Advanced Differential Diagnostics (ADD)

RFI #W911SR-23-S-ADD1 REQUEST FOR INFORMATION JOINT PROGRAM EXECUTIVE OFFICE FOR CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR DEFENSE (JPEO-cbRND) Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) under the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) and the Defense Threat Reduction Agency's Joint Science and Technology Office (DTRA-JSTO) are seeking information on the available capabilities and willingness of private entities (academic, non-profit, and commercial) to collaborate with the Government in the areas listed below. Background: As a component of the U.S. Department of Defense's Chemical and Biological Defense Program, the JPEO-CBRND protects the entire Joint Force - Army, Navy, Air Force, Marines, Coast Guard, and First Responders - through the advanced development of CBRN defense capabilities that enable our Warfighters to fight and win in a CBRN-contested environment. DTRA-JSTO conducts early product development efforts for transition to JPEO-CBRND programs of record. The Joint Product Lead for Diagnostics (JPdL-DX), a component of JPM CBRN Medical, is initiating the Advanced Differential Diagnostics (ADD) program. ADD is intended to provide a toolkit of materiel solutions focused on early medical intervention across the entire deployed medical community (Role 3, Role 2, Role 1, and Small Team) for the infectious disease states most likely to impact force readiness and effectiveness. By providing a - broad brush approach to diagnostics, medical providers will be able to effectively identify and triage pre-symptomatic and symptomatic patients. Diagnostic tests that leverage this approach, for example, may focus on host-based analytes generated in response to insult rather than targeting the highly specific genetic signature of individual viruses, or bacteria leading to disease. Host biomarkers can be biochemical (e.g., inorganic or organic molecules or markers of cellular activity) or genetic markers (e.g., DNA or RNA) derived from biological samples (blood, breath, saliva etc.). A host biomarker diagnostic test ideally provides an objective measure to, at a minimum, categorize an individual's illness and enable actionable treatment decisions. The Department of Defense is specifically interested in the following areas: Host-response biomarkers that could be utilized as government-furnished information in further DoD development efforts on third party commercial diagnostic platforms (developmental licenses with options for commercial licensing) Tests or products that leverage host-response biomarkers to differentiate: Bacterial, viral, and/or fungal infections - Sick patients and healthy patients (prognostic) Severity of illness based on host-response biomarkers (inflammatory or other) Contagiousness of a patient Tests that align with other broad-spectrum treatment decisions (i.e., do not rely on identification of specific pathogen) Acute febrile illness (AFI) is one of the most common reasons for seeking medical care. Although there are both infectious and noninfectious causes for febrile illness, AFI most often follows infection by a wide diversity of pathogens such as bacteria, viruses, fungi, and parasites. Many of these infections can be treated with targeted therapy, but without validated diagnostic tests, they can be indistinguishable from one another even with clinical history and physical examination information. Tests that can reliably diagnose bacterial infections (e.g., cultures) are cumbersome or relegated to moderate- or high-complexity certified clinical laboratories and not suitable to resource-constrained settings. Requirements: The Government is seeking white papers outlining novel approaches for rapid acquisition with planned milestones to develop and deliver materiel solutions in one or more of the above areas starting in FY24 as part of the Advanced Differential Diagnostics (ADD) program. The purpose of this RFI is to solicit information on the availability of companies with the ability to field capabilities as early as FY28. Responses to this RFI will be used for market research to inform and to develop programmatic and contracting strategies. All responses to this RFI need to be properly marked if they contain proprietary information. Access to submissions and subsequent analyses conducted based on submissions will be protected with appropriate markings. Release of information outside of the USG will not be authorized. White Paper Instructions Section 1 of the White Paper should include the following information: Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated point of contact. Business type (large business, small business, small-disadvantaged business, 8(a)-certified small-disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business) Whether the business has executed a contract using an approved Cost Accounting System (CAS) or is otherwise considered a traditional defense contractor The facility security clearance of the offeror (if no clearance exists, answer NONE) A one-paragraph synopsis of the white paper Section 2 should include the following information: All respondents should describe the target and intended use of the test, biomarker(s), or technology in 1-2 paragraphs. For respondents describing biomarkers adaptable to other instrument platforms: Summarize the intended use of the biomarker panel Described the general workflow required to generate a result (sample type, sample processing, reading and interpreting results, etc.) Describe the level of analytical verification and clinical validation that has been conducted with the biomarker panel Describe the instrumentation used during research for biomarker panel validation Describe any current partnerships with industry or academia Describe any limitations to licensing biomarkers to USG for advanced development, Government use, or commercial use Describe any Intellectual Property (IP) ownership complications or inherited IP Identify relevant US patents and indicate whether they are pending or granted For respondents describing approaches involving tests that require specific instrument platform(s), whether under development or marketed, address the following for the complete system: Intended use of the system System requirements and workflow (e.g., sample type, sample processing, reading and interpreting results) Current state of technological maturity for the system including: Component and/or breadboard validation(s) in a laboratory environment (basic technological components have been integrated to establish that they will work together) Modules and/or subsystems validations in a laboratory environment (i.e., software prototype development environment; basic software components are integrated to establish that they will work together) Producibility assessments of design concepts completed Willingness to provide an on-site demonstration on Ft. Detrick in Frederick, MD if requested Durability: disposable or reusable Throughput: single-sample or high-throughput Operational environment Opportunity for system ruggedization for extreme environments Size and weight Power source requirements (if applicable). Comment on alternative power sources (e.g., battery operable) Operator training requirements Relevant US patents: pending or granted Completed clinical validation with relevant biomarker panel Experience working under FDA regulatory oversight Briefly describe regulatory strategies for the system Briefly describe any interactions with the FDA on the specific product described in the white paper FDA clearances, approvals, or authorizations currently held by the applicant company Describe the company's monthly manufacturing capacity for the system and if manufacturing is in-house or by a CMO Describe, in broad terms, supply chain required for product and any at-risk raw materials Submissions should: use Microsoft Word or Adobe Portable Document Format (PDF); be minimum 11-point font on 8.5 X 11 paper with 0.75 margins; not exceed 7 single-sided pages in total (not including cover page and cover letter); be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; and include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es). Other media types (i.e., printed technical information) that meet the submission criteria above will be accepted and should be sent to the Contracting Office Address and Point of Contact identified below. Material that is advertisement only in nature is not desired. Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 11 AUG 2023, 1600 ET. Responses should be sent by email to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil AND usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil@army.mil, with Subject Line denoting the Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI, the first choice for an acquisition vehicle, if appropriate, will be an Other Transaction Agreement (OTA) issued either bilaterally via publicly posted Request for Prototype Proposal (RPP), and/or an RPP issued under the Medical CBRN Defense Consortium (MCDC). Respondents not already members of the MCDC are encouraged to join at www.medcbrn.org. In addition, respondents are encouraged to view the Chemical Biological Radiological and Nuclear Defense (CBRND) Broad Agency Announcement (BAA) in SAM.gov, keywords - CBRND BAA. For questions related to this RFI, please e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, AND usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil. The Points of Contact for this RFI are Richard Totten, at Richard.w.totten2.civ@army.mil and Lee Hess, at lee.a.hess.civ@army.mil.