on antimicrobial prescribing. This is especially important for the treatment of children and neonates.”
Paragraf
Explaining the manufacturing process, Stewart said: “As we scale up our business, the graphene will be deposited on to larger wafers – 20 or 30cm diameter – in the future. We then make GFETS from the wafers.
“Our process is called MOCVD (metal oxide chemical vapour deposition) and is not unique to us. But the way we do it and the ingredients we use makes it unique. We can make graphene that is contamination free, because or graphene is directly formed on the wafer rather than transferred from another metal like copper in other graphene manufacturing processes.
“We believe we have a technique that is scalable to millions of chips a year when we are manufacturing our chips on 30cm wafers.”
Paragraf plans to deliver a series of high sensitivity, rapid tests for disease biomarkers in areas including cardiovascular disease, oncology, and infectious diseases.
The ambition is to develop a comprehensive suite of tests that could be used in almost any environment or healthcare setting. The tests are designed to provide ultra-fast answers to diagnostic challenges and to create a complete diagnostic toolkit at the point of care.
LifeArc and the UK Dementia Research Institute (UK DRI) have launched a new partnership to accelerate development of new diagnostic tests, treatments, and devices from scientific research discoveries to benefit people with dementia. Around 900,000 people in the UK are living with dementia.
It is known that the nervous system communicates with the immune system and can regulate inflammation in the body. Now scientists at Karolinska Institutet in Sweden have shown how electrical activation of a specific nerve can promote healing in acute inflammation. The finding, which is published in the journal PNAS, opens new ways to accelerate […]
April 2024
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