Our CKD Screening Prioritizer is a registered medical device.
Our Chronic Kidney Disease Screening Prioritizer (CSP) has received a UKCA marking and regulatory approval meaning it is a registered medical device in the UK.
UKCA marking is a certification mark that indicates that a product meets the safety, health, and environmental protection standards set by the UK government. In addition, regulatory approval confirms that Gendius has met all the requirements and standards set by the regulatory bodies that oversee the industry. This approval is not only a sign of credibility it allows the expansion of our CSP product into the UK market.
Our CSP product is a digital pre-screening solution that risk stratifies patients to enable precision screening. In early CKD diagnosis and intervention are key, with the often silent and undiagnosed disease, screening is vital to help identify patients. Our solution makes screening smarter by understanding the patient and the system needs. With no laboratory test required our solution is globally scalable and supports clinical decision-making. Read more about our product here.
This is a significant accomplishment that demonstrates Gendius’ commitment to compliance and quality assurance. This approval would not have been possible without our in-house expert in Medical Device Quality and Regulatory compliance Ali Borazjani and the incredible hard work of the wider team.
Ali has a proven track record of successful projects for market-leading medical device companies. With his expertise and experience, Ali is a valuable asset to us here at Gendius as we look to ensure compliance and bring safe and effective products to market.
After this success, Ali and the rest of our team are now focused on achieving CE approval, followed by FDA approval, as the next steps on our regulatory roadmap.
Extending regulatory approval outside of the UK market means that patients worldwide can benefit from our globally scalable CSP solution.
This achievement marks a major milestone in Gendius’s journey towards improving patient lives and reducing the burdens faced by healthcare systems worldwide.
We hope to updating you with more good news again shortly.
2022: A year in Review
2022 was a year full of innovation, resilience, and creativity
Gendius was formed with a mission to help people understand and manage their diabetes better. As the company has evolved, so has our focus. In 2020, we expanded our journey of looking at how data can be used to improve patient lives by bringing in data science expertise.
Whilst we had established collaborations with academic partners at the University of Nottingham and the University of Manchester, we realised that to meet our full potential, we needed to have our own internal team of data experts. Pairing good-quality data with expertise was our obvious next step in changing the landscape of diabetes care.
Consequently, we have been expanding and developing our comprehensive, rich metabolic data set throughout the year; we now have over 100 UK primary care practices that share pseudonymised patient data to support our vision. Alongside this, our data science team was born. With two postdoctoral health data scientists, we have managed to hit the ground running on our data science pathway, leading us to our most exciting innovation of the year: the CKD Screening Prioritizer.
The CKD Screening Prioritizer was developed by our data science team, published in a peer-reviewed journal, validated across global datasets and presented at international expert conferences. Its overwhelming performance compelled us to build a platform that can be used across global healthcare services. We are now in the implementation phase, where clinics and patients will be provided access to the tool, supported by AstraZeneca.
Building this has given us a clear insight into the land of opportunity in supporting the care of people with chronic diseases. It has demonstrated how our team are well suited to develop solutions in this space, indicated where we can help patients the most and motivated our 2023 priority projects. The work we are doing is ultimately about saving lives and reducing the ever-growing cost burden that healthcare systems face, globally.
Reflecting our Values & Vision
The creative team at Gendius evolved our core brand identity at the start of 2022 to create alignment with the company direction and culture. In total Gendius is made up of 15 talented individuals, this design project involved and united the whole team, the outcome created momentum and motivation for 2022’s workstream.
Inclusivity and accessibility are a core part of our work at Gendius and were embedded throughout the brand update. You can read more about the specifics of the design here – Gendius brand upgrade
Our new Gendius website was launched this year to provide a space for us to showcase our products, team members and exciting updates.
The CKD Screening Prioritizer (CSP)
Our state-of-the-art CKD Screening Prioritizer (CSP) will enable healthcare professionals to identify patients with type 2 diabetes that are likely to be experiencing abnormal kidney function. Predicting an individual’s risk of developing chronic kidney disease (CKD) means they can be prioritized for the life-extending treatment they require sooner.
The data science, design and development teams created the product with flexible implementation methods for different healthcare system needs.
Our lead data scientist commented on the project:
“Our pragmatic and creative approaches have led us to something that I believe could be a game-changer for patients and healthcare systems, and I cannot wait to showcase its real-world impact.”
