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Idea Description
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Innovation 'Elevator Pitch':

Heart DNA is a genetic testing kit for patients at increased risk of developing atrial fibrillation and other cardiovascular diseases, the results are reviewed and assessed by a consultant who is well informed about the patient’s medical history.
Overview of Innovation:
“Heart DNA” is a genetic testing service for patients at increased risk of developing cardiovascular diseases and for cardiologists and genetic counseling officers/geneticists who would want to work with us in delivering this service to the public.

We are partnering with healthcare professionals who will review (online) the genotyping reports coming from our well established partner lab and will be giving their health assessment based on both: the patient’s health profile/medical record, which our users will be asked to fill in early on our website, and on the genetic predispositions that may be found in the patients DNA. In esssence, our consultants will be able to give an informed screening assessment that covers: the detection of inherited conditions and an assessment to the patients’ response to certain drugs that may well be administered to treat CVDs.

Heart DNA is a simple saliva-based test that is supported by scientifically validated research and an extensive amount of studies. Heart DNA analyses the patient’s unique genetic markers, which influence a broad range of heart-related conditions, our gene panel list consistc of 96 markers that cover: Atrial Fibrillation, Coronary Artery Disease, Myocardial Infraction, Cholesterol levels, and risks for hypertension. It can also help identify a patient’s propensity for increased risk towards certain heart medications, eight classes of drugs that affect the cardiovascular system are examined; anti-platelets, anti-coagulants, statins, stimulants, beta-blockers, ACE inhibitors, calcium channel blockers and hormone therapies.

Our test provides information that allows Doctors to;
1. Monitor a patient’s specific health conditions thoroughly.
2. Prescribe a more optimal medication and dosage for a patient.
3. Suggest early lifestyle and diet interventions to help combat and prevent certain heart conditions.

Overall, the aim is to enable doctors and patients to bridge the gap in genetic information that has proved over an extensive amount of studies and research to be pivotal in the design of better prevention and treatments regimens. Our focus is to cause a change in the architecture of complex care routines that would address the challenges of working at scale, and which can capitalize on the associated opportunities that we will enable by striking business partnerships with medical consultants to create and deliver a distinctive competitive advantage over all competing genetic testing companies.
Stage of Development:
Trial stage - Trial stage to prove that the idea actually works as intended
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Innovation 'Elevator Pitch':
Heart DNA is a genetic testing kit for patients at increased risk of developing atrial fibrillation and other cardiovascular diseases, the results are reviewed and assessed by a consultant who is well informed about the patient’s medical history.
Overview of Innovation:
“Heart DNA” is a genetic testing service for patients at increased risk of developing cardiovascular diseases and for cardiologists and genetic counseling officers/geneticists who would want to work with us in delivering this service to the public.

We are partnering with healthcare professionals who will review (online) the genotyping reports coming from our well established partner lab and will be giving their health assessment based on both: the patient’s health profile/medical record, which our users will be asked to fill in early on our website, and on the genetic predispositions that may be found in the patients DNA. In esssence, our consultants will be able to give an informed screening assessment that covers: the detection of inherited conditions and an assessment to the patients’ response to certain drugs that may well be administered to treat CVDs.

Heart DNA is a simple saliva-based test that is supported by scientifically validated research and an extensive amount of studies. Heart DNA analyses the patient’s unique genetic markers, which influence a broad range of heart-related conditions, our gene panel list consistc of 96 markers that cover: Atrial Fibrillation, Coronary Artery Disease, Myocardial Infraction, Cholesterol levels, and risks for hypertension. It can also help identify a patient’s propensity for increased risk towards certain heart medications, eight classes of drugs that affect the cardiovascular system are examined; anti-platelets, anti-coagulants, statins, stimulants, beta-blockers, ACE inhibitors, calcium channel blockers and hormone therapies.

Our test provides information that allows Doctors to;
1. Monitor a patient’s specific health conditions thoroughly.
2. Prescribe a more optimal medication and dosage for a patient.
3. Suggest early lifestyle and diet interventions to help combat and prevent certain heart conditions.

