Problem

More than 100,000 people are being infected every day with the Coronavirus, each spreading SARS-CoV-2 to up to three others, without knowing. After weeks of complete lock-down, Europe is at a critical turning point: Should we continue to protect the health of our people, or save our economy?

South Korea and Singapore have shown what it takes to combine both efforts: Massive testing. However, with our current testing approach in place, Europe is still facing major challenges:

  • Infected patients have to leave quarantine to get tested outside, potentially spreading the virus
  • Particularly high risk of infection in public transport or at test centers
  • Particularly high risk of infection for healthy patients
  • Particularly high risk of infection for medical personnel on all front lines
  • Testing requires tons of scarce protective equipment
  • Centralized approach overburdens healthcare systems in major cities and impedes testing in rural regions

How can we sustainably scale up testing while simultaneously protecting patients, medical personnel and the healthcare system?

Solution

We need a joint European approach to testing for COVID-19!

At CoronaOne, we have developed a solution for comprehensive testing: Remote testing patients can perform themselves right from home. With a scalable infrastructure and a specially-designed home-swab-kit, patients can safely take a sample for analysis without leaving quarantine and without posing a risk to others:

User Journey

  1. You suspect you have been infected with COVID-19. You visit our website and make a doctors appointment online for a video consultation. In case your doctor decides it is necessary to perform a test on the virus, we send you our home-swab-kit via mail.
  2. As you open the box, you wash your hands and put on the gloves. After that, you check your data on the laboratory request paper and write your details onto the swab tube. Afterwards, you are advised by the illustrated instruction to use the tongue stick and the swab specimen to collect viral material from your oropharynx (throat). The sample is packed into a small plastic bag and a bigger laboratory bag, together with the laboratory request paper it goes back into the box.
  3. Until pickup, the box is stored in your fridge for cooling purposes. A dangerous goods pickup service collects the sample in the box from the your doorstep the next day to bring it to our partner laboratory. Your doctor and you can check the results online within 24 hours on the laboratory website or via phone.

The process is also explained in our pitch deck

Prototype Home-Swab-Kit
We developed a fully-functional prototype of our home-swab-kit (pictures). All components inside the home-swab-kit are sterile. All medical products inside the home-swab-kit are CE-certified. Every home-swab-kit consists of:

  • the box
  • one pair of gloves
  • one tongue stick
  • one swab
  • one plastic bag (small) (UN3373)
  • one plastic bag (big) (UN3373)
  • one biohazard goods sticker (UN3373)
  • one illustrated instruction
  • one disclaimer & welcome letter
  • one package insert

All components can also be found here under our GitHub project/resources/materials
We uploaded the instructions to our GitHub project/resources/print

Institutional Package
We published all our resources in an institutional package under open-source license. The institutional package contains all information on required materials, print-ready instructions, and an implementation plan. Local authorities, health ministries, and policymakers across Europe can use the information to scale our home-swab-kit approach locally and independently from us. This way, we enable others to expand and implement our solution to their needs.

Our institutional package is published as a GitHub project

Accessibility
Accessibility is a key design principle for us.

  • We design our home-swab-kit to contain all materials patients need, including printed resources. A reliable COVID-19 test can be performed with everything that comes in the box. No computer, smartphone or internet connection is required to use the home-swab-kit.
  • We have designed our website, swab-kit contents, and institutional package with best practices from layout, fonts and color in mind, to provide a comprehensive experience for people from different backgrounds
  • We already provide multi-language support to provide all our resources in English and German. Throughout the upcoming week, we will translate the content of our swab-kit and the institutional package to 10 more languages.

Pictures
Find pictures here

Impact for Society

Our home-swab-kit allows for efficient and effective remote testing and, thus, provides a game-changer in the fight against coronavirus for Europe! With our solution:

  • We make sure patients remain in quarantine even for testing, maximizing ongoing containment efforts
  • We prevent patients from spreading to virus at public places or at test centers
  • We effectively protect healthy individuals from infected patients
  • We effectively protect medical personnel on all front lines
  • We do not need additional protective equipment for testing
  • We free up personnel and resources urgently needed for critical intensive-care patients
  • We provide test access to rural areas and remote regions through decentralized testing capacities
  • We help stabilize our overall public healthcare system

In addition to providing the solution ourselves, we publish all information and instructions in an institutional package as a GitHub project. Institutions and local policymakers across Europe can find everything they need to implement our solution independently in their region. With the institutional package, our solution can be adapted according to the unique and specific country’s needs. It is easy to implement as it uses already existing infrastructure and can be scaled up or down based on demand and medical necessity. This adaptability leads to a sustainable and flexible solution and prevents incurring costs to strained economies.


