Notice

Point of Care Diagnostics at the Front Line Phase 2: Competition Document

Updated 31 August 2022

1. Introduction

This Defence and Security Accelerator (DASA) competition seeks proposals for novel and innovative ‘Point of Care’ (PoC) diagnostic technologies that provide information to enable clinicians to diagnose and treat individuals earlier and more effectively following exposure to biological or chemical agents. Phase 2 will look for proposals that can demonstrate low-burden diagnostic technologies applicable to Role 1 Medical Treatment Facilities or lower, with innovators developing their technology to Technology Readiness Level 5 TRL, namely ‘Technology basic validation in a relevant environment’.

This competition is funded by Defence Science and Technology Laboratory (Dstl).

2. Competition key information

Submission deadline

Midday (BST) on 22nd September 2022.

Where do I submit my proposal?

Via the DASA Online Submission Service for which you will require an account. Only proposals submitted through the DASA Online Submission Service will be accepted.

Total funding available

£1M (Exc. VAT) funding is available and 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) that demonstrates value for money, provides high quality supporting evidence of platform performance to date as well as a detailed project plan to deliver on the competition challenges. Contracts will be awarded for a duration of up to 14 months from 03 January 2023 and must complete by 28 February 2024 (although proposals of shorter duration will also be accepted).

3. Supporting events

Dial-in sessions

3rd August 2022 – A dial-in session providing further detail on the problem space and a chance to ask questions in an open forum. If you would like to participate, please register on the Eventbrite page. To get the most out of this session, we strongly advise that you attend with a good knowledge of the competition document.

9th August 2022 – A series of 15 minute one-to-one teleconference sessions, giving you the opportunity to ask specific questions. If you would like to participate, please register on the Eventbrite page. Booking is on a first come first served basis.

17th August 2022 – A series of 15 minute one-to-one teleconference sessions, giving you the opportunity to ask specific questions. If you would like to participate, please register on the Eventbrite page. Booking is on a first come first served basis.

6th September 2022 - A series of 15 minute one-to-one teleconference sessions, giving you the opportunity to ask specific questions. If you would like to participate, please register on the Eventbrite page. Booking is on a first come first served basis.

4. Competition Scope

4.1 Background

Disease caused by exposure to biological or chemical agents, represents a key issue for deployed personnel. Throughout the history of armed conflict, disease (regardless of source) has been a significant cause of morbidity and mortality among British forces that has led to reductions in the operational effectiveness of fighting elements. This issue remains current. The effective management and treatment of affected personnel remains a key challenge for the future where personnel may be deployed to parts of the world where endemic and emerging disease may be prevalent or subjected to the deliberate release of biological warfare (BW) or chemical warfare (CW) agents.

Technologies that enable rapid diagnosis of individuals exposed to biological or chemical agents are currently limited. They are also time-consuming, resource intensive, provide a limited identification capability and frequently rely on reaching back to laboratory facilities to achieve a higher confidence output.

This challenge seeks to address this issue through the development of novel, enhanced PoC diagnostic devices which provide a result in a short time (c. 1 hour) and that can be used as close to the patient as possible (including in austere locations). Such devices will support clinicians to make informed, high confidence, diagnoses that optimise the management of affected individuals.

A phase 1 PoC competition was launched in July 2019 through DASA to find technologies that would enable the diagnosis of individuals exposed to a wide variety of agents. Following a Decision Conference in October 2019, eight innovators applications, from both industry and academic institutions, were selected for Phase 1. From December 2019, the innovators worked with Dstl to develop diagnostic technologies through the initial TRLs.

Phase 2 will be looking for proposals that can further develop appropriate diagnostic technologies to TRL5, ‘Technology basic validation in a relevant environment’ DASA TRL Guide, ahead of potential development through MOD exploitation routes and full scale clinical evaluation. Proposals are invited both from innovators who received Phase 1 funding and also from innovators with novel technologies applicable to the competition aims who have not previously been funded.

4.2 Scope

At present, there is a limited diagnostic capability within overseas theatres of military operations. Complicated multiplex technologies, capable of detailed analysis of patient samples, are generally found at locations where infrastructure is good (i.e. Medical Treatment Facility Role 3) and where sufficient expertise is situated to analyse and interpret complex data outputs. Simpler technologies may be found closer to the frontline; however, while they may work in demanding austere environments, their output is limited in terms of sensitivity or specificity, as well as the diversity of potential targets they can detect.