Overall, the aim is to enable doctors and patients to bridge the gap in genetic information that has proved over an extensive amount of studies and research to be pivotal in the design of better prevention and treatments regimens. Our focus is to cause a change in the architecture of complex care routines that would address the challenges of working at scale, and which can capitalize on the associated opportunities that we will enable by striking business partnerships with medical consultants to create and deliver a distinctive competitive advantage over all competing genetic testing companies. 
Stage of Development:
Trial stage - Trial stage to prove that the idea actually works as intended
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Digital health / Patient and medicines safety / Person centred care
Benefit to NHS:
DNA testing is not available at the point of care, regardless of its imperative potential to mitigate treatment regimens and enhance disease prevention pathways. Moreover, once an individual is diagnosed as having a cardiovascular condition, the challenge exist in prescribing the right medication at the right dose in the right time.
Tools promoting optimal direction for healthcare service and moving patients towards the digital space will be hugely disruptive in a market where faster processes and cheaper costs are imperative to its evolution. Products that can enhance the working process inside GPs offices and provide more rapid, reliable and robust diagnosis decisions within primary care, that could enhance workflow for healthcare professionals, assisting earlier triage and potentially redesigning GP care pathways; such products have the potential to save the healthcare and biotech industries over £1bn every year, just in labour time. 

The current pathway to obtain a genetic test for a single cardiac condition through the NHS is lengthy, complex, costy and is not accessible for everyone; with multiple visits and referrals to see healthcare specialsits (Annex; Figure 1). 
Our system workflow has been designed to empower patients within an innovative framework, that ensures having a certified partner cardiologist assessing their health condition before a patient can receive his/her genotyping results. It will also ensure that patients and doctors have an easy access for booking appointments to follow up, when the need is present. Our comprehensive service will cut down the turn around time from several months to 2 weeks with as little steps as the figure shows (Annex; Figure 2). 

Moreover, our database will later provide an electronic medical record through which other healthcare consultants can opt to review when they need to access the patient’s genotype before prescribing a certain drug at any stage of the patient’s life. Thus, cutting down the path of trial and error before the the right medication is prescribed to the patient. 

Early screening for genetic predispositions and having an early risk assessment for patients who may develop Arterial Fibrillation or any other CVD will significantly allow the NHS mitigate prevention regimen for the general public before they become patients. Thus, signinficantly reducing the £15bn bill of CVDs every year (BHF stats 2015).

 
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
The major risk factor associated with Atrial Fibrillation and all other CVDs is having a family history with the disease. By family history we are referring to the genes that have passed from the parents to their offspring, which (if found to be mutated as well) can increase the risks of that individual developing the same disease. 
While it is well accepted that such risk factor could not be changed or adjusted (at least for the time being), hence the term "non-modifiable" risk factor, it is also accepted that if such risk is detected then the patient would be better positioned to manage the other "modifiable" risk factors early on, which can significantly change the course of the patient's life and the development course of his/her inherited condition. 

We believe that well informed and educated individuals about their risk factors will allow them take better decisions and have more enlightened judgments when it comes to managing their risk factors and altering their lifestyle and daily habits. Modifiable factor like quite smoking, being fit, eating healthy and managing diabetes, obesity and cholesterol levels, are all found to be imperative in managing AF and other CVDs from an early stage, the earlier the intervention, the better the outcome. 

Moreover, we believe the greatest benefit to the WM population will come at a later stage through our Data Bank which will provide the perfect reference tool to better direct prevention and treatment regimens withihn the WM population, risk factors such as race, age and sex will all be considered in the future direction towards an advanced and precise person-centerd system.



