COVID-19 Challenge — Point of Care and Home Diagnostic Kit for COVID-19

From: Innovation, Science and Economic Development Canada

The Public Health Agency of Canada (PHAC) and National Research Council (NRC) are seeking a solution that will diagnose individuals affected by COVID-19 within 3 days of the start of their symptoms using a sample, other than a nasopharyngeal swab, with a rapid single-use home testing kit analogous to a home pregnancy test.

Challenge Sponsor: Public Health Agency of Canada (PHAC) and the National Research Council of Canada (NRC)

Funding Mechanism: Grant

Opening date: April 5, 2020
Closing date: April 21, 2020, 17:00 Eastern Daylight Time

Prospective applicants should refer to the Innovative Solutions Canada Grant Instructions and Procedures document.

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Challenge

Problem Statement

The emergency of SARS-CoV-2 has, in short order, reshaped Canadian society. In a matter of weeks, Canadians from coast to coast have had to engage in social distancing, while at the same time health care systems are threatened by a potential influx of severe cases, while the economy is distressed by a forced prorogation of economic activity. The response to this pandemic hinges on an all-of-society response, with frequent and timely lab testing as a central pillar of this work.

While molecular based detection of the virus remain as the mainstay of testing, this approached is hampered by intermittent shortages of swabs, viral transport media and molecular reagents. The Public Health Agency of Canada is thus in need of a novel approach to diagnostic testing that can rapidly and accurately detect the virus or a component of the virus that causes COVID-19 without the need for traditional reagents and highly specialized equipment. Such a device can facilitate diagnosis and care (particularly in remote areas), while expanding into non-traditional clinical environments or home settings, enabling the broadest potential response to this monumental crisis.

Desired outcomes and Considerations

A revision has been made to Essential (Mandatory) Outcome number 4. The revisions are highlighted.

Essential (mandatory) Outcomes

The proposed solution must:

Phase 1 requirements:

  1. Detect SARS-CoV-2 (the causative agent of COVID-19) within the first 72 hours of symptoms with an accuracy similar to molecular RNA detection.
  2. Results should be available 20 minutes (at most) from sample collection to diagnosis.
  3. The sample input must be one other than a nasopharyngeal swab.
  4. The device must be single use The following section has been added as a new requirement. or reusable as long as decontamination following the usage is easy and there is no complex disposal procedure of the previous test (e.g., it does not result in toxic waste). End of section.
  5. The device price cannot exceed $40.
  6. The device must be usable by a lay person with no technical training (although an instruction sheet is allowable).
  7. The interpretation of the result should be easy for a lay person (i.e. negative or positive).
  8. Each device should possess a unique identifier (i.e serial code, QR or bar code).

Phase 2 requirements:

  1. Demonstrate, at the end of Phase 2, clinical efficacy data derived from a clinical trial comparing the device to the performance of the current gold standard. The gold standard is molecular detection by nasopharyngeal swab collection using two gene targets (the E and RdRp genes). Gold standard testing can be performed by the National Microbiology Laboratory or an accredited lab provided the samples are submitted in a blinded and anonimised fashion. Trial design should follow a non-inferiority trial design.

Note:

Applicants are reminded that under Section D, Question 1a (Scope) of the Phase 1 Proposal Submission Form, proposals must describe how solutions clearly meet all nine of the Essential (Mandatory) Outcomes listed in this section. However, applicants should focus their response to Question 5 (Phase 1 Project Plan) by elaborating a project plan that addresses Essential (Mandatory) Outcomes 1-8. Essential (Mandatory) Outcome 9 can be addressed during Phase 2 work.

Additional Outcomes

The proposed solution should:

  1. The result of the test should be easily uploaded to the public health system / network connected to enable monitoring and action. The result should also be easily uploaded as anonymous if desired.
  2. Interpretation of the device result would benefit from assistance using commonly available technology, such as smart phone cameras, to facilitate interpretation of positive or negative results and record the result.

Background and Context

Currently, COVID-19 testing is being performed by molecular detection using RT-PCR technology. This is occurring in large hospital-based or public health laboratories. This introduces several challenges, including sample routing (from patient to lab), requires specialized equipment and reagents (which can be in short supply) and requires specialized work force (which is vulnerable to illness from the pandemic). While there has been a concerted effort to mitigate these risks, they are insufficient. For example, decentralization of the testing to front-line labs increases capacity but also strains reagent resources. Alternatively, the validation and implementation of point-of-care diagnostics can extend capacity, provide rapid accurate results, and lower technology needs, but still require specialized instrumentation. This limits the ability to disseminate testing as far as would be ideal.

Maximum grant value and travel

Multiple grants could result from this Challenge.

