COVID-19 Challenge: Magnetic reagents for detection of COVID-19 and other RNA based molecular diagnostic kits

From: Innovation, Science and Economic Development Canada

The National Research Council Canada (NRC) is seeking a solution for reagents required for nucleic acid sample preparation and rapid and efficient SARS-CoV-2 Ribonucleic Acid (RNA) extraction in order to perform downstream molecular diagnostics of COVID-19 with capability to integrate within existing and/or potential microfluidic platforms for sample-to-answer solutions that can be deployed on the frontline for rapid testing.

Challenge sponsor: National Research Council of Canada (NRC)

Funding mechanism: Grant

Opening date: May 26, 2020
Closing date: June 16, 2020, 14:00 Eastern Daylight Time

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

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Challenge

Problem statement

Testing for SARS-CoV-2 in hospitals and diagnostic lab settings has overwhelmed the current workflow as is mainly using manual preparation and experimentation. This has caused severe backlogs of tests to be performed, which is especially critical since samples only possess a finite lifetime and testing delay renders results unreliable. A major cause of the diagnostic shortcomings remains the access to reagents and buffers that allow for rapid viral RNA extraction from patient samples. This is a necessary pre-requisite for downstream diagnostic testing using genetic markers for COVID-19.

Current supply shortages in reagents are directly caused by Canadian dependence on foreign suppliers that can adversely affect the supply chain. Amongst the sample preparation methods highly amenable to automation are ones that based on magnetic bead technology. This allows for less manipulation without need of centrifugation steps. Compared to spin-columns, bead-based technology is also more amenable to microfluidic integration and manipulation. However, the access to compatible reagents for nucleic acid extraction – viral RNA more specifically – continues to pose a serious obstacle. In addition, existing solutions are subject to highly specific protocols that do not possess the ability for on the fly customization and adaptation to existing and potential microfluidic formats.

The NRC is thus in need of Canadian-based access to magnetic-based reagents for sample preparation and viral RNA extraction. This would allow the integration within existing and potential workflows based around automated sample preparation that is desperately needed in diagnostic settings. Addressing this need in the Phase 1 of the  ISC Challenge will immediately fill the capacity gap in government of Canada laboratories and is absolutely required in order to empower larger fabrication capacity in the potential  Phase 2.

Desired outcomes and considerations

Essential (mandatory) outcomes

The solution must:

Phase 1
  1. Demonstrate a method for reagents formulation that is scalable and rapidly adaptable/customizable for different viral threats.
  2. As an immediate test case, demonstrate high specificity for COVID-19 RNA extraction.
  3. Be compatible with most clinical sample types (saliva, sputum, blood, swab, urine, as well as anycell-free media).
  4. Possess the ability to isolate and purify 1 copy/µL or less of viral RNA.
  5. Be rapid, within 15 minutes or less, and require a minimum number of manipulation steps to arrive at final solution.
  6. Introduce a complete solution, including lysis, extraction, washing, and elution into appropriate buffer.
  7. Integrate with downstream molecular diagnostics including RT-qPCR.
  8. Be compatible with most RT-qPCR reagents and buffers.
  9. Provide high extraction efficiencies without leading to false negatives, and be superior to gold standard spin-column methods.
  10. Provide high quality SARS-CoV-2 RNA preps for diagnostic use – devoid of any protein, lipid or other contaminants.
  11. Be customizable to microfluidic platforms for medical device sample-to-answer and sample preparation systems – in particular formulation that can be stored in dry and/or liquid formats in microfluidic polymer cartridges without losing efficacy.
  12. Be compatible with magnetic bead-based automated and high throughput applications.
  13. Integrate seamlessly with most robotic automated systems such as Thermo KingFisher, PerkinElmer Chemagic, and Roche MagNA Pure.
Phase 2
  1. Provide enough fabrication capacity of reagents that can feed fabrication of up to 100 000 tests /month. The reagents formulation must be compatible with room temperature storage for up to 6 months allowing for clinical deployment in distributed testing sites. 
  2. Demonstrate, at the end of Phase 2, clinical efficacy data derived from a clinical trial comparing the buffer/reagents to the performance of the current gold standard for COVID-19 viral RNA extraction for downstream RT-qPCR. The gold standard is spin-column based kits, as well as other magnetic-based kits from well-known suppliers such as Qiagen, ThermoFisher, and Roche. Gold standard testing can be performed by the NRC or an accredited lab provided the samples are submitted in a blinded and anonimised fashion.
  3. Trial design should follow a non-inferiority trial design.
  4. Be amenable to scale-up manufacturing and not be hindered by foreign supply chain issues.
Note:

Applicants are reminded that under Question 1a (Scope) proposals must describe how solutions clearly meet all 17 of the Essential (Mandatory) Outcomes listed in this section. Applicants should focus their Phase 1 project plan on demonstrating the feasibility of Essential Criteria 1-13. Applicants can focus on Essential Criteria 14 to 17 during Phase 2 work.

Additional outcomes

The solution should:

  1. Not be reliant on highly skilled technicians.
  2. Not need additional equipment.
  3. Not need heating, centrifugation, vortexing or other labour-intensive activities.
  4. Integrate workflow for reagents required for complete sample-to-answer nucleic acid diagnostic, including RT-qPCR master mix with appropriate probes and primers.
  5. Be capable of detecting 1 copy/uL or less of viral RNA required for early COVID-19 diagnosis.

 

Background and context

Diagnostic testing for COVID-19 is heavily reliant on the important pre-requisite of viral RNA extraction from clinical samples. This currently the bottleneck for downstream reliable molecular detection using RT-qPCR. In addition, various medical device platforms – including microfluidic systems and automated sample preparation – are dependent on appropriate buffer and reagent formulations for diagnostic assay development. 

It is vital that the Canadian supply chain be less reliant on foreign players for reagent and buffers required for nucleic acid extraction. More specifically, magnetic-based buffers and formulations for SARS-CoV-2 RNA extraction and purification. While the NRC possesses the know-how and ability to fabricate COVID-19 diagnostic devices for sample-to-answer solutions, this is again hampered by the consistent shortage of reliable buffers and reagents for sample preparation and lack of on the fly configurable solution that can be integrated with microfluidic platforms. This becomes especially important for both high throughput automated systems that require a constant supply of appropriate buffers, as well as future point-of-care automated medical devices that require flexible and customizable reagents.

Maximum grant value and travel

Multiple grants could result from this Challenge.

The maximum funding available for any Phase 1 Grant resulting from this Challenge is $300,000.00 CAD for up to 3 months.

Estimated number of Phase 1 grants: 2

The maximum funding available for any Phase 2 Grant resulting from this Challenge is $1,000,000.00 CAD for up to 12 months. Only eligible businesses that have completed Phase 1 could be considered for Phase 2.

Estimated number of Phase 2 grants: 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

At the beginning of Phase 1, the kick off meeting will be held through videoconference. Phase 1 reports and demonstrations of feasibility will be done in person at Boucherville, BioAMND, Medical Devices Research Center laboratories.

Kick-off meeting

Ottawa, ON (virtual)

Progress review meeting(s)

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

Final review meeting

Boucherville (Quebec, Canada), BioAMND, Medical Devices Research Center laboratories.

All other communication can take place by telephone, videoconference, and WebEx.

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.

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