Point of Care Diagnostics to combat Antimicrobial resistance

From: Innovation, Science and Economic Development Canada

Health Canada is seeking novel, easy to use and cost-effective rapid point-of-care diagnostic and detection tool(s) that identifies and characterizes antibiotic resistant bacteria and/or distinguishes between viral and bacterial infections to address the rise of antimicrobial resistant (AMR) infections.

Sponsoring department: Health Canada

Funding mechanism: Grant

Opening date: August 23, 2019
Closing date: October 18, 2019 14:00 Eastern Daylight Time

Phase 1 award recipients

Challenge

Problem statement

Antimicrobial resistant (AMR) infections are a growing public health threat in Canada and around the world. The misuse and over use of antimicrobials in humans and animals is a major contributor to the rapid emergence and spread of AMR infections. There is a need to develop, test and commercialize novel, easy to use, and affordable real-time (point-of-care) detection and diagnostic tools that would allow human and/or animal health care providers, in a hospital, clinical or community setting, to rapidly (ideally minutes to hours) identify pathogens and their antibiotic resistance profiles in order to individually tailor treatment. One of the major barriers to the uptake and sustained use of point-of-care (POC) diagnostics to address AMR is the cost of the individual tools that makes it costly for health care practitioners to provide/use in a community setting. The innovation will fulfil an unmet need in human or veterinary medicine.

Desired outcomes and considerations

Essential outcomes

The solution must:

develop a detection or diagnostic tool(s) that would be able to accurately and reliably identify and characterize antibiotic resistant bacteria and/or distinguish between viral and bacterial infections very rapidly (within minutes to hours) at the point-of-care.
be affordable and accessible enough for implementation into standard practice at Canadian hospitals and clinics (i.e. cost of the diagnostic will have to be low enough to encourage its use rather than send someone away with a prescription for an antibiotic that is not needed).
be easy to use (e.g. requiring minimal training) and able to be maintained by health care professionals.

Additional Outcomes

The solution should:

be available for use in either human or animal health care settings;
target innovation in human health care that focusses on one or more of the pathogens on Health Canada's Pathogens of Interest list.

Background and Context

Antimicrobial resistant (AMR) infections are becoming more frequent and increasingly difficult to treat. As a result, AMR is a major threat to global public health, economic prosperity and security. The inappropriate use of antimicrobials in human and veterinary medicine, agriculture and agri-food is largely responsible for the rapid development and spread of AMR in Canada and around the world, and a coordinated One Health response from all sectors is required to tackle this problem. Antimicrobials are essential in the delivery of modern health care and it is crucial to preserve the antimicrobials currently available by preventing infections and reducing the overuse and misuse that promotes resistance. This includes the development of innovative new therapies and technologies to help prevent, diagnose and treat infections. There is currently a lack of rapid, accessible and affordable point-of-care diagnostic and detection tools in use in health care practice across Canada. One of the major barriers to the uptake and sustained use of POC diagnostics to address AMR is the cost of the individual tools that makes it costly for health care practitioners to provide/use in a community setting.

This challenge is two-fold, as the successful applicant(s) must demonstrate an ability to overcome both the scientific barriers in developing the tool and uptake barriers to successful commercialization, such as affordability (i.e. cost of the diagnostic is low enough to encourage its use rather than send someone away with a prescription for an antibiotic that is not needed) and ease of use. The Government of Canada is actively engaged in efforts to combat AMR, releasing the Federal Action Plan on AMR and AMU in Canada in 2015 and the Pan-Canadian Framework for Action in 2017.

Grounded in a One Health approach, the Pan-Canadian Framework identifies the need for action in surveillance, stewardship, infection prevention and control, and research and innovation. These pillars are heavily intertwined and this is evident in the desired outcomes of this challenge. If successful, applicants would be making significant contributions to the fight against AMR under the stewardship, infection prevention and control, and research and innovation pillars.

Maximum value and travel

Multiple grants could result from this Challenge.

Funding of up to $150,000.00 CAD for up to 6 months could be available for any Phase 1 grant resulting from this Challenge.

Funding of up to $1,000,000.00 CAD for up to 2 years 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.

This disclosure is made in good faith and does not commit Canada to award any grant for the total maximum funding value.

Travel

For Phase 1, it is anticipated that up to five meetings will require the successful bidder(s) to travel to the locations identified below:

Kick-off meeting Ottawa, Ontario
Progress Review Meetings: one to three design/progress review meetings by teleconference/videoconference
Final Review Meeting Ottawa, Ontario

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) employees^{Footnote *}
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 Canada^{Footnote *}
50% or more of its FTE employees have Canada as their ordinary place of work^{Footnote *}
50% or more of its senior executives (Vice President and above) have Canada as their principal residence^{Footnote *}

Application guide

Evaluation Criteria

Part 1: Mandatory and Minimum Pass Mark Criteria

Proposals must meet all mandatory criteria (Questions 1a and 2) and achieve the minimum pass mark for Question 3 in order to be deemed responsive and proceed to Part 2.