Dr Camilla Sammut-Powell
Team Growth in 2022
In 2022 we hired four additional team members to support the delivery of our world class projects.
Ali Borazjani joins the team as Head of Quality Assurance and Regulatory Affairs. His background is in Medical Engineering, At Gendius he is using his expertise to implement a fully compliant QMS and obtain regulatory clearance to market the CSP and intellin Platform globally. With his support, we passed the ISO 27001 surveillance audit this year and have Stage one scheduled for February 2023.
Claudia Federico combines creativity, empathy and analytical skill to optimise user experiences. She is passionate about inclusive design, an advocate for digital accessibility and has extensive knowledge of Design Systems, design regulations and agile processes. As Lead Product Designer, Claudia has transformed the Gendius brand and communications. She has worked with our data scientists and developers to create the CSP product brand and user interface. She is also working across all our other product projects and providing investor communication content.
Hannah Lacey is a full stack developer with a background in visual art, passionate about problem solving, creativity and community. Experienced in web and mobile development and focused on producing clean, high quality code and design, she has already proved an asset to the development team working on all projects across both the intellin and Gendius brands.
Emily McBride is a marketing professional with a background in Media Psychology. Interested in diversity, inclusion and communication, she has taken over as the Social Media and Content Marketing Executive. In her time with us, Gendius has grown its overall audience on social media by over 56% and seen an increase in engagement of over 15%.
Our Contributions to the Scientific Community
We are dedicated to creating movement and innovation in patient care, sharing our work with the scientific and healthcare communities is our way of ensuring we are maximising our impact.
This year Gendius has published a study in the Future Healthcare Journal (FHJ) which details our development of the minimal resource pre-screening tool for chronic kidney disease in people with type 2 diabetes.
We published our conference abstracts for the European Association for the Study of Diabetes (EASD) annual meeting in September and the American Society of Nephrology (ASN) Kidney week in November. At both EASD and ASN, our data science team gave presentations going into the details on the global validation of our model.
In the later part of 2022 we published a feasibility study based on our work within the intellin platform. This publication focused specifically on the patient population with diabetic foot ulceration and highlights the benefits of active self-monitoring and pro-active care.
Link to the full study publication
We begin this new year inspired by the incredible work delivered in 2022.
2023 will be our year of impact and expansion.
– we can’t wait to keep you updated!
Gendius presents at American Society of Nephrology Conference
Diabetes technology innovator Gendius has presented research on its new data-driven tool to identify type-2 diabetes patients at higher risk of having reduced kidney function at the American Society of Nephrology (ASN) conference.
Gendius has developed its tool to help identify patients with Chronic Kidney Disease (CKD) earlier, by enabling healthcare systems to target CKD screening to those at highest risk.
Gendius’ data science model, which powers the predictive tool, was applied to AstraZeneca’s observational iCaReMe registry data covering 21 countries in 6 regions globally from 2018. The results of this validation show that the tool remained effective across global regions; by using the tool to risk-stratify patients, they were able to reduce the population by 43.1% whilst still detecting over 80% of those with reduced kidney function.
By identifying this subgroup of patients, healthcare professionals can prioritise patients appropriately for screening. The American Diabetes Association (ADA) and the National Institute for Health and Care Excellence (NICE) guidelines for diabetes patients recommend CKD screening every 12 months. However, annual screening is not always possible. In healthcare systems where large groups of patients have not been screened over 12 months, Gendius’ tool could be used to target those patients at greatest need.
This is increasingly important as healthcare systems across the world are experiencing increased pressure on services, exacerbated by COVID-19, and have large screening and treatment backlogs. Conducting prioritised screening in these settings and where resources are limited may be necessary to avoid unmanaged kidney function decline.
Susana Goncalves, CVRM Medical Director, AstraZeneca International, said, “We are very happy to have been able to establish the innovation partnership with Gendius to work towards increasing early diagnosis for CKD, one of our key priority areas. The findings suggest that Gendius’ cutting-edge, affordable and sustainable technology could enable a far more targeted and cost efficient approach to screening people with diabetes for CKD.”
