Detection of food borne pathogenic bacteria using field deployable instruments

From: Innovation, Science and Economic Development Canada

The use of field-deployable devices that can reduce risk in the production of safe and sustainable foods by detecting food borne pathogens in several aspects of farm-to-fork continuum.

Challenge sponsor: Canadian Food Inspection Agency (CFIA)

Funding mechanism: Grant

Opening date: June 25, 2020
Closing date: July 28, 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

The CFIA is mandated to protect the health of Canadians by safeguarding food safety in the farm-to-fork continuum, including the protection of animal and plant health. While the CFIA is the regulatory body that enforces acts and regulations aimed at reducing the risks of food borne diseases, the food producers and processors are ultimately responsible for the safety of their products. Canadian producers employ the latest food safety programs and technologies available in reducing the risks or food borne pathogens; however, contaminated food continues to reach the Canadian public despite all the efforts by industry and the CFIA. This results in a number of recalls and outbreaks that cost the health care system and producers millions of dollars each year. Further, the Government of Canada estimates that there are about 4 million cases of foodborne illness in Canada every year, leading to 11,500 hospitalizations and 240 deaths.

To evaluate the safety of food products analysts are required to conduct extensive testing that often take days to obtain a final test result. Having field deployable, rapid, sensitive, and specific testing methodologies would enable industry stakeholders to better protect Canadians, provide a safe food supply, and meet international standards for exports. With such devices, the food industry can increase the number of pathogen tests and can better prevent the presence of contaminated products from reaching the market place.

Essential (mandatory) outcomes

The solution must:

  1. Detect food borne pathogenic bacteria from samples taken from food production and processing facilities, as well as food products that require minimal processing such as leafy greens, fruits, and vegetables.
  2. Develop a robust field-deployable diagnostic tool that would be deployable in processing and production settings without the need for supporting equipment (i.e. incubators, centrifuges) and a fully functional laboratory with a minimum training.
  3. Detect at a minimum of one of the following bacteria: Salmonella sp., Listeria monocytogenes and Verotoxigenic E. coli including O157:H7 in leafy greens such as lettuce or spinach.
  4. Be commercially available (available for sale in Canada) for implementation into production and processing environments for use by industry including food producers/processors and farmers.
  5. Be validated in accordance to validation criteria outlined in the Canadian Compendium of Analytical Methods CAM (Volume 1, Part 4) and must meet all performance parameters outlined in the validation protocol. In summary, the following parameters must be met as outlined in Part 4:
    1. Inclusivity and exclusivity studies
    2. Sensitivity ≥98%
    3. Specificity ≥90.4%
    4. False negative rate <2%
    5. False positive rate ≤9.6%
    6. Efficacy ≥94%
    7. Level of detection of the alternative method must be comparable to or exceed the lower limit of detection of the reference method
  6. Have robust temperature conditions for storage (4° and 30°C)
  7. Require minimum sample preparation or sample preparation that can be performed "in field" during the testing period.

Note to applicants. The following Essential (Mandatory) Outcome has been amended and moved to the Additional Outcomes section: Not be cost prohibitive for the intended end users. Instrumentation should be below $20,000 and the test kit should be below $35 Canadian dollars.

Additional outcomes

The solution should:

  1. Target multiple food borne pathogens from the above list in leafy greens.
  2. The following section has been added as a new requirement.Not be cost prohibitive for the intended end users. Instrumentation should be below $20,000 and the test kit should be below $35 Canadian dollars.End of section.

Background and context

Current food pathogen testing programs can be time and resource-consuming, requiring significant investments in capital and human resources. While Canada employs cutting edge testing methodologies through significant research and development, the use of field deployable systems can significantly reduce the time and resources that are needed to detect hazards. For example, the industry and remote communities require alternative testing methods to analyze biological hazards in food with a short shelf-life as part of their preventive control. By detecting hazards early on during the food production and processing continuum, it is possible to prevent the distribution of contaminated products, reducing the need to remove them through the recall process.

