Notice

Competition document: point of care diagnostics at the front line

Updated 30 July 2019

1. Introduction

The Defence and Security Accelerator (DASA) is seeking proposals for innovative ‘Point of Care’ (PoC) diagnostics technologies that provide information to enable clinicians to earlier diagnose and ultimately treat individuals exposed to chemical and biological hazards.

2. Competition Scope

2.1 Background

Defence against debilitating infectious agents, including those associated with biological warfare (BW) use, represents a key challenge for UK armed forces. Throughout the history of armed conflict, Disease and Non-Battle Injury (DNBI), particularly infection, has caused significant morbidity and mortality among deployed forces. This disparity remains current.

Recent events have highlighted the need for the UK to develop rapid medical diagnostic technologies. These technologies will support affected individuals, first responders and personnel involved in recovery response work.

Technologies that enable rapid diagnosis of individuals exposed to biological or chemical agents are currently limited. They are time-consuming, resource intensive, provide a limited identification capability and frequently rely on reach-back to laboratory facilities. This limits the clinical timeliness and thus usefulness of the results generated. PoC diagnostic devices represent an attractive solution to this problem. These may be used in austere environments by UK Armed Forces. They may also be used in a doctor’s surgery or at the patient’s bedside. Regardless of location, it is anticipated that such devices will provide quick feedback and impact significantly on the trajectory of patient care. There is a requirement for novel PoC diagnostic device solutions for deployment by UK Forces in a variety of scenarios.

2.2 Scope

At present, there is a limited diagnostic capability within overseas theatres of operations. Complicated multiplex technologies, capable of detailed analysis of patient samples, are generally found at locations where infrastructure is good and 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 technologies that would enable the diagnosis of individuals exposed to a wide variety of agents, regardless of starting Technology Readiness Level (up to TRL 6). These technologies can be targeted at the agents themselves or at host biomarkers that change as a result of exposure.

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

3. Competition Challenge

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 sample preparation steps for complex clinical samples; (blood, serum, plasma, saliva etc)
• provide a rapid (less than 1 hour) time to answer, to facilitate delivery of timely information to clinicians to inform treatment options
• suitable for, or can be adapted for, use by non-expert users; i.e. minimal manual steps required for that user to perform the assay and output of easily interpretable results
• 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
• high levels of equipment reliability in resource limited settings, which may include high and low ambient temperatures
• suitable for, or can be adapted to use with, minimal reliability on the presence of other associated lab infrastructure (to include air conditioning, mains power) and/or a large array of additional standard laboratory equipment (such as centrifuges, refrigerators and freezers)
• suitable for, or can be adapted for, the detection of multiple analytes simultaneously
• flexible and adaptable to integration of new assays for additional analytes to facilitate identification of a broad spectrum of agents
• minimal equipment footprint; equipment is currently or can be made portable by an individual with minimal additional burden to that individual

It is anticipated that successful platforms will be able to be exploited in both the military and clinical sectors with applications in deployed environments, primary and secondary healthcare settings.

Each project should aim to demonstrate the mechanism of detection proposed according to the above aspirations. This demonstration can be undertaken during this phase using any appropriate platforms and assays already available to the proposer.

For proposals where reagents are required to demonstrate assay performance, details of specific assays and reagents should be included in the proposal in order for us to baseline and compare the performance of different platforms.

Depending on the detection approach, where relevant, each proposer should aim to incorporate assays specific for the following materials. Please note that we have included links to known assay components from specific manufacturers which meet the required standard; if you wish to use the equivalent product from other manufacturers please check with DASA that it meets the specification;

• for platforms aiming to detect protein based analytes: Ovalbumin (Sigma; A5503) should be included as a target analyte. Up to 4 monoclonal and 1 polyclonal antibodies (10 mg for each successful proposal) will be provided to each successful proposal to detect this analyte. Information regarding performance of these antibodies in standard enzyme-linked immunosorbent assays (ELISA) will be provided
• for platforms aiming to detect agent specific nucleic acid analytes: DNA extracted / analysed from samples spiked with known concentrations of a certified standard (Staphylococcus aureus NCTC 10788, available in Bioball format) should be used to enable design and testing of nucleic acid targeting assays
• for platforms targeting diagnosis of nerve agent exposure via enzyme inhibition/activity human recombinant acetylcholinesterase (Sigma; C1682) should be used to enable development of assays appropriate to measure the full range of natural human acetylcholinesterase activity levels. Information on the acetylcholinesterase activity within a normal human population will be provided to inform assay design. It is not intended for proposals to determine inhibition of enzyme function within this phase of the DASA call

If only one assay is to be demonstrated within the confines of the Phase 1 proposal, proposers should select the most appropriate assay from those described above.