 
Current and planned activity: 
Business partnerships have all been established for the development and delivery of our product/service. Funding is currenly sought to finance our outsourcing agreements:
  • Genotyping analysis will be conducted at a well established genotyping lab in the UK.
  • Our saliva collection kits will be outsourced from a supplier in the UK. 
  • Our service content is all in place and the gene panel list has been put together through an extensive amount of well researched and accredited reference genetic testing studies, the online platform will be developed by website developement agency in Birmingham.
  • Our box and packaging have been designed and the order is to be placed.
  • An initial agreement has been established with a reputable cardiologist consultant to review the patients results and put his recommendations to each genotyping report being assessed.
  • A pilot study is currently being designed by our Medical and Research Officers (both are GPs at the QE hospital). 


 
What is the intellectual property status of your innovation?:
The company will be developing additional patents and intellectual property related to response and side effect prediction for further treatments of hypertension and other Cardiovascular disorders through its DTC kits and the databank that it will generate from its lab based genotyping services. These will be offered to the BHF and all other concerned research groups in the field of Cardiac Health.

In terms of our regulatory path, there are no specific regulations outside consumer protection, data storage, and for storing biological samples “saliva” we will apply control regs that deal directly with this. 
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
Simple
Regional Scalability:
Please refer to our commercial information section (Business Strategy)
Measures:
​We are here to help; we believe that we have a relevant and compelling solution that (if adopted) can save lives and enhance the prevention and treatment regimens for patients with cardiovascular conditions.
We will measure our performance based on the value that we are delivering. Hence, by the end of year one we are looking to exceed the 1000 kits sale and have a strong clinical data that would support our proposition, in regards to giving patients better options to mitigate their risk factors and to healthcare professionals to administer drugs that are better suited for certain subpopulations; based on genetic makeup and the health profile "environmental factors" for each individual patient.
These assessments will be made through our end of year statistical study that we will run on all the patients whom we have tested. 
Adoption target:
The adoption target is to demonstrate a successful, valuable and cost efficient systematic framework that would address the core objectives of the NHS Sustainability and Transformation Plans in drving a genuine chnage to patients experience and health outcomes of the longer term.
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Innovation 'Elevator Pitch':
A medical screening technology based on a mathematical model of the autonomic nervous system & physiological systems which has significant potential to improve the cost-effectiveness of primary care
Overview of Innovation:
Strannik technology is based upon a mathematical model of the autonomic nervous system and physiological systems. It meets the key aims and objectives of the EC’s Human Brain Project: (i) to identify what the brain does and how it does it, (ii) to develop a new generation of cognitively-based screening technology, (iii) to understand and adapt with therapeutic effect the multi-level nature of brain function.  This is quite without precedent in modern medicine. The Strannik technology comprises Strannik Virtual Scanning (SVS) and Strannik Light Therapy (SLT). 
The technique can be viewed in a demonstration video at the following link: www.montaguehealthcare.co.uk/presentation.php
SVS is a screening technology which has an unprecedented ability to determine the health of the patient i.e. it is able to determine 5-15 pathologies in each of the 30 main organs (including medical conditions for which the current tests are poor or for which there is currently an unmet clinical need), to differentiate between and quantify the extent of the genotype and phenotype in each pathology, and to determine the earliest onset of each pathology from its presymptomatic origins. The technique adopts a methodology more advanced than is currently used in most diagnostic technologies. It is non-invasive and more safe than contemporary diagnostic tests. The results are available in circa 20 minutes at a cost which is estimated to be 5-10 times lower than contemporary diagnostic tests. It presents the opportunity to screen the entire UK population once (or twice) each year for less than £5BN (est £3-4BN) and to reduce the cost of healthcare by an estimated £20BN pa.
(See Operating Manual: www.montaguehealthcare.co.uk/OperatingManual.pdf)
The basic methodology, and the scope of this technology, is outlined in a series of 60 peer-reviewed medical papers.
(uk.linkedin.com/pub/graham-ewing/44/386/214)
 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Clinical trials and evidence / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
Strannik Virtual Scanning is able to determine all common pathologies in a single test of 20 minutes duration. In-market surveillance has indicated that SVS appears to be circa 2-23% more precise than contemporary methods of diagnosis. A recent non-clinical study in Spain (10/16) illustrated that the technology was able to determine all known medical conditions in the cohort of (20) patients.
 
