Commercially available blood test for multiple cancers lack evidence of accuracy, benefits and harms

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US scientists say there's a lack of evidence around the accuracy, benefits and potential harms of commercially available blood tests that claim to be able to detect many different types of cancer (multicancer detection [MCD] tests). They looked back at the existing research on these conducted between 2013 and 2024, and found that no properly-conducted studies reporting benefits of MCD test screening have been completed, and there isn't enough evidence to assess harms and accuracy. They say that, despite this, some tests are already commercially available. The scientists conclude that these gaps in our knowledge about MCDs should be filled by further studies looking at deaths from specific cancers following testing, the benefits and harms of the tests for different populations, cost effectiveness, the best timing for screening, and communicating the benefits and risks of MCD tests to doctors and patients.

Media release

From: American College of Physicians

Despite commercial availability, evidence of benefits, accuracy, and harms of multicancer detection tests is unclear

A systematic review assessed the benefits, accuracy, and harms of screening with blood-based multicancer detection (MCD) tests in asymptomatic adults. The review revealed that no controlled studies that report benefits of MCD test screening have been completed, and there was insufficient evidence to evaluate harms and accuracy. The findings can inform focus areas for additional research on MCD tests. The review is published in Annals of Internal Medicine.

Researchers from RTI–University of North Carolina Evidence-Based Practice Center and The Ohio State University College of Medicine aimed to review and analyze controlled studies of MCD tests in asymptomatic populations reporting cancer detection, mortality, quality of life, and harms (psychosocial, adverse events, decrease in standard-of-care screening); uncontrolled studies for harms of diagnostic evaluation; and test accuracy studies completed between 1 January 2013 and 26 December 2024. The researchers did not identify any completed controlled studies of MCD tests for screening. For test accuracy, the researchers included 20 unique studies reporting on 19 unique MCD tests. They found that accuracy varied widely based on study design, type of cancer the MCD test was designed to report, and subgroups of participants. One controlled study reported on one harm of screening outcome and two harms of diagnostic evaluation outcomes; however; the strength of the evidence reported was deemed insufficient due primarily to study limitations and unknown or inconsistent findings. Despite limited or insufficient evidence to support the widespread adoption of MCD tests, some tests are commercially available. To address gaps in knowledge, the reviewers say future research should include empirical studies on 1) surrogate outcomes for cancer-specific mortality, 2) benefits and harms of MCD tests in various populations, 3) harms and cost-effectiveness, 4) the optimal timing of use and intervals for rescreening, and 5) communicating benefits and risks for screening with MCD tests to clinicians and patients. Results from this review can inform clinical and policy decision making by clinicians, medical professional organizations, guideline developers, health care payers, and other groups or organizations.

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Annals of Internal Medicine
Research: Link to Paper 1 | Paper 2
Organisation/s: RTI International, USA
Funder: Agency for Healthcare Research and Quality. (PROSPERO: CRD42024570793)
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