Funding of up to $300,000.00 CAD for up to 3 months could be available for any Phase 1 grant resulting from this Challenge.

Estimated number of Phase 1 grants to be awarded: 2

Funding of up to $2,000,000.00 CAD for up to 12 months could be available for any Phase 2 grant resulting from this Challenge. Only eligible businesses that received Phase 1 funding could be considered for Phase 2.

Estimated number of Phase 2 grants to be awarded: 1

This disclosure is made in good faith and does not commit Canada to award any grant for the total approximate funding. Final decisions on the number of Phase 1 and Phase 2 awards will be made by Canada on the basis of factors such as evaluation results, departmental priorities and availability of funds. Canada reserves the right to make partial awards and to negotiate project scope changes.

Travel

For Phase 1 it is anticipated that meetings will primarily take place by videoconference/teleconference with a final review meeting with the successful applicant(s) in Winnipeg, Manitoba at the National Microbiology Laboratory (PHAC).

Kick-off meeting

At the beginning of Phase 1, the kick off meeting will be held through videoconference.

Progress Review Meeting(s)

Any progress review meetings will be conducted by videoconference or teleconference.

Final Review Meeting

Phase one reports and demonstrations of feasibility will be done in person at Winnipeg, National Microbiology Laboratory (PHAC).

Eligibility

Solution proposals can only be submitted by a small business that meets all of the following criteria:

  • for profit
  • incorporated in Canada (federally or provincially)
  • 499 or fewer full-time equivalent (FTE) employeesFootnote *
  • research and development activities that take place in Canada
  • 50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in CanadaFootnote *
  • 50% or more of its FTE employees have Canada as their ordinary place of workFootnote *
  • 50% or more of its senior executives (Vice President and above) have Canada as their principal residenceFootnote *

Evaluation Criteria

The applicant must complete the Challenge Stream Electronic Submission Form with a degree of information sufficient to enable Canada's assessment of the proposal against the criteria and the Evaluation Schema. The information must demonstrate how the proposal meets the criterion.

Part 1: Mandatory Criteria

Proposals must meet all mandatory criteria identified by achieving a "Pass" in order to proceed to Part 2. Proposals that do not meet all mandatory criteria will be deemed non-responsive and given no further consideration.

Mandatory Criteria

(Applicant's proposal must address)

Question 1 a: Scope

Describe the proposed solution and demonstrate how it responds to the challenge. Include in your description the scientific and technological basis upon which the solution is proposed and clearly demonstrate how the solution meets all of the Essential (Mandatory) Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice.

Evaluation Schema (Mandatory - Pass/Fail)

Pass

The Applicant's proposed solution is clearly articulated, within the scope for the challenge and addresses all Essential (Mandatory) Outcomes (if identified) in the Challenge Notice.

Fail

The proposed solution is articulated as out of scope for the challenge.
OR
The proposal does not clearly demonstrate how the proposed solution addresses all Essential Outcomes listed in the challenge.
OR
The proposed solution is poorly described and does not permit concrete analysis.
OR
There is little to no scientific and/or technological evidence that the proposed solution is likely to meet the challenge.

Question 2: Current Technology Readiness Level (TRL)
  • Indicate the current TRL of the proposed solution. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
  • Describe the research and development activities that have taken place to bring the proposed solution to the stated TRL.
Evaluation Schema (Mandatory - Pass/Fail)

Pass: The Applicant has demonstrated that the proposed solution is currently between TRLs 1 and 6 (inclusive), and provided justification by explaining the research and development (R&D) that has taken place to bring the solution to the stated TRL.

Fail: The Applicant has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 6 (inclusive) including:

  • There is insufficient/no evidence provided for TRL judgment.
  • The solution involves the development of basic or fundamental research.
  • The solution is demonstrated at TRL 7 or higher.
  • Insufficient/unclear/no justification explaining the R&D that took place to bring the solution to the stated TRL.
  • The explanation simply paraphrases the description of a given TRL level.
Question 3a: Innovation

Demonstrate how the proposed solution meets one or more of the ISC definitions of innovation below:

  • An inventionFootnote *, new technology or new process that is not currently available in the marketplace.
  • Significant modifications to the application of existing technologies/components/processes that are applied in a setting or condition for which current applications are not possible or feasible.
  • An improvement in functionality, cost or performance over an existing technology/process that is considered state-of-the-art or the current industry best practice.
Evaluation Schema (Mandatory – Pass/Fail)

Pass:

The Applicant has demonstrated that the proposed solution meets one or more of the ISC definitions of innovation.

