The Advanced Research Projects Agency for Health (ARPA-H) has issued a Request for Proposals (RFP) for the POSEIDON program, a groundbreaking initiative aimed at advancing cancer screening technologies. The Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON) seeks to develop innovative, non-invasive tests that can detect multiple cancers at an early stage using synthetic biology. Here is everything potential proposers need to know to participate in this transformative opportunity.
Overview of POSEIDON Program
POSEIDON envisions a future where cancer can be detected early from simple at-home tests, significantly increasing the chances of effective treatment and survival. The program is divided into two main technical areas:
- Technical Area 1 (TA1) – Sensor and Synthetic Reporter Development:
- Objective: Develop innovative sensors and synthetic reporters that can detect molecular signatures indicative of early-stage cancers through non-invasive samples like breath and urine.
- Focus: Utilize synthetic biology to create highly sensitive and specific biosensors capable of identifying over 30 different solid tumor types at stage I. These biosensors will be designed to react to specific cancer biomarkers and release detectable signals in non-invasive samples.
- Challenges: Achieving high sensitivity and specificity, ensuring stable and safe sensor operation within the human body, and integrating these sensors into a user-friendly format for at-home testing.
- Technical Area 2 (TA2) – Cancer Screening Kit Development:
- Objective: Develop a low-cost, easy-to-use at-home cancer screening kit that integrates the synthetic biology sensors from TA1.
- Focus: The kit will provide all necessary components for the patient to perform the test independently without professional assistance. It includes sample collection tools, a detection device, and digital connectivity for immediate analysis and feedback via integrated health records.
- Challenges: Ensuring the kit’s user interface is intuitive, maintaining the integrity of biological samples during collection and analysis, and ensuring data privacy and security in digital communications.
RFP Details and Proposal Requirements
Companies and consortia interested in submitting proposals must address comprehensive technical solutions, program metrics compliance, and demonstrate a clear path to commercialization and regulatory approval. Proposals should cover:
- Technical Solution and Innovation: Detailed description of sensor technologies and device kits, ensuring high sensitivity and specificity.
- Compliance with Program Metrics: Outline strategies to meet or exceed the performance metrics set out for both technical areas.
- Regulatory and Commercial Pathway: A roadmap for regulatory engagement, commercialization, and market entry strategies.
- Accessibility and Equity: Plans to ensure the product is affordable and accessible across various demographics, including underserved populations.
- Team Expertise: Information on the project team, including qualifications and roles, to ensure project success.
Program Structure and Key Phases
The program is structured into three sequential phases, each with specific goals and milestones:
- Phase 1 (Discovery and Development): Focuses on the development and preclinical validation of sensors.
- Phase 2 (Regulatory and Preclinical Studies): Covers IND-enabling studies and preparation for clinical trials.
- Phase 3 (Clinical Trials): Involves first-in-human testing to assess safety and efficacy.
Key Dates and Submission Details
- Proposers’ Day: September 4, 2024, from 8:30 AM to 5:00 PM ET (participation optional, with materials posted on SAM.gov)
- Questions & Answers Deadline: September 24, 2024
- Priority Submission Date: October 16, 2024
- Final Submission Deadline: November 6, 2024
- Full Proposal Due Date: Expected by January 8, 2025
The POSEIDON program by ARPA-H is a pivotal opportunity for forward-thinking organizations to impact the future of oncology by pioneering the next generation of cancer screening technologies. This initiative not only promises to enhance cancer detection and treatment but also to make advanced screening tools widely accessible, ultimately saving countless lives through early intervention.
If your company has considered applying for ARPA-H funding, your federal funding journey starts here.
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