Mandatory and Minimum Pass Mark Criteria (Applicant/Bidder's proposal must address)
Question	Evaluation Schema
1 a. Scope Describe your proposed solution and how it responds to the challenge. Include in your description the scientific and technological basis upon which your solution is proposed and clearly identify how your solution meets all of the Essential Outcomes (if identified) in the Desired Outcomes and Considerations section in the Challenge Notice.	Mandatory — Pass/Fail Pass The Applicant/Bidder's proposed solution is clearly articulated, within the scope for the challenge and addresses all Essential Outcomes (if identified) in the Challenge Notice. Fail There is little or no evidence that the proposed solution is likely to meet the challenge. OR The proposed solution is articulated as out of scope for the challenge. OR The proposed solution does not address all Essential Outcomes listed in the challenge. OR The proposed solution is poorly described and does not permit concrete analysis.
2. Current Technology Readiness Level (TRL) Indicate the current TRL of your proposed solution. (Drop Down Menu of the Application/Bid Submission Form) Describe the research and development activities that have taken place to bring the proposed solution to the stated TRL.	Mandatory — Pass/Fail Pass: The Applicant/Bidder has demonstrated that the proposed solution is currently between TRLs 1 and 4 (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/Bidder has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 4 (inclusive) including: There is insufficient/no evidence provided for TRL judgment. The solution involves the development of basic or fundamental research. The solution is at TRL 5 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.
3. Innovation Describe the novelty of your solution and how it advances the state-of-the-art over existing technologies, including competing solutions.	Point Rated with Minimum Pass Mark The minimum pass mark for this criteria is 4 points. 0 points/Fail: The Applicant/Bidder has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR The stated advancements are described in general terms but are not substantiated with specific, measurable evidence. 4 points: The Applicant/Bidder 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. 6 points: The Applicant/Bidder 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/Bidder has demonstrated that the proposed solution offers one significant improvement to existing technologies that is likely to create competitive advantages in existing market niches 8 points: The Applicant/Bidder 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/Bidder 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 that do not achieve the overall minimum score of at least 55 points out of a possible 110 points (50%) will be declared non-responsive and given no further consideration.

The overall minimum score is determined by adding the Applicant/Bidder's scores from the following questions together (1b, 3, 4-13).

Point-Rated Criteria (Applicant/Bidder's proposal to address)
Question	Evaluation Schema
1b. Scope Describe how your proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes and Considerations 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, Bidders/Applicants will receive 10 points	Insufficient or no information provided to demonstrate that the solution will address any of the Additional Outcomes. 0 points Information provided clearly demonstrates that the solution will address some (<50%) of the Additional Outcomes. 5 points Information provided clearly demonstrates that the solution will address most (50% or more) of the Additional Outcomes. 8 points Information provided clearly demonstrates that the solution will address all (100%) of the Additional Outcomes. 10 points
4. Phase 1 Science and Technology Risks Identify potential scientific and/or technological risks to the successful development of the proof of concept and how they will be mitigated in Phase 1?	Insufficient or no information provided to demonstrate that the Applicant/Bidder has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points Information provided demonstrates that the Applicant/Bidder has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points Information provided clearly demonstrates that the Applicant/Bidder has sufficiently considered the risks and defined associated mitigation strategies. 10 points
5. Benefits to Canada Describe the benefits that could result from the successful development of your solution. Applicants/Bidders should consider the potential benefits using the following three categories: Innovation Benefits: Expected contribution towards the enhancement or development of new industrial or technological innovation within your firm. Assessment factors 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. Assessment factors could include: number of jobs created, number of high-paying jobs, project-related revenue growth, etc. Public Benefits: Expected contribution to the broader public, including inclusive business and hiring practices (e.g., gender balance), investment in skills and training and environmental best practices. Assessment would consider the degree to which the Applicant/Bidder demonstrates that the solution is expected to generate social, environmental, health, security or other benefits to Canada. Assessment factors could include: solution-related environmental benefits, investment in local communities and solution-related impact on Indigenous communities.	Innovation Benefits Benefit not identified or insufficient claim of benefit. 0 points Benefit has marginal increment or limited justification. 1.5 points Benefit is significant and well justified. 3 points Economic Benefits Benefit not identified or insufficient claim of benefit. 0 points Benefit has marginal increment or limited justification. 1.5 points Benefit is significant and well justified. 3 points Public Benefits. Benefit not identified or insufficient claim of benefit. 0 points Benefit has marginal increment or limited justification. 1.5 points Benefit is significant and well justified. 3 points
6. Phase 1 Project Plan Demonstrate a feasible Phase 1 project plan by completing the table. Include: Project milestones; project activities under each milestone; time required to complete each milestone (e.g., days, weeks and/or months); (Indicate if any milestones and activities will be completed concurrently) total time required to complete the project; and key success criteria. Note: Phase 1 cannot exceed 6 months and TRL 4.	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 Project plan for Phase 1 is conceivably feasible but not clearly demonstrated and/or includes gaps. 5 points Information provided clearly demonstrates a feasible project plan for Phase 1. 10 points
7. Phase 1 Project Risks Identify potential project risks (eg. Human resources, financial, project management, etc) to the successful development of the proof of concept and how they will be mitigated?	Insufficient or no information provided to demonstrate that the Applicant/Bidder has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points Information provided demonstrates that the Applicant/Bidder has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points Information provided clearly demonstrates that the Applicant/Bidder has sufficiently considered the risks and defined associated mitigation strategies. 10 points
8. Phase 1 Implementation Team Demonstrate how your 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. Include the labour rates and level of effort for each member. A day is defined as 7.5 hours of work, exclusive of meal breaks. The labour rates and level of effort will be reviewed as part of the evaluation for Question 10.	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 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. 5 points 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. 10 points
9. 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 bidder/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. Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response below.	No description and/or concrete examples of actions provided that would be taken to encourage greater participation of under-represented groups. 0 points A description and concrete examples of actions to encourage greater participation of under-represented groups provided. 3 points
10. Phase 1 Financial Proposal Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.	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 Information is provided but some costs appear to be either over or under estimated for the Phase 1 project plan. 5 points Information provided contains credible elements to clearly demonstrate a realistic financial proposal for the Phase 1 project plan. 10 points
11. 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.	Insufficient or no information provided to demonstrate the Applicant/Bidder's ability to manage public funds in Phase 1. 0 points Information provided is vague and/or contains gaps. The Applicant/Bidder has some controls, tracking and/or oversight in place to manage the public funds in Phase 1. 5 points Information provided clearly demonstrates that the Applicant/Bidder has strong financial controls, tracking and oversight to manage public funds in Phase 1. 10 points
12. Phase 2 Strategy Describe a realistic strategy for the prototype development if selected to participate in Phase 2. Responses should include: anticipated barriers key tasks estimated cost	Insufficient or no information provided to demonstrate that the Applicant/Bidder has contemplated a realistic strategy for the Phase 2 prototype development. 0 points Information provided demonstrates a conceivably realistic strategy for Phase 2 prototype development, however there are gaps and/or the strategy is vague. 5 points Information provided demonstrates that the Applicant/Bidder has a clear and realistic strategy. 10 points
13. Commercialization Approach Describe your overall commercialization approach for the proposed solution. 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	Insufficient or no information provided to demonstrate that the proposed solution has commercial potential. 0 points Some information provided to demonstrate that the proposed solution has commercial potential, however there are gaps in the commercialization approach. 5 points A realistic commercialization approach is provided that demonstrates that the proposed solution has commercial potential. 10 points