Gendius CEO, Rory Cameron, commented, “It is exciting to be able to share these promising results at a US conference for the first time. Our hope is that our models could be used to better target chronic kidney disease screening within people living with type-2 diabetes, especially in the US, where healthcare costs are so high, screening resources need to be carefully managed particularly for those on Medicare and Medicaid. Gendius is really leading the way in a personalised risk prediction approach to managing diabetes, and we see this as the future of chronic disease management.”
Diabetes is the leading cause of kidney failure across the world, and in the US approximately one in three adults with diabetes have CKD. Early diagnosis and identifying risk factors is key for controlling CKD: if the condition is recognised early, its progression can be effectively slowed down[1]. New treatments for patients with CKD are now widely available, including Sodium-glucose cotransporter-2 (SGLT2) inhibitors, which have been shown to effectively slow the progression of CKD, and lower the risk of kidney failure and death in people with kidney disease and type 2 diabetes[2].
The full abstract can be accessed on the ASN conference website here.
[1] https://www.diabetes.org.uk/professionals/resources/shared-practice/kidney-care
[2] https://www.kidney.org/atoz/content/sglt2-inhibitors#:~:text=SGLT2%20inhibitors%20are%20effective%20at,who%20do%20not%20have%20diabetes.
Research shows Gendius’ models can identify high risk patients
Newly published research shows that Gendius’ models can identify which people with diabetes are at high risk of renal impairment
Research published in the Future of Healthcare Journal shows that models developed by UK healthtech startup Gendius can determine which patients with type 2 diabetes are at a high risk of renal impairment, allowing healthcare systems to prioritise the highest risk patients. The results of the study show that it is possible to reduce Chronic Kidney Disease screening by 46.3%, whilst still detecting over 80% of those with abnormal kidney function using Gendius’ models.
People with type 2 diabetes are at a higher risk of developing Chronic Kidney Disease (CKD), and it is recommended that they undergo annual screening. Gendius’ predictive models could help to highlight those patients at the highest risk of having an abnormal CKD screening result, so that they can be prioritised for screening. This is particularly important in healthcare systems where screening resources are limited, especially with rapidly rising numbers of patients diagnosed with type 2 diabetes worldwide.
Dr Camilla Sammut-Powell, Senior Data Scientist at Gendius, said, “We worked closely with clinical experts to determine the model inputs and considered what might be available to a clinician when applying the model. We developed two versions of the model for each marker of kidney function: a minimum-resource model containing only information available at a face-to-face encounter and a second version, encompassing additional information from laboratory test results available from the health record.
“For one of the markers, the minimum-resource model showed a 86.3% improvement, meaning that we could reduce the testing population by 46.3% whilst still detecting over 80% of those with abnormal kidney function. This is extremely promising for lower-to-middle income countries where laboratory test information may be lacking.”
Diabetes is the leading cause of kidney failure both in the UK and across the world and is responsible for about a third of people needing dialysis or a pre-emptive kidney transplant[1]. Early diagnosis and identifying risk factors is key; if CKD is recognised early, its progression can be effectively slowed down[2]. However, CKD is usually asymptomatic until it has progressed, making early intervention difficult without regular screening.
Rory Cameron, Gendius CEO, commented, “Our models can be used in two ways as part of a screening programme: where resources are limited, it can be used to reduce the screening population; or, if there is enough resource to screen everyone, it can be used to make sure those at a higher risk are screened first. Prioritising patients could result in earlier identification of CKD, enabling clinicians to intervene early to preserve kidney function.”
Gendius will be presenting further details on its chronic kidney disease pre-screening models at the European Association for the Study of Diabetes (EASD) conference in September 2022.
[1] https://www.kidneycareuk.org/about-kidney-health/conditions/diabetes/
[2] https://www.diabetes.org.uk/professionals/resources/shared-practice/kidney-care
Gendius presents at European Association for the Study of Diabetes (EASD) conference
Gendius presents validation of Chronic Kidney Disease pre-screening models at European Association for the Study of Diabetes (EASD) conference
UK diabetes technology start-up Gendius has presented the latest research on its pre-screening models for Chronic Kidney Disease (CKD) risk at the European Association for the Study of Diabetes (EASD) conference in Stockholm. The research focuses on Gendius’ validation of models Gendius has developed to predict which people with type 2 diabetes are likely to be experiencing abnormal kidney function.
