Notice

Point of Care Diagnostics at the Front Line Phase 2: Frequently Asked Questions

Updated 31 August 2022

1. Questions from Launch Event Q&A dial in 3 August 2022

1.1 General Questions

Q: What Terms and Conditions are applicable to this Themed Competition?

A: Please see Terms and Schedules which are the Terms and Conditions applicable to this competition.

Q: Who will own the Intellectual Property (IP) after contracts have completed?

A: The Contractor will own the IP in accordance with DEFCON 705.

Q: DEFCON T&Cs require suppliers to report details to allow the technology to be replicated. How does that statement align with ownership of the IP by the contractor?

A: DEFCON 705 will be applicable to this competition. Under the terms of DEFCON 705 any intellectual property generated under the contract belongs to the contractor. In return, the funding Authority obtains a set of rights to use the delivered technical information and associated intellectual property for specified purposes. More information on DEFCON 705 can be found here

Q: Our company was not involved in the Phase 1 of this competition ‘Point of Care Diagnostics at the Front Line’. Can we apply for the Phase 2?

A: Yes, bids will be assessed based on what is provided in the proposal, not on what has previously been funded from the phase 1 contracts.

Q: What is the lowest Technology Readiness Level (TRL) considered acceptable? What is the lowest TRL to be achieved on successful completion of the project?

A: There is no lower limit for the starting TRL of the proposed innovation. However, the funded projects must complete their contract at TRL 5.

Q: Are consortium bids allowed or preferred?

A: Collaborative bids are encouraged, but there is no preference. For collaborative bids, one entity takes the lead as primary applicant and the others are treated as contractors.

Q: Can a project costing more than £500k be part-funded internally if DASA funded two projects?

A: The competition document states ‘we expect to fund two proposals of up to £500k (Exc. VAT) each in value. However, DASA reserves the right to fund one outstanding bid up to £1M (Exc. VAT).’

Q: What would you expect to see in a £1M proposal?

A: For a £1M bid, we would expect to see a further amount of developmental progress made against the competition challenge in comparison to a £500K proposal, i.e. in relation to levels of specificity, sensitivity, portability etc. This would be together with detailed evidence of project planning to provide assurance that the proposal goals can be achieved within the contract duration. Other examples of what we would be looking for from a £1M proposal in comparison to a £500k proposal are, but not limited to:

• more details of the risks, tolerances and mitigations

• showing that a highly skilled team are in place to work on the contract from the kick-off

• mitigations of risk from team member absences

• provision of -in-depth performance data

• evidence of previous history of delivery against large amounts of funding in a relatively short space of time

Q: For a themed call do we need or is it advantageous to have an MOD sponsor / customer?

A: For a themed competition it is not essential to have an exploitation route lined up, but if you have an idea it would be helpful to include this in the proposal.

Q: Where can I see the projects funded in Phase 1?

A: All the projects funded by DASA can be found on our website under transparency data. All the projects funded by DASA in Point of Care Diagnostics at the Front Line Phase 1, can be found here.

Q: Would any GFA be provided as part of the project, e.g. antigens?

A: No, Government Furnished Assets (GFA) will not be provided.

1.2 Scope Questions

Q: Who do you foresee as the end user? Is it a field hospital / lab- does the solution need to ruggedized?

A: The end user will be a military biomedical scientist or a military clinician. It would be used as near to the patient at possible, which could be a field hospital or on the front line. Ideally we would like platforms to be ruggedized by the very end of their development. If the technology is not at that point yet, we would like to see consideration as to how it might become ruggedized with further development; either as a deliverable during this contract or as a future developmental route recommendation.

Q: Are there any exploitation routes after the competition contracts end?

A: There are exploitation pathways within Dstl for technologies to reach higher TRLs. However, at present, there cannot be any commitment from Dstl to take projects forward for progression past the contract end at TRL 5.

Q: Is this point-of-care to detect pathogens in a person’s body, or to assess / measure impact to the body caused by a pathogen or another toxic agent?

A: It could be either. We are not looking for standard clinical chemistry devices, but are looking at host biomarkers that could determine the presence of an infectious agent within the body.

Q: Do you want the capability to be able to detect other disease markers and markers for stress etc; a platform solution?

A: If there is a pan target platform, yes we would like to know about that. The use case is that someone is symptomatic and a biomedical scientist or clinician wants to find out what is wrong. So the presence of a biological / chemical agent is great. A marker / prediction that the person will be ill is helpful. POC platform is very useful. Specific targets are also helpful.