Our impact reaches far beyond the benefits to the public healthcare system. Our approach lays a path forward for slowing the spread of coronavirus while opening up lock-down measures. This way, we stabilize the economic and political structures in Europe beyond the crisis and protect solidarity in Europe.

On a broader international scale, we are aligned with the UN Sustainable Development Goals

  • Goal #3: Access to good health and well-being for everyone: Provide a high-quality healthcare service in remote and rural areas by delivering the home-swab-kits to patients in quarantine; save lives by early diagnosis and effective containment
  • Goal #9: Innovation and infrastructure: Modernize existing testing infrastructure sustainably by integrating the innovative home-swab-kits into processes; expand access to information and diagnosis
  • Goal #17: Partnerships for the goals: Improve disaster/pandemic control by fostering partnership and policy coherence to provide equal access to testing in peri-urban and rural areas

Scalability and Sustainability

We used combined market knowledge across different industries to create a lean yet scalable solution. Our home-swab-kits are no rocket science; all components and the required infrastructure are readily available across Europe. This is an important and deliberate choice by us to ensure our solution can be rolled out to millions of patients across Europe as fast as possible.

By re-thinking industry paradigms and re-combining the existing components as a home-swab-kit, we create reliable and accessible resources offering patients the chance to correctly and safely perform a test on SARS-CoV-2.

Ready-To-Use Products
We do not create complicated new technology that would take months to get licensed and implemented. Instead, we use ready-to-use, licensed components and combine them in a new way to deliver novel value as a home-swab-kit. The advantage of using existing products is a faster time to market for us, higher scalability, and independence from single suppliers. All products are listed under our GitHub project/resources/materials.

Existing Infrastructure
We build on existing infrastructure to scale our product faster to patients across Europe.

  • For delivery logistics to patients, we partner with DHL, which have the capacity to deliver and pick up millions of packages to any region within Europe within 24 hours. Their logistics processes are robust and offer existing capacity during the corona crisis.
  • For pick-up logistics from patients to labs, we partner with FedEx, which have existing capacity to pick-up millions of packages from most regions within Europe and deliver them to a local lab. FedEx has expertise in home pick-up processes and offers specialized handling for packages with biological substances class B (our class)
  • For analysis, we have started building up a decentralized and transparent network of local labs across Europe. Our pilot so far is only in Germany, together with the labs MVZ Limbach Heidelberg and MVZ Berlin. In future, we plan to link more labs across Europe to our network. This way, test load can be balanced across labs and patient packages can always be sent to the nearest lab with existing capacity.
  • Additional partner information is listed in our Business Plan

Local and Independent Partners
We bring vast market knowledge and industry expertise to the table to build a network of local partners. We have strong knowledge into the suppliers, supply chains and partners for the required components and infrastructure. During the crisis, it is especially important for us that all kit components can be sourced locally, and that infrastructure partners reside regionally :

  • For all components of the home-swab-kit, we were able to find and contract multiple suppliers within Europe, often even multiple suppliers within one country
  • We are in close contact with these suppliers, to identify their dependencies on international trade and raw material.
  • For all components, we also identified at least 3 alternative products that could be used if our suppliers fail or cannot deliver
  • For logistics and delivery, DHL and FedEx offer specialized and country-independent services
  • For laboratory analysis, we plan to scale a decentralized and transparent network of laboratories and link existing laboratories to our service
    With our current components and infrastructure, we have cleared all dependencies to suppliers outside the EU. The home-test-kit can be scaled using only suppliers within the EU.

Sustainability
Our solution integrates well into existing structures and delivers an adaptive, more sustainable approach to testing than existing solutions offer:

  • We do not need to build up new infrastructure that becomes obsolete after the crisis, but use services from existing suppliers and partners. This allows for lean, adaptive and scalable testing
  • Our solution is economically feasible and sustainable. Patients would be willing to pay the small extra charge of the home-swab-kit to get tested from home. Healthcare providers would be willing to pay for the service as this is more cost-effective than offering centralized testing
  • Home-testing for infectious diseases is a paradigm shift that will persist after the crisis. We contribute to validating this novel approach and will build on the learnings to offer similar systems in future (see Beyond the Crisis).

We plan to launch our solution within two weeks to the regions most affected by Covid-19. Within the next 6 months, we expect to reach a scale of up to 100.000.000+ patients. Given the probable seasonal climate effects to Covid-19 and the likely development within the next months, this will be just in time for the massive coming outbreaks to be expected in the coming fall and winter. Additional information about our roll-out plan can be found below.

