Attachment A - Statement of Objectives (SOO) (22 Apr 2024).docx

Attachment A – Statement of Objectives (SOO)

Statement of Objectives (SOO) for Prototype for Rapid Donor Screening

1.0 PURPOSE

This is a feasibility prototype development effort, to determine whether the needs of the Department of Defense (DoD) can be achieved.

This Statement of Objectives (SOO) is intended to result in a single award to develop a rapid donor screening (RDS) technology that is U.S. Food and Drug Administration (FDA) cleared with a donor screening indication. DoD is seeking multiplexed assays for HIV-1 and -2, Hepatitis B and C, blood type and Rh factor, that use a whole blood sample and provides results in 20 minutes or less. The RDS shall ultimately support screening blood from the donors in conflict zones. The DoD requires technology that is rugged, lightweight, compact, and that operates with no requirement for connectivity to a cloud domain. Therefore, technologies starting at a Technology Readiness Level (TRL) 3 or higher are preferred in order to achieve this goal. The ideal solution for the DoD shall combine the infectious disease targets with blood type targets, but we understand that combining these into a single multiplex panel may not be technically feasible.

2.0 BACKGROUND

During military operations in conflict zones, the US military relies on blood products delivered from US blood donor centers to the greatest extent possible. However, when blood supply chain interruptions occur or the demand for blood products exceeds available supply, then Service Members on site are asked to donate blood as a contingency solution until blood deliveries are resumed. In the Iraq and Afghanistan conflicts stored blood products supplemented with Walking Blood Bank (WBB) collections were adequate to meet the demand for treatment. However, in future large-scale combat operations the demand for and supply of blood products shall exceed historical volumes available in theater, and resupply shall be challenged by near-peer adversaries. This shall place greater demand on the WBB. Ensuring donated blood is free from HIV-1 and -2, Hepatitis B and C, and is a compatible blood type, is essential to safety and ultimately positive outcomes for the patients.

At present, all the Services (U.S. Army, U.S. Navy, U.S. Air Force, U.S. Marine Corps, and U.S. Special Operations Forces) use three (3) separate rapid tests for HIV, Hepatitis B, and C, which are approved as diagnostics; each takes 30 minutes or longer for results. Blood typing is accomplished using a separate assay (Eldon cards) and requires an experienced user to interpret the results accurately. Frequently, local nationals, enemy combatants, and Coalition Forces are treated by US medical providers alongside US Service Members, and their blood type is usually unknown. Having a single multiplex panel that provides easily interpreted results for HIV 1 & 2, Hepatitis B and C, and blood type shall significantly increase efficiency of donor screening and blood collections.

3.0 SCOPE OF EFFORT

Objective 1 shall determine whether a multiplex of 2 or less RDS, with desired assays, can be achieved. If the goals of Objective 1 are achieved (e.g., HIV-1 and -2, Hepatitis B and C, blood type and Rh factor multiplexed in no more than two (2) separate panels), development of the prototype shall continue to Objectives 2, 3, and 4 (optional objectives to be exercised at the Government’s discretion), ultimately resulting in an FDA cleared assays with donor screening indications that meets the requirements of the DoD. During or at the conclusion of Objective 2, the RDS shall be assessed by subjective matter experts and tested against environmental and physical conditions encountered in austere environments and onboard ships.

NOTE: Objectives 2 - 4 are optional Objectives to be exercised at the Government’s discretion. However, if the Performer feels some of the work under Objective 2 can be accomplished/completed under Objective 1 AND within the 24-month time period, the Performer is free to propose the best solution for Objective 1 within their Technical Approach and Statement of Work (SOW).

Follow-on requirement for future expansion may be needed of the multiplex include targets of 10 or more. Examples include syphilis (T. pallidum), Human T-lymphotropic virus type 1 (HTVL I) and type II (HTLV II), Trypanosoma cruzi (Chagas disease) and low-titer O (defined as no greater than 1:250 anti-A and anti-B). However, this is not part of the scope for this requirement and is only intended to provide insight into potential future efforts.

4.0 OBJECTIVES

This award includes 4 phases/objectives of development and evaluation of the RDS technology.