Q: How do you see chemical weapon agents (CWAs) fitting in to this call? You have stated that you need two pathogens.

A: Whilst the majority of threat-based diagnostic challenges are likely to be from infectious agents, there is some scope within this call for testing and validation of diagnostic technologies against chemical agents. It is envisaged that diagnosis of chemical weapon agent (CWA) exposure will most likely involve identification and measurement of host biomarkers. Consequently, proposals seeking to test their device through chemical agent exposure routes should focus on a host biomarker whose expression is commonly affected by exposure to two (as a minimum) separate known CWAs. Due to the difficulties of working with CWAs, technology performance should be demonstrated by the use of two simulant CWAs (which would be agreed between the supplier and Dstl technical partner at the beginning of the project). Technologies that would require prior identification of a baseline ‘normal’ host biomarker level in all individuals prior to deployment are out of scope for this call.

Q: What are the size / weight limits of an acceptable instrument?

A: There is not a definite cut-off; a device that can be used as close to the patient as possible is desired but there are not strict measurement or weight specifications in this phase 2 competition. If the technology is not at that point yet, we would like to see consideration as to how it might become more portable / smaller / lighter with further development; either as a deliverable during this contract or as a future developmental route recommendation.

Q: Would clinical samples sourced from an approved supplier be acceptable to determine diagnostics sensitivity specificity or do you just want analytical?

A: Ideally we would just like analytical. That’s not to say you couldn’t obtain the samples from a well-regarded supplier, this should be included in your proposal.

Q: Will DASA / Dstl provide information on specific or generic targets on which to base the project, and demonstrate the sensitivity levels?

A: This is mentioned in the competition document, where suppliers are referred to the HSE approved list of biological agents.

Q: Are you interested in testing of clinical samples? Or more focused on technical advances of the platform itself?

A: We want both, as stated in the competition document. A technology can be advanced through the project and used to test for clinical samples and do both in the timeframe.

Q: Does the technology or test need to detect and identify bacterial, fungal and viral pathogens?

A: Ideally, that would be great, but bacterial and viral is the baseline.

Q: Are you interested in the assessment of the prognosis on the pre-symptomatic stage of an infectious disease or chemical intoxication?

A: Yes, we are interested in any project that can give as much information as quickly as possible after an exposure or infectious event.

Q: Are you interested in the assessment of the severity and prognosis of the infection disease or chemical intoxication?

A: Yes, if, for example, this is referring to quantifying the levels of infectious agent within a sample. We aren’t specifically asking for this, but if it could be reliably generated by any proposed technology then that would be looked upon favourably. However, this is not a defined requirement at this stage.

Q: Would miniaturisation of existing technologies fit within the scope?

A: Yes, in principal this would be in scope.

Q: Is there a specific bacterial / viral panel the MOD is looking for that we should design to in the first instance?

A: No. The infection models used should be common pathogens that can be handled up to the Advisory Committee on Dangerous Pathogens (ACDP) category 2.

Q: Is there a specific sample type which is preferred?

A: No. However, samples should be in a relevant clinical matrix; blood, urine, saliva and Cerebrospinal Fluid (CSF) are all acceptable.

Q: The call requires technology validation in a relevant environment. Is there a preferred setting where the MOD would like to see this validated?

A: As specified in the competition document, in this context, the ‘relevant environment’ relates to the MoD endorsed TRL 5: ‘Basic Technology Validation in a Relevant Environment’. Our interpretation of this, for the purposes of this clinical diagnostic call, is:

• defined performance in terms of sensitivity and specificity for both a bacterial and viral agent within a relevant clinical matrix

• demonstrable potential for use outside of a lab environment

• use of the technology without managed environmental conditions

• samples should be processed with minimal operative intervention and without dilution of sample

2. Clarification Questions from 9 August 2022

2.1 General Questions

Q: Is there a minimum number of years the company needs to have been trading for, or a minimum size of company required in order to apply?

A: DASA has no requirement as to the length of time a company has been established for that company to bid in to a competition. There are also no requirements in relation to the size of the company. DASA competitions are open to all.

Q: When we apply online, should we use an agent or can we see what the format looks like? Is there a template?

A: DASA has regional Innovation Partners that can provide guidance on the submission process. DASA does not provide a template of the submission form. However, after registering for an account you can launch an application and save your progress to come back to later. You are able to view the questions on the application at this point. It is also possible to copy the questions from the submission form to complete offline. Just make sure all boxes on the submission form are completed before submitting.