Diabetes is the leading cause of kidney failure both in the UK and across the world, and is responsible for about a third of people needing dialysis or a pre-emptive kidney transplant[1]. Early diagnosis and identifying risk factors is key; if CKD is recognised early, its progression can be effectively slowed down[2]. Regular screening is recommended within diabetic populations to identify and manage undiagnosed CKD, but many patients do not attend the recommended number of screenings or regular testing may not be accessible.
Gendius has already combined UK general practice data with clinical and statistical expertise to predict which people with type 2 diabetes are likely to be experiencing abnormal kidney function[3]. The models have also been validated in a 3-year observational DISCOVER data study (covering 37 countries in 6 regions globally) and the AstraZeneca TakeCaReofMe programme data (5 countries). The models were shown to be applicable and relevant within global populations, demonstrating that it is possible to provide targeted screening when resources or care access are limited, as observed during the pandemic.
Gendius CEO, Rory Cameron, commented, “It is exciting to be able to share these promising results at a leading European diabetes conference. Our hope is that our models could be used to better target chronic kidney disease screening within people living with type-2 diabetes, especially in low- and middle-income countries where screening resources are more limited. Gendius is really leading the way in a personalised risk prediction approach to managing diabetes, and we see this as the future of chronic disease management.”
Susana Goncalves, CVRM Medical Director, AstraZeneca International, said, “We are very happy to have been able to establish the innovation partnership with Gendius to work towards increasing early diagnosis for Chronic Kidney Disease (CKD), one of our key priority areas. The findings presented at the EASD conference suggest that Gendius’ cutting-edge affordable and sustainable technology could enable a far more targeted and cost efficient approach to screening people with diabetes for CKD.”
She continued., “Validating the algorithm through AstraZeneca’s global DISCOVER registry, which was created to collect real-world clinical data on T2D patient characteristics, disease management, healthcare utilisation, quality of care and outcomes, gives this algorithm an incredibly strong evidence base, and we look forward to being part of its future development.”
Gendius will be presenting further details on its chronic kidney disease pre-screening models at the American Society of Nephrology’s (ASN) Kidney Week conference in November 2022.
[1] https://www.kidneycareuk.org/about-kidney-health/conditions/diabetes/
[2] https://www.diabetes.org.uk/professionals/resources/shared-practice/kidney-care
[3] https://www.rcpjournals.org/content/futurehosp/early/2022/08/25/fhj.2022-0020
Gendius technology for diabetes risk prediction launched in the GCC
Gendius technology for diabetes risk prediction launched in the GCC through new AstraZeneca patient support app, Health Gate
A new digital health platform which provides enhanced support to diabetes patients in the Gulf Cooperation Council (GCC) region has launched through a collaboration between British health technology startup, Gendius, and leading biopharmaceutical company, AstraZeneca.
The Health Gate patient support app is powered by Gendius’ unique, AI-powered Intellin® platform, which analyses patients’ clinical and lifestyle data to forecast their risk of developing diabetes complications, allowing users to track and manage their diabetes on a daily basis. Intellin is the only technology platform that calculates individual risk for developing diabetes complications, and provides clinically-validated guidance on how they can best manage that risk.
In addition to the integrated risk monitoring through Intellin, Health Gate also offers patients a comprehensive diabetes management solution through access to online consultations, e-prescriptions, access to a library of additional resources, and educational materials.
Gendius’ CEO, Rory Cameron, commented, “We are so pleased to have been able to work with the AstraZeneca team to bring this exciting new technology platform to diabetes patients in the GCC countries. Our Intellin AI-driven risk monitoring, in combination with the enhanced patient support and HCP engagement, makes this a really comprehensive remote management solution. We look forward to further close collaboration with the AstraZeneca team in the future to further enhance and expand the platform.”
Enhanced diabetes management is high on the agenda of the GCC countries, Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. Increased awareness and education about the best ways to manage diabetes and reduce the risk of developing serious complications have been identified as key to addressing the impact of diabetes in the region.
The partnership between Gendius and AstraZeneca was implemented within the framework of AstraZeneca’s Emerging Markets Health Innovation Hubs initiative to create integrated science ecosystems through local bio-hubs across the world. AstraZeneca’s Health Innovation Hubs have fast become vital resources for Emerging Market countries, bridging the gaps in infrastructure while promoting shared working across the International region.
