COVID-19: High Performance Low Cost Detection of Biomarkers

National Research Council of Canada (NRC) is seeking robust cost effective point-of-care testing innovations. The innovations should allow qualitative or quantitative detection of one or multiple biomarkers, in a single specimen, at low picograms per milliliter concentrations via non-invasive methods to enable screening or monitoring health status by minimally trained users.

Challenge sponsor:
National Research Council of Canada (NRC)

Funding mechanism:
Grant

Opening date:
November 25, 2021

Closing date:
December 23, 2021 14:00 Eastern Standard Time

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

Challenge

Problem statement

There are numerous biomarkers present at low concentrations whose detection can provide valuable information pertaining an individual's health. Examples include but are not limited to; (i) antigens derived from SARS-CoV-2 whose presence in asymptomatic individuals is indicative of exposure or infection, (ii) cardiac troponin which when elevated is indicative of cardiac risk, (iii) various cytokine markers related to the "cytokine storm" seen in COVID-19 patients.

NRC is seeking innovations which can be used in diverse settings by minimally trained users to assess a human sample for the presence or quantity of one or multiple biomarkers, using a single device (i.e. multiplex detection) as to provide information to inform a subsequent course of action. The course of action may be that an individual seeks specific medical care, or following a proactive screening for an infectious disease and not needing to modify their behavior, or that they are suspected to have been exposed to an infectious organism and that they need to seek further testing or care.

While there are marketed products which can detect low concentrations of the aforementioned as well as other biomarkers, those products are confined to laboratories. The current COVID-19 pandemic has illustrated that there is significant need for an innovation which would allow individuals, or health care teams to test samples obtained via non-invasive means for the presence of one or multiple biomarkers present at low concentrations outside of traditional settings. The ability to detect and or quantify such biomarkers at low concentrations in nontraditional setting could prevent inadvertent spread of disease, or remote evaluation of individuals thus decreasing the burden on health care systems. Unfortunately, we do not currently have appropriate innovations.


Desired outcomes and considerations

Essential (mandatory) outcomes

Phase 1

Proposed solution must:

  1. Provide background on the biomarker(s) the innovation is intended to measure. This would include:
    • Description of the settings in which the biomarker(s) is currently tested and how individuals and the health care system would benefit from the ability to test for the biomarker(s) in non-traditional settings.
    • Description of the actionable result which would be possible by having the result delivered at point-of-care.
  2. Use a sample which can be reproducibly obtained via non-invasive sampling methods, i.e. fingerstick whole blood, swabs samples, saliva, or urine.
  3. Have minimal or no pre analytical steps.
  4. Provide a result within 15-25 minutes of initiating a test.
  5. Be able to be accurately used by an individual after either:
    • Reading brief instructions written at a grade seven reading level
    • Reviewing a pictorial set of instructions
    • Viewing a short video (less than 2 min) using a mobile device connected to a wireless network.
  6. Detect or measure a biomarker(s) at a physiological relevant concentration. The lower bound of the reference range or limit of detection must be at least 50 pg/ml, but ideally 10 pg/ml when measured in the clinical relevant sample matrix.
  7. Illustrate through conduct of studies based on relevant protocols described by Clinical Laboratory Standards Institute (CLSI) that the innovation is sensitive (meets the required LoD, LoQ, and linearity as applicable), and specific in the presence of relevant exogenous interfering substance. See reference for samples of CLSI standards.
    • The studies must be performed using the sample matrices as per the intended use. The samples can be contrived samples.
  8. Be designed to be shipped and stored at 2-30 degrees Celsius;
  9. Cost of the consumable device can't exceed $20 to the end users.
  10. If the innovation requires a piece of equipment to facilitate obtaining a result, the equipment must be either (1) readily available by consumers, i.e. a mobile phone, or (2) be able to be installed in public venues such as, but not limited to, drug stores or pharmacies, schools, or workplaces. Any such piece of equipment must not require frequent servicing, and must be able to run a self-diagnostic and alert the user that the equipment is ready for use or that it cannot be used.
  11. The consumable must not be classified as a dangerous good for the purpose of shipping.
Phase 2

Proposed solution must:

  1. Illustrate reproducible utilization by intended users.
    • The studies must performed using the sample matrices as per the intended use. Samples can be contrived samples. CLSI standards should be referenced when designing such studies.
  2. Illustrate through design and conduct of studies that there is insignificant risk of erroneous result by errors made by the user.
  3. Illustrated minimum shelf life of 3 months at room temperature.
  4. Develop manufacturing plans for the innovation which would provide the capability to produce at least three batches of 2000 units each of the consumable and three pieces of equipment (if required).
  5. Achieve state of development to prepare an Investigational Testing Authorization Application to Health Canada (see reference in the background section), in particular device characteristic illustrating that state of development warrants clinical studies.

