Abstract
BackgroundMulti-cancer early detection (MCED) next-generation-sequencing blood tests represent a potential paradigm shift in screening.MethodsWe estimated the impact of screening in the US and UK. We used country-specific parameters for uptake, and test-specific sensitivity and false-positive rates for current screening: breast, colorectal, cervical and lung (US only) cancers. For the MCED test, we used cancer-specific sensitivities by stage. Outcomes included the true-positive:false-positive (TP:FP) ratio; and the cost of diagnostic investigations among screen positives, per cancer detected (Diagcost). Outcomes were estimated for recommended screening only, and then when giving the MCED test to anyone without cancer detected by current screening plus similarly aged adults ineligible for recommended screening.ResultsIn the US, current screening detects an estimated 189,498 breast, cervical, colorectal and lung cancers. An MCED test with 25–100% uptake detects an additional 105,526–422,105 cancers (multiple types). The estimated TP:FP (Diagcost) was 1.43 ($89,042) with current screening but only 1:1.8 ($7060) using an MCED test. For the UK the corresponding estimates were 1:18 (£10,452) for current screening, and 1:1.6 (£2175) using an MCED test.ConclusionsAdding an MCED blood test to recommended screening can potentially be an efficient strategy. Ongoing randomised studies are required for full efficacy and cost-effectiveness evaluations.
Highlights
Multi-cancer early detection (MCED) next-generation-sequencing blood tests represent a potential paradigm shift in screening
The number of cancers detected by current guideline-recommended screening was computed by multiplying the number of cancers covered by each screening type, the adherence to MCED test Screening performance of an MCED blood test was based on an earlier version of the Galleri test, which utilises targeted methylation analysis of circulating cell-free DNA to detect multiple cancer types [14]
Assuming all US colorectal screening is performed with colonoscopy, the TP:FP ratio of current screening is improved to 1:27, but this is still less favourable than the MCED test (1:1.8)
Summary
Multi-cancer early detection (MCED) next-generation-sequencing blood tests represent a potential paradigm shift in screening. We used country-specific parameters for uptake, and testspecific sensitivity and false-positive rates for current screening: breast, colorectal, cervical and lung (US only) cancers. Outcomes were estimated for recommended screening only, and when giving the MCED test to anyone without cancer detected by current screening plus aged adults ineligible for recommended screening. RESULTS: In the US, current screening detects an estimated 189,498 breast, cervical, colorectal and lung cancers. There are currently only four recommended population-level screening programmes: breast, lung, colorectal, and cervical cancers, because of a favourable benefit-harm balance [9] Together, these four cancers represent only 29% of total cancer incidence and 24% of cancer-related deaths in the US among individuals aged 50–79 (Supplemental Fig. 1). There is, as yet, no effective screening test for all other cancer types, and many are unlikely to ever be associated with cost-effective single-cancer screening programmes because they each have relatively low incidence and mortality
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