Objective 1: The Performer shall ensure Objective 1 leads to functional multiplexed assays for the specified targets, which will be assessed by DoD subject matter experts for assay performance and potential to meet desired performance attributes. Therefore, technologies starting at Technology Readiness Level (TRL) 3 or higher are preferred in order to achieve a prototype for performance assessments. The Performer shall coordinate a kick-off meeting with Government and produce meeting minutes (Deliverable 1). Participate in quarterly status meetings (Deliverable 2). Complete Quarterly report, including updates to the Project Management Plan (PMP) (i.e., Risk Management Plan, Staffing Plan, and Integrated Master Schedule (IMS)) (Deliverable 3). Complete a monthly spend plan (Deliverable 4). A prototype development report (Deliverable 5) containing assay design and testing, feasibility assessments and preliminary assay verification studies shall be submitted and include descriptions of assay reagent selection and development, multiplex design decisions, test data, and data summaries. Prior to use of human and animal blood samples in assay development and testing, the Performer shall obtain approval of assay development protocol from an Institutional Animal Care & Use Committee (IACUC) and U.S. Army Medical Research and Development Command’s (USAMRDC) Office of Human and Animal Research Oversight (OHARO) (Deliverable 6). The Performer shall travel to a government location to provide an in-person presentation/demonstration of the assays. The government location will be determined at a later date (Deliverable 7). The final product of Objective 1 is a working prototype of multiplexed assays. In addition to the above, the following shall be completed under Objective 1, however additional tasks may be anticipated or needed:

- Select compatible target detection method(s) for required tests.

- Design and develop or modify existing test reagents.

- Modify existing device platforms if required to accommodate multiplexed assays.

- Manufacture reagents required for new or modified assays.

- Design/modify/integrate sample preparation and introduction processes and devices.

- Conduct technical feasibility assessments on multiplex design and modify, as required. - Complete preliminary verification testing on device/multiplex combination. Assay sensitivity and specificity must be 99.5%.

The Performer shall include all needed tasks in the statement of work and milestones.

Objective 2: (optional): The Performer shall ensure Objective 2 leads to an Investigational Device Exemption (IDE) submission to FDA (Deliverable 8). Participate in quarterly status meetings (Deliverable 2). Prior to use of human and animal blood samples in assay development and testing, the Performer shall obtain approval of assay development protocol from an IACUC and USAMRDC OHARO (Deliverable 14). Submit revisions to Regulatory Strategy for Government approval (Deliverable 9). Complete quarterly status report, including updates to the PMP (i.e., Risk Management Plan, Staffing Plan, and IMS) (Deliverable 3). Complete a monthly spend plan (Deliverable 4). Submission of FDA written responses and meeting summary(ies) for clinical specimen study design and stability study design (Deliverable 10) is required to progress to Objective 3. The following tasks are not inclusive of all activity that may be required to submit an IDE to FDA:

- Refine prototype assays based on preliminary verification results.

- Complete assay validation studies (sensitivity, specificity, accuracy, precision) and modify assays that do not meet performance standards for donor screening.

- Complete accelerated stability studies of reagents based on DoD performance specifications.

- Develop clinical specimen study protocol, identify study sites, and prepare and submit all required IDE documents for meeting with FDA. A minimum of two (2) Government representatives shall be included in the IDE meeting with FDA.

Reports of test results for the following studies are required at the end of Objective 2:

- Assay verification studies, assay validation studies, and accelerated assay stability studies (Deliverable 11).

Provide a minimum of five (5) mature RDS prototypes and instructions for use to the DoD for developmental testing and evaluation (Deliverable 12).

- A demonstration of the final RDS technology shall be provided following delivery to end users for developmental testing and operational test and evaluation (Deliverables 13); demonstrations may be virtual or in person.

The Performer shall include all needed tasks in their Performer’s statement of work and milestones.

Objective 3: (optional) Performer shall ensure Objective 3 includes all studies required for device 510(k) clearance or Pre-Market Approval (PMA) by FDA and shall lead to an application to the Agency. Prior to use of human and animal blood samples in assay development and testing, the Performer shall obtain approval of assay development protocol from an IACUC and USAMRDC OHARO (Deliverable 14). These include, but are not limited to, preparing and submitting an IDE to FDA (Deliverable 8). Complete clinical specimen studies based on the approved protocol(s) and delivering the final study report (Deliverable 15). Complete stability studies on final device and multiplex assays and delivering final report (Deliverable 16). Performer shall provide up to fifty (50) RDS devices with 5 multiplex panels each for purchase by the Government for operational test and evaluation, including instructions for use and technical manuals (Deliverable 17). Establish or modify a commercial manufacturing capacity to produce the final technology for commercialization (Deliverable 18). Delivering notice of FDA clearance or approval of the RDS (Deliverable 19). Participate in quarterly status meetings (Deliverable 2). Complete quarterly status report, including updates to the PMP (i.e., Risk Management Plan, Staffing Plan, and IMS) (Deliverable 3). Complete a monthly spend plan (Deliverable 4).

The Performer shall include all needed tasks in the statement of work and milestones.