Fail:

  • Applicant has not provided sufficient evidence to demonstrate that the proposed solution meets any of the ISC definitions of innovation; OR
  • Applicant has demonstrated that the proposed solution is an incremental improvement, "good engineering", or a technology that would go ahead in the normal course of product development (i.e. the next version or release).
Question 3b: Advance on State of the Art

Describe in detail the competitive advantages and level of advancement over existing technologies. Where appropriate, name existing technologies as well as potential substitutes or competitors.

To demonstrate this, proposals should include the following information:

  • Improvements (minor or major) over existing technologies or substitutes. Use direct comparison.
  • How the proposed innovation will create competitive advantages in existing market niches or market spaces.
Evaluation Schema (Mandatory Criteria – Pass/Fail + Points)

0 points/Fail:

  • The Applicant has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR
  • The proposed solution improves minimally upon the current state of the art, though not sufficiently enough to create competitive advantages in existing market niches; OR
  • The stated advancements are described in general terms but are not substantiated with specific, measurable evidence.

5 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers one or two minor improvements to existing technologies, including available competing solutions, that have potential to create competitive advantages in existing market niches.

12 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers three or more minor improvements to existing technologies, including available competing solutions, that together are likely to create competitive advantages in existing market niches; OR
  • The Applicant has demonstrated that the proposed solution offers one significant improvement to existing technologies that is likely to create competitive advantages in existing market niches

20 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers two or more significant improvements to existing technologies, including available competing solutions that are likely to create competitive advantages in existing market niches and could define new market spaces; OR
  • The Applicant has demonstrated that the proposed solution can be considered a new benchmark of state of the art that is clearly ahead of competitors and that is likely to define new market spaces

Part 2: Point-Rated Criteria

Proposals must meet the overall minimum pass mark of 50% to be deemed responsive. Proposals that do not achieve the minimum pass mark will be declared non-responsive and given no further consideration.

Point-Rated Criteria

(Applicant's proposal to address)

Question 1b: Scope

Demonstrate the scientific and technological basis of how the proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice. If no Additional Outcomes are identified in the Challenge Notice, text entered in this section will not be considered.

If no Additional Outcomes are identified in the Challenge Notice, Applicants will receive 10 points.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the solution will address any of the Additional Outcomes. 0 points
  2. Information provided clearly demonstrates that the solution will address some (<50%) of the Additional Outcomes. 3 points
  3. Information provided clearly demonstrates that the solution will address most (50% or more) of the Additional Outcomes. 6 points
  4. Information provided clearly demonstrates that the solution will address all (100%) of the Additional Outcomes. 10 points
Question 4: Phase 1 Science and Technology (S&T) Risks

Describe potential scientific and/or technological risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 5: Phase 1 Project Plan

Demonstrate a feasible Phase 1 project plan by completing the table.

  • Indicate if any milestones and activities will be completed concurrently
  • Indicate the estimated exit TRL at the completion of Phase 1. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate a feasible project plan for Phase 1 and/or the project plan exceeds the maximum duration indicated in the Challenge Notice. 0 points
  2. Project plan for Phase 1 is conceivably feasible but not clearly demonstrated and/or includes gaps. 10 points
  3. Information provided clearly demonstrates a feasible project plan for Phase 1. 20 points
Question 6: Phase 1 Project Risks

Describe potential project risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Applicants should address the following risks, as applicable:

  • Human Resources
  • Financial
  • Project Management
  • Intellectual Property
  • Other project-related risks

Note to Applicants: S&T risks should not be included in this section. Question 4 addresses S&T risks.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 7: Phase 1 Implementation Team

Demonstrate how the project implementation team has the required management and technological skill sets and experience to deliver the project plan for Phase 1 by completing the table. A member of the implementation team can have more than one role.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 0 points
  2. Information is provided but there are minor gaps in required management and/or technological skill sets and/or experience to deliver the Phase 1 project plan. 10 points
  3. Information provided clearly demonstrates that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 20 points
Question 8: Inclusivity

If your business were to receive funding from Innovative Solutions Canada, describe what actions (e.g., recruitment strategy, internships, co-op placements, etc.) might be taken in Phase 1 to support the participation of under-represented groups (e.g., women, youth, persons with disabilities, Indigenous people, visible minorities) in the research and development of the proposed solution. Each Applicant in their response to this question must focus only on describing relevant programs, policies, or initiatives that it currently has in place or would put in place to support the R&D effort in Phase 1.

Note: Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response.

Evaluation Schema (Point-Rated)
  1. No description and/or concrete examples of actions provided that would be taken to encourage greater participation of under-represented groups. 0 points
  2. A description and concrete examples of actions to encourage greater participation of under-represented groups provided.5 points
Question 9: Phase 1 Financial Proposal

Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.

