The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions for a groundbreaking cancer screening initiative. The Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON) program aims to develop at-home, over-the-counter tests for early-stage detection of 30+ solid tumor cancers using breath and/or urine samples. This ambitious project involves two Technical Areas: Technical Area 1 (TA1) focuses on designing synthetic sensors and reporters for cancer detection, while Technical Area 2 (TA2) centers on creating low-cost screening kits integrating hardware, software, and telemedicine capabilities. The program's three phases cover preclinical and clinical development, with strict timelines and performance metrics. Proposals must cover both technical areas and adhere to accessibility, commercialization, and regulatory engagement requirements. ARPA-H seeks to award multiple Other Transaction Agreements, prioritizing solutions that detect a broad range of cancers with high sensitivity and specificity.

The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions for its Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON) program. The goal is to develop accessible at-home tests for early detection of multiple cancers using synthetic biology approaches. POSEIDON aims to reduce cancer deaths and economic burdens by detecting 30+ solid tumor types at Stage 1 through breath and urine samples. The solicitation seeks proposals for developing synthetic sensors and reporters for early cancer detection, with a focus on 30 specific tumor types. Performers must propose solutions for Technical Area 1 (TA1), involving sensor and reporter development, and Technical Area 2 (TA2), centered on creating a low-cost screening kit. The desired kit would enable self-administration, sample collection, and detection without requiring healthcare provider involvement. Proposed solutions must align with the program's three-phase structure, covering discovery and development, non-clinical testing, and clinical testing. Performers are expected to achieve specific technical milestones within each phase, including in silico, in vitro, and in vivo validations. Additionally, commercialization plans, regulatory engagement, and accessibility goals are critical evaluation criteria. Key dates include a proposers' day event on September 4, 2024, and a priority submission deadline of November 6, 2024. ARPA-H intends to award multiple Other Transaction Agreements, with full proposals due in January 2025.

The ARPA-H-SOL-24-109, POSEIDON solicitation focuses on developing advanced at-home Multi-Cancer Early Detection (MCED) tests aimed at early-stage identification of over 30 solid tumors using synthetic biology. The program, titled Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON), seeks whitepapers from eligible entities to create low-cost, accessible tests using breath and urine samples. It emphasizes leveraging innovative synthetic biology and engineering to design sensors and synthetic reporters to detect cancer at Stage I, potentially saving millions of lives and reducing the economic burden of late-stage cancer care. Key objectives include rigorous selection of cancer types for testing, integration with telehealth systems for result transmission, and ensuring accessibility for underserved populations. The solicitation outlines a three-phase structure encompassing discovery, preclinical, and clinical validation, with stringent performance metrics and regular progress evaluations. Multi-disciplinary teams are required to include project management and outreach coordinators, highlighting the importance of equitable healthcare access. Ultimately, POSEIDON aims to transform cancer diagnostics, ensuring technologies are commercialized and accessible at an estimated price of $100 or less.

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals for the POSEIDON program, which aims to develop at-home multi-cancer early detection (MCED) tests targeting 30+ solid tumors. By leveraging synthetic biology, the initiative seeks to create easy-to-use sensors that utilize breath and urine samples for Stage I cancer detection. The program emphasizes accessibility for underserved populations and aims to significantly reduce late-stage cancer diagnoses and related healthcare costs. Proposals will be evaluated based on technical merit, team capabilities, and pricing strategies, with periodic performance evaluations throughout its structured phases, leading to clinical testing. The initiative is expected to enhance early cancer detection, thus improving survival rates while aiming for a final product retail price of under $100 to ensure broad accessibility and affordability. Each proposer must consider regulatory compliance, commercialization pathways, and the development of digital health integration for seamless reporting of results. Overall, the POSEIDON program represents a substantial federal investment in innovative healthcare solutions, aiming to transform cancer diagnostics and treatment accessibility in America.

The ARPA-H solicitation ARPA-H-SOL-24-109 seeks innovative solutions through the POSEIDON program, which aims to develop synthetic-biology-based Multi-Cancer Early Detection (MCED) tests for over 30 solid tumors, targeting early-stage detection through non-invasive breath and urine samples. The program entails three phases: establishing and validating sensors for early cancer detection, conducting regulatory compliance studies, and eventually reaching human clinical trials. The two main technical areas include developing sensors and synthetic reporters (TA1) and creating an affordable at-home cancer screening kit (TA2), ensuring both components are closely integrated. The proposal emphasizes addressing the increasing cancer burden in the U.S., with a focus on underserved populations. The goal is to improve accessibility, reduce late-stage diagnosis, and manage economic impacts associated with cancer care. Proposers must include multidisciplinary teams and demonstrate a commitment to equitable healthcare representation across demographics. The program's structure incorporates rigorous performance evaluations and requires a comprehensive commercialization plan to ensure developed technologies can be efficiently brought to market, offering affordable solutions for cancer detection nationwide.

The document outlines a Multi-Party Teaming Agreement (MPTA) Letter of Intent (LOI) related to the POSEIDON Project, facilitated by the Advanced Research Projects Agency for Health (ARPA-H). It establishes definitions and terms governing the collaboration among various parties involved in a proposal submitted in response to RFP ARPA-H-SOL-24-109. The MPTA will detail roles, responsibilities, and terms concerning background and foreground intellectual property (IP) vital for commercialization post-project. It specifies the involvement of a commercialization partner to manage the IP and highlights that the executed MPTA will incorporate the terms of the awarded Other Transaction (OT) agreement. All participants are required to sign, affirming their intent to collaborate and house relevant IP within the designated partner, ensuring compliance with government regulations. The document emphasizes the importance of clearly defined IP arrangements to prevent post-award disputes. Overall, it establishes a framework for the POSEIDON project, facilitating the requisite collaboration and resource management essential for successful project execution and commercialization.