Note: Applicants are reminded that under Question 1a (Scope) proposals must describe how solutions clearly meet all 16 of the Essential (Mandatory) Outcomes listed in this section. Applicants should focus their Phase 1 project plan on demonstrating the feasibility of Essential Criteria 1-11. Applicants can focus on Essential Criteria 12 to 16 during Phase 2 work.

Additional outcomes

The proposed solution should:

  1. Simultaneously detect or measure multiple biomarkers via analysis of a single specimen.
  2. Be working within a quality system such as ISO 13485.
  3. Describe how the innovation could be used to detect or quantify biomarkers other than the one described for article #1 of the Essential Outcomes.

Background and context

Innovators have developed in vitro diagnostics (IVD) which can be used in non-traditional settings. These include tests for infectious disease such as malaria, HIV, and flu. Innovators have also developed tests for blood chemistry, and cardiac markers. These innovations have averted continual spread of infectious disease, facilitated diagnosis of infection leading to improved outcomes, and in the case of blood chemistry and cardiac markers tests have allowed rapid triage and treatment.

At the same time, IVD for use in laboratories have advanced significantly with respect to their performance, i.e. ability to detect lower amounts of biomarkers, ability to quantify those biomarkers, and ability to simultaneously detect more than one biomarker. However laboratories are often inaccessible, and the point-of-care tests have not developed at the same rate as tests done in laboratories, thus, leaving some populations continually or intermittently unserved.

One barrier to innovation is that as new innovations are being developed, appropriate time is not dedicated to verifying the innovation can produce required results via conduct of appropriately designed studies. In these instances the innovations can advance to late stages, at great cost, only to fail. This can cause delays but more often may lead to end of a small innovative company. NRC is seeking proposals from innovative firms to develop and test new innovations. Testing of these innovations via well-established clinical and laboratory standards will help innovators de-risk innovation leading to more rapid development of solutions to address clinical need.

References:

Investigational Testing Authorization Application Guidance

CLSI Ep06
CLSI EO07
CLSI POCT 15
ISO 20916:2019

Maximum grant value and travel

Multiple grants could result from this Challenge.

Phase 1:

  • The maximum funding available for any Phase 1 Grant resulting from this Challenge is : $300,000.00 CAD
  • The maximum duration for any Phase 1 project funded by a grant resulting from this Challenge is up to 6 months
  • Estimated number of Phase 1 grants: 2

Phase 2:

  • The maximum funding available for any Phase 2 Grant resulting from this Challenge is : $2,000,000 CAD
  • The maximum duration for any Phase 2 project funded by a grant resulting from this Challenge is up to 12 months
    • Note: Only eligible businesses that have completed Phase 1 could be considered for Phase 2.
  • Estimated number of Phase 2 grants: 1
    • Note: Selected companies are eligible to receive one grant per phase per challenge.

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

Due to Covid-19 restrictions, the kick-off meeting and final review meeting will have the flexibility of being a video or teleconference.

Kick-off meeting

A project kick-off meeting will be conducted by video conference or teleconference.

Progress review meeting(s)

Progress review meetings will be conducted by videoconference or teleconference.

During the project, NRC may request a site visit to the applicant's facilities, at NRC's expense, to better understand the technology/manufacturing processes and validate production facilities. Any site will respect pandemic-related health and safety protocols, procedures, and approvals.

Final review meeting

Virtual meeting- A final review meeting will be conducted virtually, via videoconference or teleconference.

The review and evaluation of the proof-of concept to verify fit, comfort and sound reduction of the samples will be conducted by an independent focus group, comprised of participants selected by NRC and its partner agencies, at NRC's expense.

Applicants that demonstrate successful completion of Phase 1 will be invited to submit a proposal for Phase 2.

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@ised-isde.gc.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.