We are interested in low TRL technologies (TRL2-4) that would enable the diagnosis of individuals exposed to a wide variety of agents at PoC.

Innovators need to include development of assays to a clinically relevant bacterial and viral CL2 pathogens HSE ‘The Approved List of biological agents. Innovators’ proposals must include a detailed project plan which demonstrates that they can reach TRL 5 within the project duration. For TRL 5, the successful innovators will have validated the technology in a relevant environment; for this competition the term ‘relevant environment’ has the following scope:

• Defined performance in terms of analytical 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.

Our ultimate goal is to provide simple-to-use PoC diagnostic devices that are capable of complex outputs to aid decision making for treatment.

5. Competition Challenge

This competition has one challenge.

5.1 Challenge 1

It is anticipated that new PoC diagnostic devices applicable for this call will support one or more of the following requirements:

• Minimal or no requirement for manual sample preparation steps for different complex clinical samples; (blood, serum, plasma, saliva etc).

• Provide a rapid (c.1 hour or less) time to answer, to facilitate delivery of timely information to clinicians to inform treatment options.

• Provide high confidence information outputs with a minimal level of false positives and negatives; i.e. high levels of specificity and sensitivity for detection of analytes of interest from complex clinical samples.

• Flexible and adaptable to integration of new assays for additional analytes to facilitate identification of a broad spectrum of agents.

• Technologies that show consideration for development / deployment against the Defence Lines of Development (DLOD); the DLODs provide a mechanism for co-ordinating the parallel development of different aspects of capability that need to be brought together to create a real military capability namely: Training, Equipment, Personnel, Information, Concepts & Doctrine, Organisation, Infrastructure and Logistics (i.e. Sustainability).

• Proposals should detail exploitation routes for devices, specifically how their technology could be produced on a larger scale.

• Performance platform should be assessed against a minimum of two pathogens (to include both bacterial and viral).

We expect there to be a clear application of the technology to a defence and security context. However, it is anticipated that successful platforms would be exploited in both the military and clinical sectors with applications in deployed environments, as well as primary and secondary healthcare settings .

Analytical sensitivity should be determined as Limit of Detections (LODs) for each agent being tested, within a relevant clinical matrix. For the purposes of this competition LODs is defined as the lowest concentration of an analyte in a sample that can be consistently detected with a stated probability (95% certainty). The following units of measurements: cfu / ml or pfu / ml will be used. Generated values should be used to compare against the LODs of established laboratory technologies.

Specificity should be determined against appropriate inclusivity and exclusivity panels for each agent being tested. The exact composition of these panels can be agreed with Dstl Technical Partners during the course of the project.

For Phase 2, in line with the requirements listed above, DASA is seeking proposals that demonstrate feasibility of novel devices for detection of low levels of analyte in complex sample types. Applicants are directed to focus on the development of novel concepts that have the capability of overcoming the logistical and user burden associated with existing technologies. Furthermore, proposers should provide a clear description of how methodologies developed are appropriate for, or could be adapted to, the constraints of a low resource setting.

6. Clarification of what we want:

6.1 We are interested in…

We want novel ideas to benefit end-users working in UK Defence and Security. Your proposal should include evidence of:

• prior technology performance data

• consideration of eventual scalability and translation

• a clear statement of the benefit posed by the proposed approach over existing technology

• theoretical development, method of advancement or proof of concept research that demonstrates potential for translation to practical demonstration in later phases

• innovation or a creative approach

• clear demonstration of how the proposed work applies to any defence and security context

6.2 We are not interested in…

We are not interested in proposals that:

• constitute consultancy, paper-based studies or literature reviews which just summarise the existing literature without any view of future innovation

• are an unsolicited resubmission of a previous DASA bid

• offer demonstrations of off-the-shelf products requiring no experimental development (unless applied in a novel way to the challenge)

• offer no real long-term prospect of integration into defence and security capabilities

• offer no real prospect of out-competing existing technological solutions

• involve the use of ‘Wearable’ diagnostic technologies, i.e. worn by the individual and which continuously monitor host physiological responses (if you have a ‘Wearable’ Technology you wish to propose, please see DASA competition ‘Generation-after-next Wearable Technologies’ which closes Midday (BST) on 25 August 2022; alternatively you may wish to discuss this with a DASA Innovation Partner. See how to get in touch here)

• would require the undertaking of clinical trials that would require ethical approval

7. Accelerating and commercially exploiting your innovation

It is important that over the lifetime of DASA competitions, ideas are matured and accelerated towards appropriate end-users to enhance capability. How long this takes will depend on the nature and starting point of the innovation.

