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 ARPA-H-SOL-24-109 solicitation, known as POSEIDON, seeks proposals to develop a Multi-Cancer Early Detection (MCED) platform utilizing synthetic biology for early cancer intervention. The program aims to create affordable, at-home tests capable of detecting over 30 solid tumors using breath and/or urine samples, thereby facilitating early diagnosis when treatment success is highest. Key components include Technical Area 1 (TA1)—development of sensors and synthetic reporters—and Technical Area 2 (TA2)—creation of the screening kit. Performers will operate across three phases: discovery and development, non-clinical testing, and clinical validation. The solicitation emphasizes addressing cancer detection inequities faced by underserved populations, with a commitment to equitable healthcare access. The program aims for rigorous regulatory compliance and seeks to establish a marketable product, ideally priced below $100. Proposals must align with set performance metrics and meet accessibility requirements throughout multiple phases, including regular reporting and engagement with diverse communities. Ultimately, the goal is to significantly reduce the economic burden of late-stage cancer diagnosis and improve overall patient outcomes through innovative screening technologies.

The Multi-Party Teaming Agreement (MPTA) Letter of Intent (LOI) for the POSEIDON Project outlines the collaboration framework between participating entities as they respond to a solicitation from the Advanced Research Projects Agency for Health (ARPA-H). It defines key terms such as Background Intellectual Property (IP), Subject Invention, and Commercialization Partner, and establishes the intention to formalize responsibilities within an MPTA. Team members must sign this LOI to indicate their commitment to contribute significant resources and house relevant IP for products developed under the POSEIDON Program. The LOI asserts that all IP, including both background and foreground creations during the project, will be housed within the designated Commercialization Partner with clear terms to prevent shifts of IP without government consent. As the agreement develops, roles and interactions among team members are specified, ensuring direct governmental communication and guidance. It is emphasized that ARPA-H will not be a direct party in this agreement, placing the onus on the collaborating entities to draft effective teaming agreements. Overall, the document showcases the importance of teamwork in addressing the project requirements while ensuring efficient management of IP rights and complying with the government's procedural expectations.

The document is a detailed cost proposal template for the ARPA-H-SOL-24-109 solicitation, aimed at facilitating the submission of financial proposals by government contractors. It outlines the requirements for cost estimations across multiple phases (Phase I, II, and III) of a project, emphasizing that unpriced options will not be accepted. Contractors need to provide comprehensive supporting data, thereby ensuring the proposal's costs are justifiable and reasonable. The template includes sections for direct labor costs, subproposer costs, consultant fees, other direct costs, material handling, general and administrative expenses, and total budget calculations. Important instructions specify that all financial details must be accurately summarized in alignment with the respective labor categories and phases. The establishment of fiscal years, proposed labor categories, and the breakdown of direct expenses are crucial elements outlined in the structure. Overall, this document serves as a standardized tool designed to streamline the submission process for government contracts, ensuring transparency and accountability in budgeting and cost allocation for projects funded under federal grants or requests for proposals.

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.

This document outlines a project management plan related to government RFPs, including specific milestones and scheduling. The lead organization is initiating a project set to begin on August 15, 2025, and the timeline is divided into various quarters, detailing tasks and milestones necessary for project completion. Key tasks include Task X and Task Y, along with milestones M1.1.1, M1.1.2, M2.1.1, and M2.2.2, indicating significant project phases. Milestones occur in a structured timeframe, emphasizing the importance of a phase gate indicator to monitor progress. The project schedule consists of specific timeframes for task execution, necessary for maintaining accountability and ensuring adherence to federal grant stipulations. The document emphasizes careful project tracking, necessary for compliance within state and local government frameworks, ultimately aiming to adhere to set regulatory standards throughout the project's lifecycle. Overall, the analysis highlights an organized approach toward implementing government-funded projects with a focus on scheduled milestones and progression tracking.

The document outlines a project proposal focused on developing a technology to detect cancer at home. It details the integration of two technical approaches, TA1 and TA2, to meet POSEIDON's objectives and selects additional cancer types for research. The care flow illustrates how the product operates in different scenarios and addresses potential risks, including mitigation plans. The commercial strategy emphasizes fundraising, market entrance, and IP ownership. It also identifies ideal partners for funding and manufacturing. The competitive landscape section highlights the unique aspects of the proposed approach compared to existing technologies. Accessibility features will enhance patient outcomes, while pricing strategies aim to achieve an MSRP of $100 or less. The project vision defines long-term success and future company aspirations over 5-10 years. The team's qualifications and experience are underscored, including any necessary agreements for IP management. Finally, the proposal includes a rough budget overview and key cost factors, ensuring the document adheres to the requirements for government RFPs and grants.

The government file outlines a structured framework for a program divided into several phases, focusing on Technical, Manufacturing, Commercialization, Regulatory Engagement, and Accessibility tasks. Each phase contains specific tasks and milestones that are sequentially numbered to ensure clarity and organization. For instance, Phase I begins with Task 1, comprising two milestones (M1.1 and M1.2) spread across different quarters, followed by Task 2, which includes a third milestone (M2.1). This systematic approach is designed to facilitate project management and accountability throughout implementation. The document serves as a guide for stakeholders involved in federal RFPs and grants, emphasizing the importance of well-defined tasks and outcomes to achieve program objectives efficiently. The overall purpose is to enhance collaboration, ensure compliance, and promote accessibility in project execution, ensuring all critical elements are addressed.

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.