Objective 4: (optional) The Performer shall ensure Objective 4 completes post-FDA clearance/approval studies for Clinical Laboratory Improvement Amendment (CLIA) waivers. If technology qualifies as minimal complexity per FDA definitions, then the Performer shall submit a study design to FDA and obtain clearance for execution, complete the CLIA waiver studies (Deliverable 20), and submit the final report to FDA to obtain CLIA waiver for the RDS technology. Prior to use of human and animal blood samples in assay development and testing, the Performer shall obtain approval of assay development protocol from an IACUC and USAMRDC OHARO (Deliverable 14). Participate in quarterly status meetings (Deliverable 2). Complete quarterly status report, including updates to the PMP (i.e., Risk Management Plan, Staffing Plan, and IMS) (Deliverable 3). Complete a monthly spend plan (Deliverable 4).

The Performer shall include all needed tasks in the statement of work and milestones.

5.0 PERIOD OF PERFORMANCE

The estimated period of performance (PoP) for Objective 1 is 24 months. The estimated PoP for Objectives 2 through 4 is 66 months. Total project performance is 90 months. If all objectives can be accomplished/completed in less time, it is highly desirable.

Objective 1 – 24 months Objective 2 (optional) – 12 months Objective 3 (optional) – 42 months Objective 4 (optional) – 12 months

6.0 LOCATION

RDS development shall be conducted at Performer location.

DoD-led operational and developmental testing and evaluation shall be performed at DoD installations. The Performer may be asked to be present on-site during operational testing and evaluation to provide instruction and observe testing.

7.0 TRAVEL

The Performer shall be authorized travel expenses consistent with the substantive provisions of the applicable travel regulations and the limitation of funds specified in the agreement.

Arrangements for all travel, transportation, meals, lodging, and incidentals are the responsibility of the Performer. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the Government. The Government shall not pay for business class or first-class travel.

Travel of 1 to 3 Performer personnel (ex: project manager and technical developers) may be required to support technical demonstrations and training at DoD facilities in San Antonio, TX; San Diego, CA, Marine Corps Base Quantico, VA; and Fort Liberty, NC. Travel to other locations may be required for prototype demonstrations and meetings, to professional and DoD conferences, and to qualify or audit a component or material supplier.

8.0 CONSTRAINTS

Research under this award involving the use of human subjects, to include the use of human tissues or identifiable private information, shall not begin until OHARO provides authorization that the research may proceed. Written approval to begin research shall be issued from OHARO, under separate notification to the recipient. Written approval from OHARO is also required for any sub-awardee that shall use funds from this award to conduct research involving human subjects or human tissues. See Agreement Terms & Conditions, Article 13. General Provisions for submission requirements

Desirable prototype characteristics and performance: To provide reliable performance at all military medical treatment locations (especially far forward (Role 1)), the DoD requires a technology that can achieve most or all the attributes below. It must be rugged, highly portable (small and lightweight), and able to operate without connection to cloud applications. The Objectives to Performance Attribute Cross-walk (Attachment B) describes when each performance attribute shall be achieved for Objectives 1 - 4.

Attribute

Final Device Characteristics & Performance Objectives (Minimum Requirements)

Final Device Characteristics & Performance Objectives

http://everyspec.com/MIL-PRF/MIL-PRF-030000-79999/MIL-PRF-32383_35531/

· Battery type must also be compatible with DoD air worthiness and NAVSEA S9310 requirements, See Joint Enroute Care Equipment Test Standard and NAVSEA S9310-AQ-SAF-010, references:

https://www.wpafb.af.mil/Portals/60/documents/stf-matrix/AFD-160512-024.pdf?ver=2016-09-22-072647-890 http://everyspec.com/USN/NAVSEA/NAVSEA_S9310-AQ-SAF-010_4137/

Operation without power.

http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL_STD_1332B_476/ Operation without power.

http://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-810H_55998/

No impact of vibration or shock on detection and sensitivity.

2 months at 0 to 30⁰C and 5 to 85% RH Refers to stability of the test cartridges and reagents once removed from storage and in an operational environment.

Stability greater than 6 months highly desirable at –20 – +45°C and 2 – 95% RH.

9.0 GOVERNMENT FURNISHED PROPERTY

This requirement will not use Government Furnished Property.

10.0 DELIVERABLES

Method of Delivery: Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS Word, MS Excel, MS PowerPoint, MS Project, or MS Access format), unless otherwise specified by the United States Army Medical Materiel Development Activity (USAMMDA) Agreements Officer’s Representative (AOR). Electronic submission shall be made via email, unless otherwise agreed to by the USAMMDA AOR. The Performer shall make use of commercial best practices in the packing and shipment of packages.

AS

and

AOR

1-4

1-4

1-4

2 & 3

2 & 3

12. Delivery of five

(5) Mature Rapid Donor Screening prototype with instructions for use

2 & 3

2 -4

Report due within 6 months of project completion N/A

11.0 ABBREVIATIONS

(end of SOO)