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MIT

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Disruptive blood screening solution to cut heart disease and diabetes costs up to 25% by enabling preventive medicine in routine healthcare.

Description

Summary

We foresee our technology to have the potential to bring global costs of heart disease and diabetes down up to 25% and lower the mortality up to 15% within the next 10 years. This would translate to more than 300B USD annual global savings and enhance the lives of millions suffering of heart disease and diabetes.

Heart disease is the biggest cause of death globally. It is routinely diagnosed with a cholesterol test to treat and medicate people. Yet, 50% of people hospitalized for a heart attack have normal cholesterol values. It is widely acknowledged that the cholesterol test provides insufficient biological information to predict systemic diseases such as heart disease and diabetes. To capture the complexity of these systemic diseases, more comprehensive biological data is needed.

We introduce a disruptive blood screening solution where we take the same blood sample drawn for a cholesterol test and run it with our technology. Instead of the standard 4 biomarkers of a cholesterol test, the technology provides 228 blood biomarkers from a single blood sample, while keeping the cost the same. The comprehensive biomarker data has been shown to significantly improve heart disease and diabetes risk prediction in more than 100 peer-reviewed articles published in the leading biomedical journals.

The blood screening technology, developed during a decade of academic research, is based on nuclear magnetic resonance (NMR) spectroscopy and our proprietary biomarker quantification software. The technology is designed for rapid clinical uptake, by including the same cholesterol and glucose measures that the doctors currently use and know how to interpret.

With this solution, we aim to replace routine cholesterol testing in primary healthcare. The technology provides 224 additional biomarkers at no added cost while enabling the new era of disease risk prediction: 3-fold more accurately than current clinical tools, for early heart disease and diabetes detection.

What are the key outcomes and impact of your solution?

Our blood screening technology would impact the lives of 1/3 of world’s population. It’s the single biggest healthcare problem, but it’s also something that can be fundamentally enhanced by reinventing the routine blood testing.

Heart disease and type 2 diabetes are primarily lifestyle-related diseases that develop over lifetime. Due to the ability to impact the disease progress at any stage in life, early detection and continuous prevention is a massively more efficient strategy to manage these metabolic diseases than treating acute events.

Our comprehensive blood screening technology provides 228 metabolic biomarkers as a part of routine primary care blood testing, providing clinicians and patients with unprecedented insight into a person’s future disease risk. Significantly better understanding of heart disease and diabetes risk enables early prevention for avoidance of acute events and associated costly treatment, yielding tremendous healthcare and financial impact.

We foresee the technology to have the potential to bring the global costs of heart disease and diabetes down up to 25% and lower the mortality up to 15% within the next 10 years. The relevant metrics are:

  1. Replacing routine cholesterol testing with 50x more biological data
  2. Achieving 3-fold more accurate risk prediction of heart disease and diabetes in routine healthcare
  3. Keeping the cost of advanced risk profiling comparable to routine cholesterol test to make an impact in primary healthcare in developed and developing countries
  4. Lowering heart disease and diabetes related mortality up to 15%
  5. Lowering heart disease and diabetes related costs up to 25%

What actions do you propose to realize your stated goals?

There are no silver bullets in healthcare. The main actions need to be long term and targeted towards the biggest impact potential. This means targeting primary care and specifically routine blood testing. When we can address routine blood testing with our technology, the impact potential in heart disease and diabetes prediction and prevention is unprecedented. Therefore, our key actions focus on routine blood testing.

We have started our work towards the clinical use of our technology through academic research, and the technology already holds a leading position among top universities and biobanks in the world. We will continue to cooperate with the scientific community, where we are in a unique position to perform biomarker analysis on the largest sample collections in the world, to further demonstrate the predictive and preventive power of our technology. We are also committed to conduct translational research, both internally and with our academic partners, to continuously uncover additional novel clinical applications for our analysis, primarily in the area of heart disease and diabetes.