Q: Would proposals that are bidding for less that £500k, with contracts of less than 12 months be accepted?

A: The competition states that we are looking for bids up to £500k and of up to c.14 months in duration, with the expectation for all contracts to start early January 2023 at the latest and completing by 28 February 2024 at the latest. If a proposal has bid for less than this amount or is proposing to do the contracted work in less time, this would be acceptable.

Q: How much detailed is required in each proposal?

A: You should ensure that all questions in the application form are answered in detail. There should be enough technical detail to understand what the proposed technology is and the prior performance of the proposed technology. There should also be a detailed project plan to provide assurance that your goals can be completed in the contract duration. However, please be advised that assessors are allocated 90 minutes to assess your proposal, so your proposal should be concise.

Q: Can a proposal include different options for the proposed work?

A: No, your proposal should contain the work you plan to carry out and will form the basis of your contractual agreement should it be selected for funding.

2.2 Scope Questions

Q: Is testing with potential patient samples desired or required?

A: It is not required. However, if used, the inclusion of detailed analytic sensitivity and relevant units of measurement would be required. If MODREC approval is needed for the use of patient samples, due to time constraints, this would not be in scope for this phase of competition. A link to MODREC guidance can be found in the competition document.

Q: Are bacterial and viral the only 2 pathogens that should be considered or can fungal be considered also?

A: Bacterial and viral are the minimum, but if you would like to include more that is acceptable.

3. Questions from 17 August 2022

3.1 General Questions

Q: Is recruitment time included in the project duration?

A: The project can be up to 14 months in duration, with the expectation for all contracts to start early January 2023 at the latest and completing by 28 February 2024 at the latest. If recruitment is likely to be difficult within this timeframe and there is a risk that it could delay the project, this should be identified as a risk and clear mitigation steps provided. NB Proposal deliverables will be contracted and the supplier will need to achieve them in order to receive payment. Recruitment plans and mitigations will need to consider this.

Q: Would we be able to get input from end users?

A: If successful, you would be assigned a technical partner (TP) who, together with the Dstl project team, would provide the supplier with an understanding of the Defence and Security context.

Q: Does every aspect of the innovation need to be at TRL 5; for example what if only one sample type was developed to TRL 5?

A: If only one sample type reaches TRL 5 that is acceptable as long as you can detect the two agent types specified. You need to supply evidence of prior performance in a clinical matrix. TRL 5 is not an end platform, what you need to do is show the technology has clear potential to ultimately be deployed in the austere environments associated with frontline medical care.

Q: Can a supplier submit a proposal for a project that will reach higher than TRL 5?

A: The competition document states that Phase 2 will be looking for proposals that can further develop appropriate diagnostic technologies to TRL 5. This is the maximum TRL that this project requires..

3.2 Scope Questions

Q: Is a benchtop or portable device what you’re looking for?

A: The competition document states that we are interested in devices that can be used as close to the patient as possible, which means degrees of portability are desired. This competition is for technologies up to TRL 5, so while the deliverables will not necessarily be ‘field ready’ there needs to be a clear route to getting to that point.

Q: What biomarkers should we be looking at; are there any primary reference biomarkers to use?

A: For exposure to chemical weapon nerve agents the primary biomarkers would be acetylcholinesterase and butyrylcholinesterase. Many nerve agents kill the activity of these enzymes.

Q: What type of sampling are you interested in, e.g. swab testing of clothes, salvia testing or blood testing?

A: That is your choice, but ensure it is a relevant clinical matrix taken from an individual.

Q: Would immunoassay methods be an appropriate solution for biological agents?

A: Yes, the technology is your choice.

Q: Would it be attractive to be able to detect chemical and biological agents?

A: In this competition we are looking for technological development of a detection method for either chemical or biological agent exposure rather than both. However, a technology that could ultimately detect chemical and biological agent exposure would be acceptable.

Q: What is the relevant environment for TRL 5?

A: The TRL definitions are taken from a broad MOD TRL document. For this competition the relevant environment is the clinical matrices and biological agents requested in the competition document; it is taken to mean clinical sample type (i.e. ‘this technology works when analysing such a matrix’). Please refer to the competition document for our TRL 5 scope.

Q: Is toilet waste a relevant clinical matrix?

A: No. Relevant clinical matrices include blood, urine, saliva and other matrices commonly used for the diagnosis of infectious disease in an individual.

Q: Does the one hour detection time in the competition document include the time taken to collect the sample?

A: No. The c. one hour detection time starts when the sample is placed on the device, so it doesn’t include collection.