Using the data derived from this cognitive, computer-based, test the technique determines the precise parameters of Strannik Light Therapy -which acts upon autonomic dysfunction, and (across a wide range of medical indications) appears to be typically 83-96% effective. This compares with the 50% effectiveness of drugs and also that the effectiveness of many drugs declines over a period.
 
Benefits:
 
  • reduce the flow of patients into the healthcare system;
  • reduce the cost and complexity of training the GP
  • improve the ability of the GP to identify complex medical conditions, reduce the need for repeat consultations, and/or avoid doctor errors
  • reduce the need for histopathology samples (nurses, rubber gloves, sampling tubes, transport costs, histopathology lab costs)
  • reduce expenditure in secondary care i.e. for highly expensive scans and tests;
  • provide health reports and increase the ability for patients to have a clear understanding of their health and assume responsibility for their health i.e. change the focus of medicine  from treating the symptoms to prevention
  • regularly screen the health of the most at-risk patients thereby reducing the need for A&E services
  • improve the accuracy of drug prescribing thereby avoiding mis-prescribing of drugs
  • reduce the need for drugs
  • reduce the overall cost of healthcare by an estimated £20BN pa
“I have to hand it to you. You have correctly and in precise detail identified the five or six major items which are known to be of concern to me”. Dr John Doran, Medical Director, Nottingham’s Queens Medical Center, November 2003.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Support patients to obtain an early diagnosis to seek timely treatment.
Current and planned activity: 
Mimix Montague Healthcare is actively seeking NHS partnerships to move forward Strannik Technology. Evaluation and trials have been conducted in other countries (Russia and Spain) and a collaboration within the UK is currently being sought.
 
  • Procurement / Adoption of Strannick Technology within NHS Trusts
  • Evaluation / Validation / Clinical Trial - Need to gain additional validation seeking a trial centre.
  • Project Assistance required - The Company’s development project is interested in locating possible clinical / academic collaborators.
What is the intellectual property status of your innovation?:
software/copyright
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
3 years +
Ease of scalability: 
Simple
Regional Scalability:
The technology is immediately scaleable. In theory, and as an indication of scaleability, we could train 1000 practitioners to use Strannik technology within 4 weeks. 
Measures:
Strannik Virtual Scanning is unique for a number of very good reasons e.g. (i) that it can determine pathological onset from its presymptomatic origins, (ii) it can determine the full spectrum of pathologies in all organs and not just a single biomarker, (iii) it can determine genotype and phenotype, and (iv) it can determine many conditions where there is currently an unmet clinical need.  Further studies are required to illustrate how such a sophisticated technology will complement the current range of biomarker tests which are generally used in clinical practice. The technique is non-invasive and has a base cost of circa £15/test thereby addressing safety and cost.  The procedure is entirely non-invasive which significantly enhances the patient experience, often experienced as 'a pleasure'.  
Strannik Light Therapy is based upon an understanding of how the brain regulates the autonomic nervous system.  A comparison of Strannik Light Therapy with contemporary methods of treating patients is likely to enhance the patient experience, result in significantly reduced side-effects, and will be at very much lower cost.
Success will be measured by reduced number of patient consultations, lower cost of diagnosing and treating patients. 
Adoption target:
Our aim is to secure the introduction of Strannik technology to every primary care practice
Rejection Reason:
Dear Mr Ewing Thank you very much for your submission to the Meridian Innovation Health Exchange. I can confirm that we have now reviewed your submission and i regret to inform you that we have not been able to identify any clinical champions for this project. While I appreciate that Strannick are looking for support on the evaluation/evidence side, feedback from clinical / academic colleagues has not been positive and therefore we have done everything possible to engage but the appetite isn't there unfortunately. Given that our network is not focussed in exploring this area at this time we will therefore close your idea leaving it visible to our Meridian users. We wish you luck with your innovation. Regards The Meridian Team
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Innovation 'Elevator Pitch':
Dip.io, a CE approved product turns the smartphone into a clinical grade device enabling lay-users to test urine in their own home, with clinical accuracy and share results electronically with their clinician. 
Overview of Innovation:
42m urine tests a year are undertaken in the NHS to screen for a wide range of conditions. Currently patients collect a sample at home and bring it to the clinic or provide a sample in the clinic where it is either tested on site or sent to a laboratory. This is inefficient, inconvenient for the patient and presents opportunity for improvement in patient experience, clinical quality and cost efficiency.
 