Gendius initiates GP Data Study
Gendius initiates GP data study to develop enhanced risk prediction tools for diabetes
UK medtech start-up Gendius has partnered with over 60 primary care practices on a data extraction study to develop enhanced risk prediction tools for people with diabetes. The study will analyse real-world data from thousands of people with diabetes in order to validate and improve more sophisticated risk prediction algorithms for predicting an individual’s risk of developing diabetes complications.
Dr Natasha H Patel, Consultant Diabetologist at Guys and St Thomas’ NHS Foundation, comments, “This is a really exciting project which could really benefit people with diabetes, as well as their clinicians. In my clinic, we see patients who have the worst array of diabetes complications, and my hope is that one day our risk prediction and management tools will be good enough that we’ve identified these patients earlier enough to intervene and prevent them from developing these complications. This project from Gendius is an exciting step towards that future.”
Once validated, the new algorithms will be used to power Gendius’ diabetes management platform, Intellin. The key areas of risk prediction Gendius is aiming to improve are Chronic Kidney Disease and Cardiovascular Disease, both potentially fatal complications from diabetes.
Diabetes is the leading cause of kidney failure in the UK, and is responsible for about a third of people needing dialysis or a pre-emptive kidney transplant[1]. Early diagnosis and identifying risk factors is key, as if Chronic Kidney Disease is recognised early, its progression can be effectively slowed down[2].
Similarly, people with diabetes are at higher risk of developing Cardiovascular Disease. Even marginally raised blood sugar levels, as well as high blood pressure and cholesterol, can seriously affect cardiovascular health in people with diabetes, so good diabetes management is essential[3].
Gendius CEO, Rory Cameron comments, “There is a clear need for a more personalised approach to highlighting diabetes risk factors. With this latest step forward with our risk prediction models, we hope that our platform will be able to give people with diabetes the power to better understand their individual risk, and allow them to take steps to reduce that risk.”
Gendius is aiming to recruit 100 primary care practices to the study, but has already hit its minimum sample size of 9,000 patient records. All the patient data shared for this study is fully anonymised and patients will have given their consent via their GP practice for their data to be shared.
[1] https://www.kidneycareuk.org/about-kidney-health/conditions/diabetes/
[2] https://www.diabetes.org.uk/professionals/resources/shared-practice/kidney-care
[3] https://www.diabetes.org.uk/guide-to-diabetes/complications/cardiovascular_disease
Gendius selected for Tech Nation’s Applied AI growth programme
Manchester-based healthtech innovator, Gendius, has been selected for Tech Nation’s Applied AI growth programme.
Gendius uses its sophisticated AI platform to power digital health solutions for preventing and managing chronic diseases. The award-winning Intellin® app platform, which allows individuals and their healthcare teams to manage their diabetes more effectively, is the first application of Gendius’ AI platform.
Gendius’ key innovation that its platform uses algorithms developed from 10-year longitudinal datasets. These algorithms enable the Gendius platform to identify an individual’s risk for developing complications, allowing for earlier healthcare and lifestyle interventions.
Sam Beni, Applied AI programme lead, said: “We at Tech Nation are delighted to welcome such a wide range of innovative companies to our third Applied AI cohort, and to support them on their scaling journeys.
“Following the turbulence of 2020 with the global pandemic, the number of Applied AI scaleups focussing on transforming the world of healthcare is a beacon of hope for the coming years, and the breadth of industries that these AI scaleups are disrupting is testament to AI’s power to shape the world we live in.”
To date, Gendius’ Intellin® mobile app has been downloaded over 600,000 times and it has over 50,000 monthly active users. The user app allows people with diabetes to plan ahead by forecasting their risk factors for developing complications, such as chronic kidney disease or diabetic foot ulcer. The user app also works with a web-based dashboard for healthcare professionals, which allows them remotely monitor their patients’ disease management.
Applied AI is Tech Nation’s first growth programme for Artificial Intelligence to help the UK’s most promising founders who are applying AI in practical areas and creating real-world impact. The cohort for Applied AI 3.0 includes a wide range of tech companies, including areas outside health tech such as data analytics, agritech, foodtech, lawtech, retail tech, energy, proptech, fintech, and femtech.