3.1 Clarification of what we want

For Phase 1, in line with the requirements listed above, DASA is seeking proposals that demonstrate feasibility of novel approaches for detection of low levels of analyte in complex sample types. Applicants are directed to focus on the development of novel sensor transduction mechanisms or concepts that have the capability of overcoming the logistical and user burden associated with current platforms. 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.

Technologies appropriate for this call at Phase 1 could currently exist at a range of TRLs up to TRL 6. Where lower TRL options (TRL 1-2) which offer innovative methodologies of detection are proposed, the supplier should aim to demonstrate proof-of-concept of detection of the chosen model agent in a complex sample background as a minimum. Where more established, higher TRL platforms (TRL 3-6) are proposed, suppliers should aim to demonstrate ease of adaptation of the current platform to detect the model analytes proposed.

It is anticipated that by the end of Phase 1 all technologies will have demonstrated a minimum of TRL of 3.

Future phases of work will aim to further raise the TRL technologies towards a higher TRL. Funding is provisionally available to achieve a minimum of TRL 4 by the end of the Phase 2.

3.2 Clarification of what we don’t want

For this competition 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 (which therefore cannot be extended into Phase 2)
• do not offer significant benefit to defence and security capability
• are an identical resubmission of a previous bid to DASA or MOD without modification
• 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

4. Exploitation

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 be dependent on the nature and starting point of the innovation. Early identification and appropriate engagement with potential end-users during the competition and subsequent phases are essential.

All proposals to DASA should articulate the expected development in TRL 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. For further information on TRLs, please see here. Your deliverables should be designed to evidence these aspects with the aim of making it as easy as possible for possible collaborators to identify the innovative elements of your proposal in order to consider routes for exploitation. DASA Innovation Partners are available to support you with defence and security context.

A higher technology maturity will be expected in subsequent phases. You may wish to include some of the following information, where known, to help the assessors understand your exploitation plans:

• 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
• requirements for access to external assets, including Government Furnished Assets (GFA) - for example, information, equipment, materials and facilities
• how your product could be tested in a representative environment in later phases
• any specific legal, ethical, commercial or regulatory considerations for exploitation

5. How to apply

Proposals for funding to meet these requirements must be submitted by 26 September 2019 at midday (BST) via the DASA submission service, for which you will be required to register.

The funding of £500k is expected to fund 3 to 5 proposals. The value of proposals should range from £50k to £150k. If successful, contracts will be awarded for a duration of up to 12 months (although proposals of shorter duration are also valid).

Additional funding for further phases to increase the TRL is potentially available. Any further phases will be open to applications from all suppliers and not just those that submitted successful Phase bids. Further guidance on submitting a proposal is available on the DASA website.

5.1 What your proposal must include

The proposal should focus on the Phase 1 requirements but must also include a brief (uncosted) outline of the next stages of work required for 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 £150k. Proposals will be rejected if the financial cost exceeds this capped level.

A project plan with clear milestones and deliverables must also be provided. Deliverables must be well defined and designed to provide evidence of progress against the project plan and the end-point for this phase. Deliverables must include a final report as a minimum. You should plan for attendance at a kick off meeting at the start of Phase 1 and a demonstration event at the end of Phase 1 as well as regular reviews with the appointed Technical Partner which will be in the UK. Your proposal must demonstrate how you will complete all activities/services and provide all deliverables within the competition timescales (12 months maximum duration). Proposals with any deliverables (including final report) outside the competition timeline will be rejected as non-compliant.

