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.
Clinical study of graphene-based PCT/CRP test
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
Antimicrobial stewardship
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.”
The role of graphene in the in-vitro test
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
Manufacturing the graphene in-vitro tests
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.”
Plans for series of tests for disease biomarkers
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.
Isala partners with Aidoc to harness combined potential of radiologists and AI
AI, /in E-News /by panglobalIsala 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.”
Aidoc’s AI demonstrates high sensitivity and specificity
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.
New gene therapy appears to cure haemophilia
, /in E-News, Featured Articles /by panglobalA 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 AAV gene therapy
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.”
Immunosuppression
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.
UK company to develop world’s first graphene-based rapid in-vitro diagnostic test
graphene, in-vitro tests, /in E-News, Editors' Picks, Featured Articles /by panglobalConcept 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.
Clinical study of graphene-based PCT/CRP test
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
Antimicrobial stewardship
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.”
The role of graphene in the in-vitro test
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
Manufacturing the graphene in-vitro tests
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.”
Plans for series of tests for disease biomarkers
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.
MENA DIGIHEALTH Conference
, /in Events /by panglobalThe MENA DIGIHEALTH forum will bring together thought leaders from healthcare sector. These leaders will be from both public and private healthcare entities which includes health ministries, private healthcare institutions, digital health experts, researchers and government bodies to share their knowledge and highlight the need for digital health in challenging times. The main objective is […]
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Nerve stimulation promotes resolution of inflammation
, /in E-News /by panglobalIt 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 […]
$25 million awarded to inter-national research team to understand genesis of cancer
, /in E-News /by panglobalA team of researchers co-led by University of California San Francisco’s Allan Balmain, PhD, FRS, has been selected to receive a $25 million Cancer Grand Challenges award to investigate the very early stages of cancer development. Cancer Grand Challenges is a global funding platform, co-founded by Cancer Research UK (CRUK) and the National Cancer Institute […]