Biden-Harris Administration’s ARPA-H launches program to develop at-home multi-cancer screening test    

Program aims to revolutionize early detection for hard to diagnose cancers 

Today, as part of President Biden’s Unity Agenda and the Biden Cancer Moonshot goal to end cancer as we know it by driving innovation and expanding access to cancer screening, the Advanced Research Projects Agency for Health (ARPA-H) announced the Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON) program. POSEIDON intends to develop first-in-class, at-home, synthetic Multi-Cancer-Early Detection (MCED) tests for the most sensitive and specific stage I detection of 30+ solid tumors* using only breath and/or urine samples. 

Cancer is the second leading cause of death in the U.S. and the leading cause of death for those under 65 years old. Cancer diagnoses for people under 50 have increased by 13% between 2000 and 2019. The National Cancer Institute (NCI) estimates more than two million new cases of cancer diagnoses in 2024, and nearly 60% of diagnosed cancers do not have a recommended screening test. Many MCED tests fail to accurately detect stage 1 solid tumors, which is critical to effectively diagnosing and treating cancers.   

“The field of early cancer screening needs a revolution. Over the next 30 years, more than 40 million Americans are projected to be diagnosed with late-stage cancer, accounting for 44% of all new cancer diagnoses in the U.S. But what if any adult could, at their discretion, take an at-home test that could detect Stage I cancer? POSEIDON aims to create a future in which any adult can take a simple, over-the-counter test to screen for and detect 30+ cancers at Stage I, when they are still localized, to drastically improve the chances of curative treatment and survival,” said Ross Uhrich, DMD, MBA, ARPA-H POSEIDON’s Program Manager. “With a 2-3x increase in treatment costs for late-stage cancer and a projected rise in late-stage diagnoses, the POSEIDON MCED test has the potential to make a significant, lasting contribution to the future of cancer care for all Americans.” 

Through a forthcoming Innovative Solutions Opening (ISO), POSEIDON is approaching multi-cancer early detection across two technical areas. The MCED test device kit must be able to detect 30 different cancers from breath or urine samples, integrate with electronic health records, and be administered at home. The self-administered kit, based on human-centered design, aims to ensure that individuals will connect with a health care professional via a telemedicine call within 96 hours and will receive their results either virtually or in-person at the clinician’s discretion. In cases of a positive result (e.g., presence of cancer), patients will be connected to the nearest medical center for an official diagnostic work-up and continued care.  

“So many Americans do not have access to cancer screening, particularly underserved communities. Access to a low-cost cancer screening test that does not need a lab test is so critical to preventing late-stage diagnoses, increasing survival rates, and reducing high treatment costs,” said ARPA-H Director Renee Wegrzyn, Ph.D. “With POSEIDON, we could put the power of cancer screening into homes in the U.S. and around the world.” 

Additionally, ARPA-H’s POSEIDON program executed a memorandum of understanding, or MOU with the NCI for access to NCI’s Cancer Screening Research Network (CSRN). The MOU provides a path for future collaboration between POSEIDON performers and the CSRN. 

“People at higher risk for cancer need to understand their likelihood of developing the disease and the possibility of detecting it early if it occurs,” said NCI Director Dr. W. Kimryn Rathmell. “Rapidly advancing technologies, including these, present exciting opportunities to advance clinical research and make progress against cancer.” 

Uhrich added, “Moonshots do not occur in a vacuum. Particularly for oncology, cross-governmental collaboration is essential. Now, through a brand-new partnership with the NCI’s Cancer Screening Research Network (CSRN), teams that successfully complete POSEIDON can enter into the CSRN for further clinical trials. Together, we can drastically change the future of cancer care for the better.”   

Multiple awards under this ISO are anticipated. Awards will depend on the quality of the proposals received and the availability of funds. Learn more about POSEIDON on its program page, including information about the Special Notice, Proposers’ Day registration, and guidance on how to submit a teaming profile. 

*Cancer list (25 required by the program, ≥5 selected by performers) listed in POSEIDON ISO