7.1 A clear route for commercial exploitation

For DASA to consider routes for commercial exploitation, ensure your deliverables are designed with the aim of making it as easy as possible for collaborators/stakeholders to identify the innovative elements of your proposal.

Whilst early identification and engagement with potential end users during the competition and subsequent phases are essential to implementing an exploitation plan, during the competition phase there should be no correspondence between innovators and DASA other than via the Accelerator email or Commercial team.

All proposals to DASA should articulate the expected development in technology maturity of the potential solution over the lifetime of the contract and how this relates to improved operational capability against the current known (or presumed) baseline.

7.2 How to outline your exploitation plan

A higher technology maturity is expected in subsequent phases. Include the following information to help the assessors understand your exploitation plans to date:

• the intended defence or security users of your final product and whether you have previously engaged with them, their procurement arm or their research and development arm
• awareness of, and alignment to, any existing end user procurement programmes
• the anticipated benefits (for example, in cost, time, improved capability) that your solution will provide to the user
• whether it is likely to be a standalone product or integrated with other technologies or platforms
• expected additional work required beyond the end of the contract to develop an operationally deployable commercial product (for example, “scaling up” for manufacture, cyber security, integration with existing technologies, environmental operating conditions)
• additional future applications and wider markets for exploitation
• wider collaborations and networks you have already developed or any additional relationships you see as a requirement to support exploitation
• how your product could be tested in a representative environment in later phases
• any specific legal, ethical, commercial or regulatory considerations for exploitation

7.3 Is your exploitation plan long term?

Long term studies may not be able to articulate exploitation in great detail, but it should be clear that there is credible advantage to be gained from the technology development.

Include project specific information which will help exploitation. This competition is being carried out as part of a wider MOD programme and with cognisance of cross-Government initiatives. We may collaborate with organisations outside of the UK Government and this may provide the opportunity to carry out international trials and demonstrations in the future.

8. How to apply

Submission deadline

Midday on 22 September 2022

Where do I submit my proposal?

Via the DASA Online Submission Service for which you will be required to register.

Only proposals submitted through the DASA Online Submission Service will be accepted.

Total funding available

£1M (Exc. VAT) funding is available and 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) that that demonstrates value for money, provides high quality supporting evidence of platform performance to date as well as a detailed project plan to deliver on the competition challenges.

Contracts will be awarded for a duration of up to 14 months from 03 January 2023 and must complete by 28 February 2024 (although proposals of shorter duration will also be accepted).

How many proposals will DASA fund

DASA will fund up to two proposals under the £1M (Exc. VAT) funding currently available.

For further guidance

Click here for more information on our competition process and how your proposal is assessed.

Queries should be sent to the DASA Help Centre: [email protected].

8.1 What your proposal must include

• the proposal should focus on the Phase 2 requirements but must also include a brief (uncosted) outline of the next stages of work required for commercial exploitation
• when submitting a proposal, you must complete all sections of the online form, including an appropriate level of technical information to allow assessment of the bid and a completed finances section
• completed proposals must comply with the financial rules set for this competition. The upper-limit for this competition is £1M (Exc. VAT). Proposals will be rejected if the financial cost exceeds this capped level.
• you must include a list of other current or recent government funding you may have received in this area if appropriate, making it clear how this proposal differs from this work
• a realistic project plan clearly defining how TRL5 will be achieved through project work packages, the key milestones within each work package and the deliverables to be provided to Dstl. Deliverables must be well defined and designed to provide evidence of progress against the project plan; the end point of the competition must include a final report in accordance with DASA Terms and Conditions. Please note that all Reports included as Deliverables under the Contract e.g. Progress and/or Final Reports etc. must comply with the Defence Research Reports Specification (DRRS) which defines the requirements for the presentation, format and production of scientific and technical reports prepared for MOD. Final Reports shall describe the entire work performed under the Contract in sufficient detail to explain comprehensively the work undertaken across all work packages and the results achieved including all relevant technical details of any hardware, software, process or system developed there under. The technical detail shall be sufficient to permit independent reproduction of any such process or system.
• a payment plan which is linked to evidenced deliverables.
• you should plan for attendance at a kick-off meeting at the start of Phase 2, and a closure meeting at the end of the contract, as well as regular reviews with the appointed Dstl Technical Partner and Project Manager. All regular updates may take place virtually, and any face to face progress meetings must be held in the UK. An in-person meeting at your location of work will take place on an agreed date during the contract. If an overseas supplier is successful, we will endeavour to visit your location of work, however this may not be possible.
• At each review meeting you will provide updates on progress made against each work package, milestones achieved and deliverables provided, together with any issues that may have arisen and work yet to be completed within the remainder of the contract duration.
• your proposal must demonstrate how you will complete all activities/services and provide all deliverables within the competition timescales (by 28 February 2024). Proposals with any deliverables (including final report) outside the competition timeline will be rejected as non-compliant.
• a cyber risk assessment must have been completed and the result received and included in the proposal.

