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Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study.

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Area of Science:

  • Oncology
  • Genomics
  • Clinical Trials

Background:

  • Multicancer early detection (MCED) blood tests analyze circulating cell-free DNA (cfDNA) to detect cancer signals.
  • The PATHFINDER study was designed to assess the feasibility of using MCED tests for cancer screening in a real-world setting.

Purpose of the Study:

  • To investigate the feasibility of multicancer early detection (MCED) blood testing for cancer screening.
  • To evaluate the diagnostic pathway and time to resolution following a positive MCED test result.

Main Methods:

  • A prospective cohort study involving adults aged 50+ without cancer symptoms across seven US health networks.
  • Participants underwent MCED blood testing; positive results, indicating a cancer signal, guided subsequent diagnostic evaluations.
  • Circulating cell-free DNA (cfDNA) methylation signatures were analyzed to predict cancer signal origin.

Main Results:

  • A cancer signal was detected in 1.4% of 6621 participants with analysable results.
  • Of those with a detected signal, 38% were diagnosed with cancer (true positives) and 62% were not (false positives).
  • Median time to diagnostic resolution was 79 days, with fewer procedures and surgeries in false-positive cases compared to true positives.

Conclusions:

  • The study supports the feasibility of implementing multicancer early detection (MCED) blood tests in cancer screening protocols.
  • Further research is warranted to fully establish the clinical utility and impact of MCED testing on patient outcomes.