A resourcing plan must also be provided that identifies, where possible, the nationalities of those proposed Research Workers that you intend working on this phase. In the event of proposals being recommended for funding, the DASA reserves the right to undertake due diligence checks including the clearance of proposed Research Workers. 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. MODREC approvals can take up to 3 months therefore you should plan your work programme accordingly. Further details are available in the DASA guidance. If you are unsure if your proposal will need to apply for MODREC approval, then please contact DASA for further guidance.

In addition, requirements for access to GFA should be included in your proposal. DASA cannot guarantee that GFA will be available.

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

5.2 Public facing information

When submitting your proposal, you will be required to include a proposal title and a short abstract. If your proposal is funded, the title and abstract you provide will be used by DASA, and other government departments as appropriate, to describe the project and its intended outcomes and benefits. It will be used for inclusion at DASA events in relation to this competition and included in documentation such as brochures for the event. This proposal title will also be published in the DASA transparency data on GOV.UK, along with your company name, organisation type e.g. Small and Medium Sized Enterprise (SME) and the amount of funding received.

5.3 How your proposal will be assessed

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 who demonstrate their compliance against the competition scope and DASA assessment criteria will be taken forward to full assessment. Failure to achieve full compliance against stage 1 will render your proposal non-compliant and will not be considered any further:

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 1	Pass / Fail
The proposal identifies the need (or not) for MODREC approval	Pass / Fail
The proposal identifies any GFA required for Phase 1	Pass / Fail
Maximum value of proposal is £150k	Pass / Fail
The proposal demonstrates how all activities/services (including delivery of the final report) will be completed within 12 months from award of contract (or less)	Pass / Fail
The bidder provides unqualified acceptance of the terms and conditions of the Contract.	Pass / Fail

Proposals will then be assessed against the standard DASA assessment criteria by subject matter experts from the MOD (including Dstl), other government departments and front-line military commands. You will not have the opportunity to comment on assessors comments. DASA reserves the right to disclose on a confidential basis any information it receives from bidders during the procurement process (including information identified by the bidder 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 bidder’s proposal. In providing such information the bidder consents to such disclosure. Appropriate confidentiality agreements will be put in place.

Further guidance on how your proposal is assessed is available on the DASA website.

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.

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

5.4 Things you should know about DASA contracts

Please read the DASA terms and conditions which contain important information for suppliers. For this competition we will be using the Standard Contracting (SC) Innovation Contract – Terms and Schedules. For the avoidance of doubt, this is not the Short Form Contract (SFC).

Funded projects will be allocated a Technical Partner as a technical point of contact. In addition, the DASA team will work with you to support delivery and exploitation.

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

For this phase/competition, £500k is currently available to fund proposals. There may be occasions where additional funding from other funding lines may subsequently become available to allow us to revisit those proposals deemed suitable for funding but where limitations on funding at the time prevented DASA from awarding a subsequent Contract. In such situations, DASA reserves the right to keep such proposals in reserve. In the event that additional funding subsequently becomes available, DASA may ask whether you would still be prepared to undertake the work outlined in your proposal under the same terms. Your official DASA feedback will indicate if your proposal was fundable or not.

6. Phase 1 Dates

Dial-in	25 July 2019 AM & 4 September 2019 AM
Pre bookable 1-1 telecom sessions	25 July 2019 PM & 4 September 2019 PM
Competition closes	26 September 2019
Contracting	Aim to start December 2019 and end up to 12 months later

6.1 Supporting events

25 July 2019 AM - 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 25 July 2019 Dial in Eventbrite page.

25 July 2019 PM - A series of 20 minute one-to-one teleconference sessions, giving you the opportunity to ask specific questions. If you would like to participate, please register on the 25 July 2019 1-1s Eventbrite page

04 September 2019 AM - 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 04 September 2019 Dial in Eventbrite page.

04 September 2019 PM - A series of 20 minute one-to-one teleconference sessions, giving you the opportunity to ask specific questions. If you would like to participate, please register on the 04 September 2019 1-1s Eventbrite page.

7. Help

Competition queries including on process, application, technical, commercial and intellectual property aspects should be sent to accelerator@dstl.gov.uk, quoting the competition title.

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 suppliers.