The document outlines the structure and requirements for submitting a cost proposal in response to the ARPA-H solicitation ARPA-H-SOL-24-109. It provides detailed guidance for proposers on how to complete the cost proposal spreadsheet, emphasizing that all proposed costs must be justified and fully priced to be eligible for award consideration. Proposers must fill out costs for direct labor, subcontractor services, consultant fees, and other direct costs broken down by each project phase: Phase I, Phase II, and Phase III. Additionally, the proposal must include accounting for general and administrative (G&A) costs, facilities cost of money (COM), and profit or fee considerations, ensuring compliance with government regulations. The spreadsheet contains various tabs intended for data entry—highlighting the importance of clarity in labor rates and justifications for each cost category to facilitate rapid government review and evaluation. This structured approach aims to ensure transparency and thoroughness in financial submissions, underscoring the government's expectation for accountability and reasonableness in cost proposals while enabling efficient processing for potential funding. Overall, the document serves as an essential guide for federal grant applicants and contractors navigating the intricacies of government procurement processes.

The Advanced Research Projects Agency for Health (ARPA-H) issues a Proposers' Day announcement for the POSEIDON Program. POSEIDON aims to develop innovative, at-home cancer detection tests using synthetic biology. The goal is to detect multiple cancer types in their early stages, revolutionizing cancer screening. ARPA-H seeks proposals for the development of sensors and synthetic reporters for urine-based or breath-based tests. These tests must target at least 30 different solid tumor types. The program is structured into two technical areas: Technical Area 1 focuses on sensor and reporter development, while Technical Area 2 covers the design of a low-cost kit for at-home screening, integrating hardware and software components. Proposals can address one or both technical approaches, with ARPA-H encouraging collaboration among academic and commercial entities. The agency envisions a five-year program divided into three phases: discovery and development, IND-enabling studies, and clinical testing. Key information about the Proposers' Day event is provided, including registration details and the program's objectives. Potential proposers are invited to attend to learn more about the funding opportunity and form collaborations.

The provided document outlines a project schedule for a government initiative starting on August 15, 2025. It consists of a Work Breakdown Structure (WBS) detailing various tasks and milestones, denoted by specific labels (Task X, Task Y, and associated milestones M1.1.1, M1.1.2, etc.). Each task is organized across multiple quarters, indicating the projected timeline for each phase and the corresponding phase gate (PG) indicators. The document appears to serve as a planning framework for the project, ensuring delineation between phases and tracking progress through milestones. This structured format is typically employed in federal RFPs and grants to maintain clarity and accountability in project management, ensuring compliance with federal and state stipulations. Overall, the document emphasizes the importance of organization and phase management in government projects to achieve defined objectives within set timelines.

The document outlines a proposal for a project named POSEIDON centered on developing a technology for cancer detection. It emphasizes integrating specific technical approaches (TA1 and TA2) to address selected cancers and outlines a patient care flow from initial use at home through detection scenarios, both with and without identifying cancer. The document highlights potential risks and mitigation strategies, along with a commercial strategy that includes securing partners for funding, manufacturing, and marketing. The proposal also discusses distinguishing features that set their technology apart from competitors, while addressing patient accessibility and maintaining an ideal price point for the product. Additionally, it envisions the overall success of the project, aspirations for future goals, and the company’s direction over the next 5 to 10 years. The importance of the team involved is stressed, showcasing relevant experience, collaborations, and financial considerations, including a rough order of magnitude budget that outlines essential costs. Overall, the proposal is structured to respond effectively to government RFPs and grants, aiming for innovation in cancer detection technology.

The document outlines the tasks and milestones associated with a phased program aimed at addressing various aspects of a project, including technical development, manufacturing, commercialization, regulatory engagement, and accessibility. Each phase consists of distinct tasks, labeled consecutively for clarity, with specific milestones denoting the start and end quarters. The primary focus is on organizing and detailing the necessary steps for successfully advancing through each stage, ensuring that all activities are documented sequentially to facilitate tracking and accountability. This structure is essential for compliance with federal and state RFPs and grant processes, highlighting the program's commitment to transparency and effective resource management throughout its development and execution.

The POSEIDON Solution Summary Submission Aid outlines the requirements for submitting a solution summary regarding cancer detection tests. The document stipulates that submissions must be in English and formatted using specific font and margin guidelines. The solution summary should be two pages long, consisting of a narrative and infographic/preliminary data, and must include a cover page and eligibility certification. The narrative portion must present a clear technical plan for developing tests that identify over 30 cancers through breath and urine samples, alongside a timeline for key deliverables. Furthermore, it requires detailing team organization, including the roles and experiences of key personnel in the project team. An additional section on budget estimation is also required, providing a breakdown of overall project costs and an explanation of cost-sharing if relevant. References are to be included but are not counted in the page limit. The document underscores the importance of adhering to the provided guidelines to ensure a conforming submission to the ARPA-H Solution Submission System, reflecting a focused effort to advance cancer detection methodologies. The overall goal is to promote innovative solutions in cancer diagnosis, emphasizing the urgency and significance of the research endeavors within the healthcare sector.