8.2 What your resourcing plan should include

Your resourcing plan must identify, where possible, the nationalities of proposed employees that you intend to work on this phase.

If your proposal is recommended for funding

In the event of a proposal being recommended for funding, the DASA reserves the right to undertake due diligence checks including the clearance of proposed employees. Please note that this process will take as long as necessary and could take up to 6 weeks in some cases for non-UK nationals.

You must identify any ethical / legal / regulatory factors within your proposal and how the associated risks will be managed, including break points in the project if approvals are not received.

Due to time constraints, proposals that require MODREC will not be considered at this stage. If you are unsure if your proposal will need to apply for MODREC approval, then please refer to the MODREC Guidance for Suppliers or contact your Innovation Partner for further guidance.

Requirements for access to Government Furnished Assets (GFA), for example, information, equipment, materials and facilities, may be included in your proposal. DASA cannot guarantee that GFA will be available. If you apply for GFA, you should include an alternative plan in case it is not available.

Failure to provide any of the above listed will automatically render your proposal non-compliant.

8.3 Export control for overseas partners

All relevant export control regulations will apply if a company ultimately wants to sell a developed solution to a foreign entity. All innovators must ensure that they can obtain, if required, the necessary export licences for their proposals and developments, such that they can be supplied to the UK and other countries. If you cannot confirm that you can gain the requisite licences, your proposal will be sifted out of the competition.

Additionally, if we believe that you will not be able to obtain export clearance, additional checks may be conducted, which may also result in your proposal being sifted out of the competition.

8.4 Cyber risk assessment

Supplier Assurance Questionnaire (SAQ)

Innovators must complete a Supplier Assurance Questionnaire (SAQ), using the DASA Risk Assessment Reference (RAR) for this competition: RAR- 675938023 and answer questions for risk level “Very Low”.

DASA has completed a Cyber Risk Assessment (CRA) for this competition. In order to submit to this competition innovators are required to work towards cyber resilience. If selected for funding, the innovator must prove cyber resilience before a contract will be awarded.

Defence Cyber Protection Partnership

The Defence Cyber Protection Partnership (DCPP) will review your SAQ submission and respond with a reference number within 2 working days. The completed SAQ form and resulting email response from DCPP must be downloaded and included within the DASA submission service portal when the proposal is submitted. Please allow enough time to receive the SAQ reference number prior to competition close at midday on 22 September 2022.

If the proposal is being funded, the SAQ will be evaluated against the CRA for the competition, and it will be put it into one of the following categories:

1. compliant – no further action
2. not compliant – if successful in competition and being funded, the innovator will be required to complete a Cyber Implementation Plan (CIP) before the contract is placed, which will need to be reviewed and agreed with the relevant project manager

Innovators can enter a proposal without all controls in place, but are expected to have all the cyber protection measures necessary to fulfil the requirements of the contract in place at the time of contract award, or have an agreed Cyber Implementation Plan (CIP).

The CIP provides evidence as to how and when potential innovators will achieve compliance. Provided the measures proposed in the Cyber Implementation Plan do not pose an unacceptable risk to the MOD, a submission with a Cyber Implementation Plan will be considered alongside those who can achieve the controls.

A final check will be made to ensure cyber resilience before the contract is placed. Commercial staff cannot progress without it. This process does not replace any contract specific security requirements.

Further guidance for completing this process can be requested by emailing the DASA Help Centre: [email protected].

Additional information about cyber security can be found at: DCPP: Cyber Security Model industry buyer and supplier guide.

