Atrial Fibrillation - Detect - Protect - Perfect
We invite you to share any work you are doing in the areas of identifcation, protection, management and whole pathway re-design of AF to share and improve the outcomes for people at risk of having an AF related Stroke. 

Ideas (Long term conditions: a whole system, person-centred approach)

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: 
Regional Scalability:
Please refer to our commercial information section (Business Strategy)
​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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Abdullah Sabyah 26/11/2016 - 15:10 Sign Posted 12 comments

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