Gendius to collaborate with The University of Manchester on New Human-AI Research Teams.
Gendius are proud to be a part of the new Human-AI research teams developed by the University of Manchester to help cure humanity’s complex future health and societal problems through AI technology.
Gendius are proud to be a part of the new Human-AI research teams developed by the University of Manchester to help cure humanity’s complex future health and societal problems through AI technology.
Led by Professor Samuel Kaski from The University of Manchester, this research fellowship will maximise the untapped potential for research in AI and complex decision making and will aim to develop new ways for machine learning (AI) to help humans during the process of designing experiments and interpretation of the results, before deciding what to measure next and to finally reach trustworthy solutions to problems.
This includes healthcare, where AI can detect patterns associated with diseases and health conditions by studying healthcare records and other data.
Professor Kaski said: “This is where AI can help, but we need new kinds of AI assistants which can learn to work well with humans and complement their skills. That requires new fundamental AI research, and I am glad Manchester has recognized this opportunity and is considerably strengthening its AI research. Manchester is a top-notch place to build and apply new AI which matters and has impact.”
This new approach will be applied to three challenges: diagnosis and treatment decision-making in personalised medicine; the guidance of scientific experiments in synthetic biology and drug design; and the design and use of digital twins to design physical systems and processes.
Rory Cameron CEO Gendius said: “We are very privileged to be in the list of collaborators that include some big names in AI and Science. The next phase for our algorithm development moves us into the Artificial Intelligence space and this collaboration will be instrumental to this”.
Named after AI pioneer Alan Turing, the Turing AI World-Leading Researcher Fellows are part of the UK’s commitment to further strengthen its position as a global leader in the field and is collaborating with 39 industry partners. Gendius are very proud to be a part of this collaboration which also includes AstraZeneca, IBM, Dyson, Google Deepmind UK, BBC, British Library, Huawei and Amazon Research Cambridge.
Gendius partners with the University of Nottingham to develop AI risk prediction technology
The project was awarded £250,000 of funding from Innovate UK.
Digital health innovator, Gendius, has partnered with experts at the University of Nottingham’s Digital Research Service to develop highly accurate risk prediction technology for diabetes complications, such as chronic kidney disease (CKD) and cardiovascular disease (CVD). The artificial intelligence algorithms developed through the partnership will be used to optimise Gendius’ world-leading diabetes risk management platform, Intellin®.
The project, which officially started in July 2021, is being led by Dr Philip Quinlan and Dr Grazziela Figueredo from the Digital Research Service at the University, and was made possible thanks to £250k of funding from Innovate UK.
Dr Grazziela Figueredo comments, “This is an exciting opportunity to work with an interdisciplinary team to research and develop responsible AI tools that will help GPs promote better care for diabetes patients. This project will help clinicians and patients to better understand diabetes-associated disease progression and how individual behavioural changes might impact it.”
Manchester-based Gendius is one of the UK’s leading MedTech startups, and has developed advanced diabetes management solutions powered by its proprietary AI-driven technology. Gendius uses a clinically validated logic engine, its Intellin® platform, to actively monitor patients’ diabetes management.
Intellin® uses individual clinical histories to highlight users’ risk of developing diabetes-related complications, not only enabling people with diabetes to take more control over their condition, but also allowing clinicians to provide more targeted advice and management strategies.
Rory Cameron, Chief Executive Officer and Co-founder of Gendius, says, “We have been working with the team at the University of Nottingham for several years and this award enables us to move forward in our algorithm development. The team have a unique blend of data science, behaviour change and developer expertise that will make a considerable impact to our Intellin® platform.
He continues, “Diabetes is the leading cause of kidney failure, lower limb amputation, blindness and considerably increases your risk of a cardiovascular event and this partnership will help us in our journey to understand and prevent the complications of chronic diseases such as diabetes.”
Identifying and treating diabetes complications early has been highlighted as a key way of improving outcomes for people with diabetes. Diabetes is the most common cause of end-stage kidney failure in the UK, and it doubles the risk of cardiovascular disease, including heart attack, heart failure, angina, and stroke. It is estimated that treatment of diabetes and diabetes complications accounts for 9% of the total NHS budget, and that 10% of NHS hospital beds are occupied by people with diabetes.