8.5 Public facing information

When submitting your proposal, you will be required to include a title and a short abstract. The title and abstract you provide will be used by DASA, and other government departments, to describe your project and its intended outcomes and benefits. They may be included at DASA events in relation to this competition and in documentation such as brochures. The proposal title will be published in the DASA transparency data on GOV.UK, along with your company name, the amount of funding, and the start and end dates of your contract. As this information can be shared, it should not contain information that may compromise Intellectual property.

8.6 How your proposal will be assessed

At Stage 1, all proposals will be checked for compliance with the competition document and may be rejected before full assessment if they do not comply. Only those proposals that demonstrate compliance against the competition scope and DASA mandatory criteria will be taken forward to full assessment.

8.7 Mandatory Criteria

The proposal outlines how it meets the scope of the competition	Within scope (Pass) / Out of scope (Fail)
The proposal fully explains in all three sections of the DASA submission service how it meets the DASA criteria	Pass / Fail
The proposal clearly details a financial plan, a project plan and a resourcing plan to complete the work proposed in Phase 2	Pass / Fail
The proposal confirms MODREC approval is not required	Pass / Fail
The proposal confirms whether or not any GFA required for Phase 2	Pass / Fail
Maximum value of proposal is £1M (Exc. VAT)	Pass / Fail
The proposal demonstrates how the initial research and development activities / services (including delivery of the final report) will be completed by 28 February 2024.	Pass / Fail
The bidder has obtained the authority to provide unqualified acceptance of the terms and conditions of the Contract	Pass / Fail
The bidder has done all of the following: submitted a Supplier Assurance Questionnaire (SAQ) number; attached the email from DCPP; attached the submitted SAQ form	Pass / Fail

Proposals that pass Stage 1 will then be assessed against the standard DASA assessment criteria (Desirability, Feasibility and Viability) by subject matter experts from the MOD (including Dstl), other government departments and the front-line military commands. You will not have the opportunity to view or comment on assessors’ recommendations.

DASA reserves the right to disclose on a confidential basis any information it receives from innovators during the procurement process (including information identified by the innovator as Commercially Sensitive Information in accordance with the provisions of this competition) to any third party engaged by DASA for the specific purpose of evaluating or assisting DASA in the evaluation of the innovator’s proposal. In providing such information the innovator consents to such disclosure. Appropriate confidentiality agreements will be put in place.

After assessment, proposals will be discussed internally at a Decision Conference where, based on the assessments, budget and wider strategic considerations, a decision will be made on the proposals that are recommended for funding.

Innovators are not permitted to attend the Decision Conference.

Proposals that are unsuccessful will receive brief feedback after the Decision Conference.

8.8 Things you should know about DASA contracts: DASA terms and conditions

Please read the DASA terms and conditions which contain important information for innovators. For this competition we will be using the Innovation Standard Contract (ISC) Terms and Schedules. We will require unqualified acceptance of the terms and conditions; if applicable, please ensure your commercial department has provided their acceptance.

Funded projects will be allocated a Project Manager (to run the project) and a Technical Partner (as a technical point of contact). In addition, the DASA team will work with you to support delivery and exploitation including, when appropriate, introductions to end-users and business support to help develop their business.

We will use deliverables from DASA contracts in accordance with our rights detailed in the contract terms and conditions.

For this competition, £1M (Exc. VAT) is currently available to fund proposals. There may be occasions when additional funding may become available to allow us to revisit proposals deemed suitable for funding. Therefore, DASA reserves the right to keep such proposals in reserve. In the event that additional funding becomes available, DASA may ask whether you would still be prepared to undertake the work outlined in your proposal under the same terms.

9. Phase 2 key dates

Q & A Dial-in	3rd August 2022
Pre bookable 1-1 telecom sessions	9th August 2022, 17th August 2022 and 6th September 2022
Competition closes	Midday (BST) 22nd September 2022
Feedback release	21st November 2022
Contracting	Aim to start 3rd January 2023 and must end by 28th February 2024

10. Help: Contact the DASA Help Centre

Competition queries including on process, application, commercial, technical and intellectual property aspects should be sent to the DASA Help Centre at [email protected], quoting the competition title. If you wish receive future updates on this competition, please email the DASA Help Centre.

While all reasonable efforts will be made to answer queries, DASA reserves the right to impose management controls if volumes of queries restrict fair access of information to all potential innovators.