This scientific foundation allows us to take our solution to clinical diagnostics during the next year. We have started to prepare our solution for clinical uptake already two years ago. During this time period we have:

  1. Completed the world’s largest metabolic profiling project¹ of 50.000 samples.
  2. Installed our biomarker profiling platform for on-site operations at one of the world’s top medical universities with aim to measure of hundreds of thousands of biobank blood samples.
  3. Achieved solid operations in the academic research market to support our journey to clinical diagnostics.
  4. Secured 8M USD to initiate a large R&D project to complete accreditations and standardizations, and accelerating taking our solution to routine healthcare globally.
  5. Engaged strategic ownership bringing us direct access to clinical healthcare and regulative expertise.
  6. Agreed to pilot our biomarker service for clinical use in public and private healthcare in Finland in 2017.
  7. Been accepted in the world’s leading health innovation accelerator, NYC based StartUp Health, to access the best healthcare innovation networks.


The year 2017 will be transformative, as we expand to clinical diagnostics. We will:

  1. Finalize the regulatory approval and CE accreditation for our technology for Europe.
  2. Pilot our technology in healthcare settings in Finland and the UK.
  3. Market and sell our solution across Europe to further demonstrate the clinical impact potential.
  4. Initiate the project to get regulatory approval to operate in the US market (i.e. FDA approval).


This allows the technology to be distributed through healthcare centers in private and public healthcare. The technology platform can be taken to customer’s premises anywhere in the world – the proof of concept is already operational in the UK.

We will seek major capital investment in spring 2017 with potential investors from the Nordics, the UK, North America, Singapore and Japan. The unique technology proven by peer-reviewed science and planned future investment instruments formulate a solid basis to take our solution to healthcare and enter the new era of precision medicine ².

Who will take these actions?

The key principle in data driven healthcare is that the outcomes can be improved the more actors are involved. We have followed this principle since the beginning with the following results:

University collaboration: Working with world-leading research institutions and universities producing novel science in various fields of medicine, delivered the world’s largest metabolic profiling project of 50.000 samples, to date we have analysed already nearly 500.000 samples with our technology. The resulted 100 peer-reviewed articles demonstrate the predictive power of our technology.

Biobanks: Working with the most advanced biobanks in the world to utilize the possibilities of comprehensive clinical data and unprecedented sample amounts to support novel medical science and clinical market entry.

Investments: Secured $8M to invest in business growth and to initiate a large R&D project to complete accreditations standardizations and software improvements.

Now we are looking to expand this list of actors in the following way:

Healthcare: Establish contacts to leading doctors in university hospitals and initiating multiple clinical trials to show the power of comprehensive biological data in healthcare settings.

Government initiatives: Provide expert opinions to support policy making in health, promote technological advancements and societal savings, demonstrate the benefits of disruptive innovations, participate the processes in creating national guidelines, facilitate the development process towards embracing disruptive innovations.

Industrial partners: Partner with industrial companies to expand the distribution network of the technology. Integrate the technology to existing solutions in healthcare to enhance the value of routinely used healthcare solutions.

Financial market: Establish solid investments to accelerate growth in the healthcare domain. Ensure that availability of the technology is not delayed due to lack of investment. Offer innovative funding solutions for customers to enable quick ramp-up.

With the support of our key partners we can take this unique global scale initiative to accelerate the new era of preventive healthcare in heart disease and diabetes.

Target geography

The need for preventive medicine for heart disease and diabetes is global. The rising costs of care is putting the spotlight on preventive measures such as clinical diagnostics (e.g. cholesterol tests), to reduce acute events caused by these diseases.

North America is estimated to account for the largest share of the global cholesterol testing services and Europe the second-largest. Also the GCC and Asian countries are driven by factors such as the growing prevalence of heart disease and obesity, rising awareness towards preventive healthcare, and improving healthcare infrastructure. Thus, we see the major target geographies of our solution being the US, Europe, the GCC, Japan, and China.

We already operate globally in the academic research market. For healthcare, our entry point is the laboratory cholesterol testing market in Europe. We will enter the market from our ‘home’ markets: Finland and the UK. We aim to replace a significant share of laboratory cholesterol testing with our solution in Europe during 2017-2019. We will enter the US market in 2018, and the Asian market in 2019.

What do you expect are the costs associated with piloting and implementing the solution, and what is your business model?

We have two operational business models. Both are based on price / sample model, which is the clinical standard. We can centralize the sample analysis by running our own laboratories (customer ships the samples to our laboratory) or by setting up the laboratory at customer’s premises. Neither option requires CAPEX investments from the customer and are therefore straightforward to implement. Customer only commits to a pre-agreed number of sample analysis, which is generally well known in clinical settings.

