Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study.

The multi-cancer early detection (MCED) test in the PATHFINDER 2 study achieved a cancer detection rate of 0.54% among participants aged 50 or older, with a CSO prediction accuracy of 91.3%.

• Why it matters: Early cancer detection is crucial for improving survival, but many cancer types lack effective screening methods, creating a need for reliable blood-based tests that can identify multiple cancers early.
• What they did: The study evaluated performance metrics—including cancer detection rate, predictive values, sensitivity, specificity, and CSO prediction accuracy—in over 32,000 participants, alongside safety assessments over 12 months, with no hypothesis testing performed.
• The result: The MCED test demonstrated high negative predictive value (99.2%) and specificity (99.64%), with only 0.6% of participants undergoing invasive procedures after positive results, and no serious adverse events reported, supporting its potential safety and performance in screening populations.