Validation

Last week, we extensively tested and validated our prototype in a study with over 40 patients at three university clinics in Germany (Dresden, Leipzig, Bonn). The study procedure was as follows:

Attendees:

  • We recruited participants directly from the corona outpatient department of the university clinics
  • When inviting participants, we put a strong focus on risk groups (overweighting older patients, overweighting patients with chronic pre-existing conditions)
  • Participants were sampled representative of society in terms of age and gender

Execution:

  • After a short introduction, patients receive our home-swab-kit and the task of using the home-swab-kit as if it had just been mailed to them at home and as if it would be picked up the next day (realistic)
  • A usability expert watches without commenting or intervening to determine whether the product is fit for purpose and safe
  • A medical doctor watches without commenting or intervening whether the participant has taken the home-swab-kit correctly, deep enough and without contamination

Preliminary Results:

  • 95% of participants accurately collected an oropharyngeal sample
  • 9 out of 10 participants rated the product easy to understand and use
  • A similar concept of self-swab-testing on the coronavirus at home was validated in a US clinical study with 500 participants, with an accuracy rate of 90%. The FDA subsequently approved the concept of self-swab-testing in the US.

Achievements During the Weekend

After a weekend without sleep, hours of user and mentor feedback, we are proud to present our achievements:

  1. A fully functional and optimized prototype of a home-swab-kit that allows for remote testing
  2. Multilingual website and multilingual resources for our concept to increase accessibility across Europe
  3. An open-source package for institutions, ministries and local policy-makers across Europe to implement the concept of home-swab-kits independently from us.

We will submit everything we have worked on before and during the weekend to the certification authorities in Germany tomorrow, and scale our infrastructure for launch.

Roll-out Plan After the Weekend

The following roll-out plan defines our next steps after the weekend. The timeline milestones are from now on in two weeks, in one month, three months and six months.

2 Weeks

  • Achieving full certification for our home-swab-kit .
  • Align and optimize all processes.
  • Acquire five Samedi online doctors.
  • Send out 100 swab-kits.
  • Increase multi-language support to up to 5 languages for enhanced accessibility.
  • Distribute open-source institutional package to EU policy-makers.

1 Month

  • Acquire a packaging partner for scaling.
  • Acquire 100 online doctors.
  • Send out 1000 home-swab-kits.
  • Increase process automation further for scaling.

3 Months

  • Expansion into critical markets FR, ES, IT, set up local infrastructures.
  • Acquire more partners in Germany and foreign markets to ensure growth.
  • Send out 1.000.000 home-swab-kits.

6 Months

  • Expansion into further EU markets, align processes and local infrastructure.
  • Prepare for increased demand during yearly influenza outbreak in fall.
  • Calculate with increased risk of Covid-19 spread of due to seasonal climate in fall and winter.
  • Send out 100.000.000+ swab-kits.

Beyond the Crisis

Remote and safe home-testing is a game-changing approach in fighting the spread of infectious diseases. This paradigm applies to many more infectious diseases than just SARS-CoV-2!

  • Related diseases like the flu pose a smaller, yet eminent risk, every year. Projects like "Flu near you" show the potential of extended testing for these diseases to protect others
  • The spread of STIs (sexually-transferable-diseases) remains as a particular issue in Europe. Patients are often not aware of their symptoms and seek medical advice too late, due to the embarrassment and stigma attached to these infectious diseases. The spread of STIs, especially HIV and HPV, could be dramatically contained by the help of home-tests.
  • Long-term, the concept of home-testing allows for a decentralized and flexible healthcare structure, which even supplies rural areas and remote regions with reliable testing possibilities
  • The risk of a global pandemic will persist, even after Covid-19. The major outbreaks of SARS, MERS, Ebola and Zika within the past two decades have a clear call to action for Europe:
    We need to be prepared for the next global pandemic

Call to Action

We need the support of the European Committee and the European Innovation Council to implement and scale our project in Europe starting from next week!

  • Financial support (EUR 400.000 pre-financing for infrastructure for 1.000.000+ home-swab-kits), see financing
  • Partners for our network of infrastructure providers (especially suppliers, logistics, handling, IT infrastructure), see business plan
  • Support and determination to spread the concept to health ministries and local policy-makers across Europe by direct support from EC and EIC

Resources

Website
GitHub Repository
Business Plan
Financing
Pitch Deck

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