POSEIDON (Platform Optimizing SynBio for Early Intervention and Detection in ONcology)
ID: ARPA-H-SOL-24-109Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)Bethesda, MD, 208920004, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT (AN13)

Original Source

https://sam.gov/opp/2c5036c43e434d389370c612d7558adc/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health's 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 tests targeting over 30 solid tumors using synthetic biology. The initiative seeks to create user-friendly sensors that utilize breath and urine samples for Stage I cancer detection, with a focus on accessibility for underserved populations to reduce late-stage diagnoses and associated healthcare costs. Proposals will be evaluated based on technical merit, team capabilities, and pricing strategies, with a goal of achieving a retail price of under $100 for the final product. Interested parties must submit their Solution Summaries by November 6, 2024, and can direct inquiries to the POSEIDON Team at POSEIDON@arpa-h.gov.

    Point(s) of Contact
    The POSEIDON Team
    POSEIDON@arpa-h.gov
    Files
    Title
    Posted
    24-SOL-109 POSEIDON DRAFT ISO_9 AUG 24.pdf
    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.
    24-SOL-109 POSEIDON DRAFT ISO.pdf
    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.
    24-SOL-109 POSEIDON ISO_9 SEP.pdf
    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.
    24-SOL-109 POSEIDON ISO_Amend 1_4 NOV.pdf
    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.
    POSEIDON Proposers_Day_Notice.pdf
    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.
    SOLUTION SUMMARY Submission Aid.pdf
    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.
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