Food testing is a cornerstone of any Hazard Analysis and Critical Control Point (HACCP) program aiming to reduce the potential for contaminating foods in the marketplace with a food borne pathogen. By developing a fit-for-purpose handheld or field deployable device that can detect food borne pathogens, the food safety system can be constantly evaluated and adjusted to decrease the overall pathogen load. The device must be able to detect pathogens at a level equivalent to the standard cultural methods employed by the CFIA laboratories determined through a rigorous method validation as outlined in Canadian microbiological standards.

Additionally, the need for these types of tools and their development has been identified as a key priority for the Government of Canada and the Minister of Agriculture through the recently published mandate letter. The mandate letter states:

"Support the Minister of Small Business, Export Promotion and International Trade in identifying additional tools to help Canada's agricultural and agri-food businesses export their products and diversify into global markets."

By developing such detection tools, industry can better and more rapidly detect microbial hazards to meet international requirements for export in addition to domestic food safety regulations.

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 $150,000.00 CAD for up to 6 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 18 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

It is anticipated that two meetings may require the successful bidder(s) to travel to the location identified below:

Kick-off meeting

Ottawa, Ontario

Progress review meeting(s)

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

Final review meeting

Ottawa, Ontario

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.

Develop a robust field-deployable diagnostic tool that would be deployable in processing and production settings without the need for supporting equipment (i.e. incubators, centrifuges) and a fully functional laboratory with a minimum training.
– Does this mean that the solution must not have any supporting equipment or rely on a function lab. Or does it mean the solution can rely on a functional lab but with minimal training?

The successful solution may have supporting equipment that must also be field deployable; however, the solution must be stand alone and work without a functional on site or offsite laboratory.

Detect at a minimum of one of the following bacteria: Salmonella sp., Listeria monocytogenes and Verotoxigenic E. coli including O157:H7 in leafy greens such as lettuce or spinach
– Does this mean that the O157:H7 serotype must be included if verotoxigenic E.coli is chosen?

The test can target various or several bacteria; however, if Verotoxigenic E. coli serotypes is selected,  the test must include the O157:H7 serotype as a target.

Be validated in accordance to validation criteria outlined in the Canadian Compendium of Analytical Methods CAM (Volume 1, Part 4) and must meet all performance parameters outlined in the validation protocol
– To clarify, at the end of the phase I project, the solution must meet these criteria?

Any proposal that is put forward must demonstrate a clear validation plan on how the device and the test kit will be validated in accordance to the Canadian standard and must meet all of the Essential Outcomes by the end of Phase 2.

One of the objectives of the challenge, is to rapidly detect microbial hazards. However, there is no definition of what "rapidly" means. Is there any throughput requirement for this challenge? For example, is there a requirement for a single instrument to process X amount of samples in Y amount of time?

In the context of a hand held or a field deployable device, the results should be available in a 3 to 5 hour time frame from sampling; however, the Canadian Food Inspection Agency will consider the scientific merit of proposals that do not meet this exact timeframe or have a longer turnaround time during the evaluation process.

Regarding the "Detection of food borne pathogenic bacteria using field deployable instruments" challenge, we were wondering what the scope/range of affordability is? I.e. is $10,000-$50,000 considered affordable or even $100,000?

Instrumentation should be below $20,000 and the test kit should be below $35 Canadian dollars.

It is stated that the test kit should be below 35 Canadian dollars, but the acceptable outcomes state that the solution must detect at least one of three bacterial species. Does the limit of $35 apply the same way for detection of only one, two or three pathogens? I mean, is it $35 for each pathogen or $35 for kit independently of the number of pathogens detected?

The value in the current challenge is for a single pathogen detection system. While it is expected that a test kit targeting more pathogens may exceed this value, at this time the cost of multi-target kits are not specified. Currently there are limited test kits that target multiple pathogens and as such there is less information available to accurately estimate the costs of multi-target test kits.

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