Marine Biotoxin Detection Devices for Shellfish

January 28, 2019 Attachment 1 has been added. The document contains questions and answers related to the Challenge. ***************** This Challenge Notice is issued under the Innovative Solutions Canada Program Call for Proposals 002 (EN578-170003/C). Please refer to the Solicitation Documents which contain the process for submitting a proposal. Steps to apply: Step 1: read this challenge Step 2: read the Call for Proposals Step 3: propose your solution Challenge title: Marine Biotoxin Detection Devices for Shellfish Sponsoring Department: Canadian Food Inspection Agency Funding Mechanism: Contract MAXIMUM CONTRACT VALUE: Multiple contracts could result from this Challenge. The maximum funding available for any Phase 1 Contract resulting from this Challenge is $100,000.00 CAD (plus tax) including shipping, travel and living expenses, as applicable, for up to 6 months. The maximum funding available for any Phase 2 Contract resulting from this Challenge is $300,000.00 CAD (plus tax) including shipping, travel and living expenses, as applicable, for up to 2 years. Only eligible businesses that have completed Phase 1 could be considered for Phase 2. This disclosure is made in good faith and does not commit Canada to contract for the total approximate funding. TRAVEL:  For Phase 1 it is anticipated that two meetings will require the successful bidder(s) to travel to the location identified below: Kick-off meeting Burnaby, British Columbia Final Review Meeting Burnaby, British Columbia Problem Summary Statement The Canadian Food Inspection Agency (CFIA) is seeking to develop innovative devices for detecting marine biotoxins encountered in Canadian waters with increasing frequency. Problem Statement The CFIA’s responsibilities under the Canadian Shellfish Sanitation Program (CSSP) include maintaining a biotoxin surveillance program for shellfish growing areas, with monitoring for paralytic shellfish poisoning (PSP) toxin being a key deliverable of the biotoxin program’s food safety objectives. Marine biotoxin test kits exist but have a number of critical limitations (e.g., detection of a broad range of toxins in multiple matrices, sensitivity, specificity, ease of use in the field, etc.). Additionally, testing must be done in a laboratory which is impractical for remote communities, including many Indigenous communities. Having an inexpensive but effective device/test kit that could be easily used and interpreted by lay people would provide many benefits. For example, if an individual harvesting shellfish in a remote community detected marine biotoxins they could then delay the harvest or choose not to sell their catch, avoiding distribution and consumption of dangerous product in their family and community. The challenge is to identify and develop innovative solutions and devices for the detection of paralytic shellfish toxins found in Canadian shellfish harvest areas. This could include devices or tests that use antibodies and colour change to identify the toxins; techniques could include enzyme-linked immunosorbent assay (ELISAs) and lateral flow assays (LFAs), or instrumentation that identifies toxin profiles or critical components. Desired Outcomes and Considerations Essential (Mandatory) Outcomes Proposed solutions must:

have the ability to detect all relevant toxins (GTX4, GTX1, dcGTX3, GTX5, dcGTX2, GTX3, GTX2, NEO, dcSTX, STX, C-1, C-2) have detection limits (<40 µg/100g) have cross-reactivity between toxins GTX1, GTX2, GTX3, GTX4, and NEO that matches the potency of the toxin have minimal probability of false positives and false negatives (<5%) have robust temperature conditions for storage (4°-30°C) have the ability to meet the above criteria in shellfish tissue and/or geoduck clam (gut ball) matrices. Single or multiple devices may resolve individual matrices, or any combination of the above. be sufficiently robust to withstand the elements and perform under field conditions not be cost prohibitive for the intended end users.

Additional Outcomes Proposed solutions should: emphasize ease of result interpretation and ease of use for field/public. Ability to test multiple matrices should also be emphasized. Background and Context PSP toxins are a group of closely related tetrahydropurine compounds with varying levels of toxicity. Eighteen to 24 known toxins are attributed to the parent compound and its derivatives. The Canadian PSP action level is a cumulative toxin level set at 80 micrograms per 100 g of meat; allowing for varying levels of different toxins in the group to be present up to the maximum. As part of the CSSP long term sustainability initiative, CSSP partners are currently exploring alternative service delivery options for CSSP activities including the adoption of marine biotoxin rapid test kits. The CFIA, Environment and Climate Change Canada and the Department of Fisheries and Oceans are responsible for the CSSP. At present, the only existing option for biotoxin testing in Canada is to send samples to a CFIA laboratory. The industry and remote communities require alternative testing methods for the determination of PSP toxins. The evolution of rapid test kits makes them increasingly applicable, especially in remote regions where samples would not be able to reach the testing labs in a reasonable amount of time. Current commercial rapid test kits suffer from a combination of poor cross-reactivity between primary toxins, high prevalence of false positives and high detection limits. These drawbacks prohibit their use for an alternative service delivery and none of the current commercial products fit the CFIA’s need. More specifically, weaknesses include: • Does not detect all regulated toxins • Poor cross reactivity to GTX1,4 and NEO and GTX2,3 • High risk of false positives • High risk of false negatives • High temperature range: 18-30°C.  A kit that only works at relatively high temperatures and under highly climate controlled conditions would not be suitable for rudimentary labs or any field use in the northern hemisphere. Robust kits must function under temperature conditions broad enough and low enough to support a variety of testing environments. • Poor sensitivity to geoduck gut ball matrix • Relevance to the CFIA Different countries monitor different toxins. Kits currently in use in other jurisdictions do not monitor for all toxins identified as being regulated and relevant in Canada. ENQUIRIES All enquiries must be submitted in writing to TPSGC.SIC-ISC.PWGSC@tpsgc-pwgsc.gc.ca no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.