LAUSR

BRIEF BACKGROUND Cancer is the second leading cause of death in the United States, with approximately 1,800,000 new cancer cases and more than 600,000 deaths expected in 2020. In the coming decades, cancer is expected to become the leading cause of death worldwide because mortality from cardiovascular disease is on the decline. Approximately $200 billion per year is spent providing cancer care in the United States alone, mostly to treat latestage disease. As an innovative society, it behooves us to address this type of disease burden. Rapid developments in science and technology in cancer prevention and, more specifically, in the early cancer detection space provide a window of opportunity to develop populationlevel interventions that address this cancer burden. Advances in the treatment of cancer, such as immunotherapy and targeted therapies, have led to a modest improvement for patients with cancer, with a median survival improvement of approximately 3 months, but the problem remains that >70% of cancers are detected at a late stage (based on US data, in which early/localized tumors include invasive, localized tumors that have not spread beyond organ of origin, and late/metastasized tumors include invasive cancers that have metastasized beyond the organ of origin to other parts of the body). In addition, treatment for metastatic cancer can be less effective and can be up to 2 times more costly than treatment for nonmetastatic cancer. To date, most of the innovation has come in later stage disease management, promoted by an overarching paradigm of incentivization for latestage drug development. Although patients continue to need this type of innovation, we are at an inflection point where the focus on early detection of disease has the potential to significantly improve cancer outcomes by intervening at an earlier stage. Indeed, the best way to make a populationlevel impact on cancer is through early detection, when the maximum amount of actionability is possible. Screening and prevention programs for cancer have already shown benefits, with the most well established recommendations for colorectal, breast, cervical, and lung cancer screening. The current paradigm revolves around singleorgan screening tests, which target 1 organ at a time using differing interrogation modalities. Singleorgan cancer screening can effectively save lives, as has been demonstrated in patients for whom there are screening programs. Singleorgan cancer screening is credited with asymptomatic detection of approximately 17% of cancers annually, which is a remarkable achievement when considering the poor incentives and lack of infrastructure supporting technologies for early detection application (calculated from Surveillance, Epidemiology, and End Results 18 registries research data: of approximately 1.2M new cancer diagnoses, approximately 0.50M were in cancers with a US Preventive Services Task Force [USPSTF] rating of A, B, or C [breast, cervix, colorectal, lung, and prostate cancers] and, of those, approximately 0.20M were diagnosed using current recommended screening methods: [0.20M]/[1.2M] = approximately 17%). Despite the progress made by singleorgan screening innovations, there is still a great unmet need to increase that cancer detection rate because >70% of cancer deaths occur among cancers that do not have recommended screening; this assumes that USPSTFrecommended screening is available for all prostate, breast, cervical, and colorectal cancer cases, and for 33% of lung cancer cases based on the estimated proportion of lung cancers that occur in screeneligible individuals older than 40 years. It is wellrecognized that improved early cancer detection may