Questions and answers

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

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

A glossary is also available.

What processes are currently used at the point of care to distinguish between a viral infection and a bacterial one? What data do health professionals use to establish their diagnosis? Do they analyze patient scans? How much time does it take for the scanning process to take place and the analysis of the scan to be complete?

At the point-of-care assessments, health care providers use a combination of history and physical examination to generate a differential diagnosis. There are a variety of presenting symptoms and signs with examination findings that may establish if an infection is viral or bacterial in origin. Further work up with laboratory tests and medical imaging assist to confirm or rule out possible alternative diagnoses and establish the diagnosis when further confirmatory data are necessary. This further work up is not performed at the point of care.

Examples of currently available point-of-care tests that a clinician may use to assess for a bacterial and viral pathogen include rapid strep testing and oropharyngeal viral swabs for PCR respectively, both of which have same day turnaround time in the hospital laboratory setting but may not be available at the bedside nor in a community office setting. An example of an imaging test that could be considered 'point-of-care' would include portable chest radiographs taken in an emergent setting to assess for pneumonia.

If the challenge is accepted, will the help of AMR specialists be provided or will we need to seek out our own specialists?

It is expected that the developer of the device would find or consult AMR specialists on their own, as needed.

To find a real-time solution, it is important to have access to data of patients with AMR. How will this aspect of the issue be resolved? Will there be a partnership between the Department and the selected companies?

The Public Health Agency of Canada, under the Canadian Antimicrobial Resistance Surveillance System (CARSS), publishes annual reports, available online, on AMR priority organisms, antimicrobial use and other surveillance data that could be useful to understand the current landscape of AMR in Canada. Health Canada would not be a partner with the manufacturer or organizations developing the solution to the challenge.

Is the goal of this challenge to detect antibiotic-resistant bacteria or to classify infections as viral or bacterial at the point of care? Is there a correlation between antibiotic resistance and viral or bacterial infections?

Quick, affordable, reliable, and easy-to-use methods to differentiate between viral and bacterial infections and/or to identify resistance mechanisms are needed to curb the rise of antimicrobial resistance. Antimicrobial resistance occurs when pathogens (such as bacteria) develop the ability to defeat the drugs (such as antibiotics) that are designed to kill them or stop them from multiplying. Antibiotic resistance can happen naturally, but a major contributor is the overuse and uniformed use of antibiotics in both humans and animals. For example, antibiotics are not effective to treat viral infections but may still be prescribed if the cause of an infection is uncertain. Therefore, it is important for the health care provider to have appropriate tools to assist in differentiating between viral and bacterial infections when necessary to determine the appropriate treatment option.

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