Healthy.io is the first company to turn the smartphone into a regulatory-approved clinical device. Its first product, Dip.io, uses computer vision and user centric design to turn the smartphone into a urinalysis device. Built around existing semi-quantitative urinalysis dipsticks, Dip.io complements established clinical efforts by empowering patients to test themselves at home with no quality compromise, and securely share results with a clinician.
 
Healthy.io is empowering patients to take urine testing into their own hands, opening up an immense opportunity to improve preventive efforts and enable early interventions. Key pathways in which digital urinalysis has strong potential to improve patients’ lives and reduce cost to the NHS:
  • Antenatal care: women with hypertension or diabetes in pregnancy have a higher risk of developing pre-eclampsia, a leading cause of maternity morbidity. Dip.io has proven through a usability study at Johns Hopkins to improve women’s experience and could reduce outpatient appointments amongst high risk pregnant women. 
  • Chronic Kidney Disease (CKD): Home-based screening of albumin:creatinine (ACR) for people with diabetes or high blood pressure, to increase adherence to NICE CG 182 and diabetes care process beyond the current level of 50%.
  • Urinary tract infections (UTI): opportunity to improve self-management for patients at risk of admission from UTI (e.g. MS), reduce the 5m GP attendances for UTI in primary care and create digital pathways for pre-op assessment  through using digital urine testing, within existing clinical guidelines.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
Benefits to NHS in line with FYFV:
  • Maternity Safety (Proteinuria screening): The Maternity Transformation Programme (Better Births) prioritises improvement in maternity safety and provision of consistent quality. This includes halving the rates of stillbirths, neonatal and maternal deaths by 2025. Around 15% of women with hypertension or diabetes in pregnancy have a higher risk of developing pre-eclampsia, a leading cause of maternity morbidity. Automated home-screening for proteinuria in at-risk pregnancies has the potential to early identify pre-eclampsia, save £1,500 for each avoided false negative, save up to £75m by reducing 60% of outpatient appointments (3rd trimester) and reduce antenatal consultation time by 25%.
 
  • Primary Care (Diabetes and CKD screening): Smartphone enabled self-testing offers a critical complement to existing population health efforts by shifting testing from primary care to the home. Providing alternatives to face-to-face contact frees up GP resources and nursing time. NICE recommends that every person at increased risk of CKD (people with diabetes or hypertension) needs to annually get their urine tested. However only 50% of people with diabetes and 30% of people with hypertension have a regular urine test reported. Over 1 million cases of CKD remain undetected. Diffusing Dip.io to every at risk patient (8.3m) could improve adherence with no additional overhead, reducing CKD cost by up to £1bn.
  • Urgent and Emergency Care (Urinary Tract Infection): Conducting common diagnostic tests at the patient's home supports "improving the ability of patients to self-care for minor illnesses" (UECR).  This includes the need to anticipate recurring conditions such as UTIs. 1-3% of GP visits are UTI related and UTIs accounted for 14% of emergency hospital admissions in MS patients costing the NHS over £43 million. Dip.io offers the opportunity to improve self-management for patients at risk of admission from UTI, reduce the 5m GP attendances for UTI in primary care and create digital pathways for preop assessment within existing clinical guidelines.
 
  • Harnessing technology and innovation: Our solution leverages existing technology to transform care delivery and supports the drive to digital adoption. We easily integrate into other technologies (integrated with PKB and Allscripts) and make sure interoperability is built in. We are replicating this model for our next product to bring innovation to woundcare management.
Initial Review Rating
4.60 (1 ratings)
Benefit to WM population:
Our smartphone-enabled digital urinalysis service aims to improve quality and efficiency of existing pathways, driving better patient outcomes and experience.
 
