Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study
Deb Schrag1, Tomasz M Beer2, Charles H McDonnell3
1Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Lancet (London, England)
|October 7, 2023
Summary
Multicancer early detection (MCED) blood tests show promise for cancer screening. The PATHFINDER study demonstrated the feasibility of MCED testing, with results guiding diagnostic assessments for participants with a detected cancer signal.
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.