Evaluation Schema (Point-Rated)
  1. Insufficient information provided and/or information provided significantly lack credibility. Does not demonstrate a realistic financial proposal for the Phase 1 project plan. 0 points
  2. Information is provided but some costs lack credibility and/or are unclear for the Phase 1 project plan. 7.5 points
  3. Information provided contains credible elements to clearly demonstrate a realistic financial proposal for the Phase 1 project plan. 15 points
Question 10: Phase 1 Financial Controls, Tracking and Oversight

Describe the financial controls, tracking and oversight that will be used to manage the public funds throughout Phase 1. Applicants should indicate if an individual or firm will be managing the public funds and provide their credentials and/or relevant experience.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate the Applicant's ability to manage public funds in Phase 1. 0 points
  2. Information provided is vague and/or contains gaps. The Applicant has some controls, tracking and/or oversight in place to manage the public funds in Phase 1. 5 points
  3. Information provided clearly demonstrates that the Applicant has strong financial controls, tracking and oversight to manage public funds in Phase 1. 10 points
Question 11: Phase 2 Overview

Demonstrate a realistic overview for the prototype development plan if selected to participate in Phase 2.

Responses should include:

  • key tasks
  • estimated cost for materials
  • human resources
  • project risks and mitigation strategies

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has contemplated a realistic overview for the Phase 2 prototype development. 0 points
  2. Information provided demonstrates a conceivably realistic overview for Phase 2 prototype development, however there are gaps and/or the strategy is vague. 6 points
  3. Information provided demonstrates that the Applicant has a clear and realistic overview. 12 points
Question 12: Commercialization Approach

Demonstrate a realistic overall commercialization approach/business model that can successfully take the technology/service to market, and how the technology/service will help you develop and sell other products.

Responses should include:

  • Target markets (excluding Government of Canada)
  • Non-ISC funding sources
  • Transition to a commercially-ready product or service
  • Any other indicators of commercial potential and commercial feasibility

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the proposed solution has commercial potential. 0 points
  2. Some information provided to demonstrate that the proposed solution has commercial potential, however there are gaps in the commercialization approach. 6 points
  3. A realistic commercialization approach is provided that demonstrates that the proposed solution has commercial potential. 12 points
Question 13: Resulting Benefits to Canada

Describe the benefits that could result from the commercialization of the proposed solution. Applicants should consider the potential benefits using the following three categories and provide justification for each claim:

  • Innovation Benefits: Expected contribution towards the enhancement or development of new industrial or technological innovations within your firm. Responses could include: potential spillover benefits, creation of intellectual property, impact on productivity of the new technology, etc.
  • Economic Benefits: Forecasted impact on the growth of Canadian firms, clusters and supply chains, as well as its expected benefits for Canada's workforce. Responses could include: number of jobs created, number of high-paying jobs, investment in Canada's economy, etc.
  • Public Benefits: Expected contribution to the broader public to the degree that the solution is expected to generate social, environmental, health, security or other benefits to Canada. Responses could include: solution-related environmental benefits, solution-related accessibility benefits, and solution-related impact on Indigenous communities.
Evaluation Schema (Point-Rated)
  1. Innovation Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  2. Economic Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  3. Public Benefits.

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

Questions and answers

All incoming questions regarding this specific challenge should be addressed to solutions@canada.ca.

All enquiries must be submitted in writing no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.

You can also consult the Frequently asked questions about the Innovative Solutions Canada Program.

glossary is also available.

I would like to know if I propose a solution to meet this request, but which would not be for single use but reusable at will and could be used for other purposes. In this offer, it is mentioned for single use. Do I still stay in the criteria with a reusable solution?

A reusable device will be acceptable as long as decontamination following the usage is easy and there is no complex disposal procedure of the previous test (e.g., toxic waste).

Does the lab in Manitoba provide access to SARS-CoV-2 samples for direct measurement?

This would depend on the sample type. SARS-CoV-2 is a containment level 3 organism, so the necessary containment would need to be in place to receive live virus. We can make inactivated virus available, upon request.

Instead of nasopharyngeal swabs, is the use of other swabs also acceptable? such as Oropharyngeal (OP) swabs, Nasal swabs, and Nasal mid-turbinate (NTM) swabs? Detecting the SARS-CoV-2 early on will require sample collection at the primary location, as the virus is not normally present in other areas. In addition, due to the delay in the initial immune response, it is very challenging to detect IgM antibodies in blood/serum samples with high sensitivity only within 3 days of the infection.

Yes other swab types would be acceptable.

Can we mix multiple sample types (from single patient) and run then on a single test (<20 min)?

Yes that would be acceptable.

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