We are routinely running these business models in academic research and we will continue to deliver our service globally by providing analysis as a service and on premises. Next we aim to enter the clinical market by replacing laboratory cholesterol testing with our analysis service (analysis as a service, charging per sample).

We have acquired funding for necessary product development and regulatory approvals for the European market and for clinical pilots in Finland to demonstrate our operational capability and value during 2017. In the next phase, we seek funding through capital investment for global expansion. The first step of the plan is the estimated to require 30M USD investment, the overall estimated investment is 100M USD. 

Piloting phase

  1. Personalized risk prediction model development in cooperation with national biobanks of Finland
  2. Clinical pilots in the UK (NHS)


Implementation phase

  1. Global delivery capability development
  2. Integration to national healthcare systems and preventive healthcare initiatives in: US, Europe, GCC, China, Japan

Timeline

To introduce the solution for healthcare, the most critical pre-requisite is getting regulatory approval (CE in Europe, FDA in USA) for the technology. We are finalizing the process of obtaining the European-wide regulatory approval (i.e. EU IVD, CE) in Q2 2017.

To demonstrate both the clinical applicability and value of our solution, we will pilot our technology in operational diagnostic use with a Finnish healthcare provider. This pilot will be run in parallel with the operational tests enabling us to pilot already before full CE accreditation. We will cooperate with leading biobanks and academic partners to develop the risk models enabled by our technology and comprehensive clinical data. Over the next 3 years we will enter the US, European, and Asian clinical markets with our technology.

2017: Clinical pilots in Finland, CE accreditation, clinical market entry, risk model development based on biobank data
2018: Clinical pilots in the UK, personalized risk prediction model for Europe, FDA approval
2019: Personalized risk prediction model for US, GCC, China and Japan
2020-: Global preventive healthcare for heart disease and diabetes

Related solutions

References

¹ Progress Lies in Precision
Science 2016 353(6301)
http://science.sciencemag.org/content/353/6301/731.full

Key publications utilizing the presented technology:

² Separately-funded assays in baseline samples of 50,000 INTERVAL donors
http://www.phpc.cam.ac.uk/ceu/files/2014/05/WebAppendix_for_NIHR_BTRU_application_Danesh_Cambridge.pdf

Quantitative Serum Nuclear Magnetic Resonance Metabolomics in Cardiovascular Epidemiology and Genetics
Circulation Cardiovascular Genetics 2015 8(1) 192-206

High-throughput serum NMR metabonomics for cost-effective holistic studies on systemic metabolism
Analyst 2009 134(9) 1781-5

Genome-wide study for circulating metabolites identifies 62 loci and reveals novel systemic effects of LPA
Nature Communications 2016 7 111-22

High-throughput quantification of circulating metabolites improves prediction of subclinical atherosclerosis
European Heart Journal 2012 33(18) 2307-16

Metabolite profiling and cardiovascular event risk: a prospective study of 3 population-based cohorts
Circulation 2015 131(9) 774-85

Biomarker profiling by nuclear magnetic resonance spectroscopy for the prediction of all-cause mortality: an observational study of 17,345 persons
PLoS Medicine 2014 11(2) e1001606

The biomarker GlycA is associated with chronic inflammation and predicts long-term risk of severe infection
Cell Systems 2015 1(4) 293-301

Diabetes risk and amino acid profiles: cross-sectional and prospective analyses in a South Asian and European cohort. The SABRE Study (Southall and Brent Revisited). Ethnicity, amino acids and diabetes
Diabetologia 2015 58(5) 968-79

Hyperglycemia and a common variant of GCKR are associated with the levels of eight amino acids in 9,369 Finnish men
Diabetes 2012 61(7) 1895-902

Glycerol and fatty acids in serum predict the development of hyperglycemia and type 2 diabetes in Finnish men
Diabetes Care 2013 36(11) 3732-8

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Solution Summary
Disruptive blood screening technology
Team Solution: Only members listed on the Solution's Contributors tab will be able to edit this Solution. Members can request to join the Solution team on the Contributors tab. The Solution owner can open this Solution for anyone to edit using the Admin tab.  
By:  Brainshake
Challenge: Cure: Chronic Diseases
How can we help people prevent, detect and manage chronic diseases, especially in resources-limited settings?