Main benefits:
 
Maternity safety: women with hypertension or diabetes in pregnancy have a higher risk of developing pre-eclampsia, a leading cause of maternity morbidity. NICE CG62 recommends dipstick urinalysis during each prenatal visit to screen for proteinuria, an indicator of pre-eclampsia. Increasing testing in between regular pre-natal visits could reduce Pre-eclampsia complications. Women with at-risk pregnancies receive 7-10 Dip.io kits. Following a defined frequency, the women conducts the test at home. The clinician automatically receives the results and is alerted if results are abnormal for immediate follow-up care. This model of care is being rolled out across mayor HMOs in Israel and received more than 90% preference in a Johns Hopkins usability study. Dip.io has proven to improve women’s experience and could reduce outpatient appointments amongst high risk pregnant women.
  • Diabetes and CKD screening: NICE clinical guidelines recommend people with diabetes/hypertension need to get their urine tested annually but adherence is low e.g.  only 51% of people with type 1 diabetes tested. Digital testing could improve adherence and reduce costs. Patients with no recorded albumin reading receive our smartphone urinalysis home-test. Results are immediately available to the clinician and those with abnormal results are invited to a follow-up extensive checkup. This model makes it possible to reach people at risk, who have not received appropriate testing, thus increasing adherence to CKD screening.
  • Urinary Tract Infection (UTI): opportunity to improve self-management for patients at risk of admission from UTI (e.g.MS), reduce the 5m GP attendances for UTI in primary care and create digital pathways for preop assessment   through using digital urine testing, within existing clinical guidelines.
Current and planned activity: 
NHS:
  • North East and North Cumbria AHSN with South Tees NHS Trust to test renal clinic at home funded by Northern Counties Kidney Foundation
  • NeuroResponse social enterprise based at UCL on Multiple Sclerosis pathway
  • Modality and Yorkshire and Humber AHSN to test diabetes/CKD screening model
  • Howbeck Healthcare to test rollout diabetes/hypertension/CKD screening model in South Cheshire and Vale Royal
  • Salford NHS Trust rollout for renal patient management
  • Care UK rollout for uncomplicated UTI management
  • Applied to the Test beds, have been invited to the follow-up meeting for at risk pregnancy, UTI and renal models
 
International:
  • Usability study in pregnant women at Johns Hopkins with 92% favourability (soon to be published)
  • US National Kidney Federation and Geisinger Health to improve care for people with hypertension
  • Dutch Kidney Foundation and Dutch Health to test population screening for ACR in at risk population compared to other method
  • Rolling out in two HMOs in Israel for at-risk pregnancy model
Return on Investment (£ Value): 
N/A
Return on Investment (Timescale): 
N/A
Ease of scalability: 
Simple
Regional Scalability:
Our plan is to scale regionally and nationally through a B2B2C business model. We offer several commercial packages that differ in terms of scale, level of integration, agreement timeline and distribution/shipment method.  This allows us to partner with different players within the NHS to provide them full digital capabilities through customised, white label kits, a localised application and access to our algorithm in an end-to-end service proposition. Our vision is to serve as the backbone for smartphone enabled, image based medical diagnostics and enable partners to bring our innovation to their existing user base.
Measures:
Healthy.io and the Dip.io solution work together with healthcare organizations to improve efficiency, value and outcomes by digitizing existing pathways. Measure include:
  • Save outpatient appointment and reduce consultation time to reduce resource pressures.
  • Increase clinical guideline adherence, improving patient safety
  • Improve patient experience (e.g. minimise absence from work and avoid travel expenses)
Adoption target:
Start with a phased roll out to try, test and scale the innovation in a regional NHS organisation. We anticipate that success from this roll out will lead to spreading the implementation of the technology to other specialties within the organisation, other hospitals/GPs within the group and to other providers and partners within the WM area.
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