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1,000 people screened

Galleri study assay (MCED-V2)

PATHFINDER 2 · 35,350 people

Asymptomatic adults aged 50+ at 32 U.S. and Canadian sites; no clinical suspicion of cancer or recent cancer diagnosis/treatment.

Target finding: Cancer diagnosed within 12 months

Each view describes its own study population and definition. These cohorts are not a ranking of screening methods.

1,000 people
The study, scaled to 1,000 peopleReported cohort findings, scaled to 1,000 people. Positive; cancer diagnosed: 4.89 per 1,000; Positive; no cancer diagnosed: 3.22 per 1,000; Positive; follow-up incomplete: 0.51 per 1,000; Negative; cancer diagnosed: 7.55 per 1,000; Negative; no cancer diagnosed: 889.76 per 1,000; Negative; follow-up incomplete: 94.06 per 1,000. Drawing counts are rounded; exact cohort counts are in the table.

One dot ≈ one person. Dots are rounded; exact proportions remain in the labels, including findings smaller than one dot.

A positive result is a signal. A negative result is not a clean bill of health.

From screening to the recorded finding

12-month cancer-status assessment; some participants did not enter the completed-follow-up performance analysis. · Values per 1,000

Positive result8.63
Negative result991.37
Published counts & scaling
PATHFINDER 2 · 35,350 people
Reported categoryStudy countPer 1,000
Positive; cancer diagnosedCancer was diagnosed after a cancer-signal-detected result.1734.89
Positive; no cancer diagnosedNo cancer diagnosis in the completed-follow-up analysis; this is not proof of being cancer-free indefinitely.1143.22
Positive; follow-up incomplete305 total positive results minus 287 positives in the completed-follow-up performance set. Derived by subtraction; not classified as false positive.180.51
Negative; cancer diagnosedCancer was diagnosed within the assessment window despite no signal detected.2677.55
Negative; no cancer diagnosedNo cancer diagnosed in the completed-follow-up analysis; this is not a general healthy status.31,453889.76
Negative; follow-up incomplete35,045 total negative results minus 31,720 negatives in the completed-follow-up performance set. Derived by subtraction; not classified as no cancer.3,32594.06
Total35,3501,000.00

Per-1,000 people values are the source count ÷ cohort size × 1,000, displayed to two decimal places. Dot allocations use largest-remainder rounding, so the drawing has exactly 1,000 dots. Do not infer that a small category was absent from its rounded dot count.

Diagnostic workup

Separate safety population: 35,335 participants, including 290 positive-result participants. These workup counts must not be merged into the grid branches.

Invasive procedures
213 of 290Positive-result participants with at least one invasive procedure; 295 procedures in total.
Diagnostic resolution
48 daysKaplan–Meier median; 95% CI 43–56 days. Fifteen participants did not reach resolution.
When cancer was diagnosed
37 daysMedian; IQR 24–61 days.
When no cancer was diagnosed
70 daysMedian; IQR 38–121 days.
Study context & sources

Asymptomatic adults aged 50+ at 32 U.S. and Canadian sites; no clinical suspicion of cancer or recent cancer diagnosis/treatment.

12-month cancer-status assessment; some participants did not enter the completed-follow-up performance analysis.

Counts show study-cohort experience scaled to 1,000, not a prediction for an individual or the general population.

A cancer diagnosis after a negative blood test can be an interval cancer; these data do not establish that it was already detectable at the blood draw.

Detection and diagnostic performance do not establish a reduction in cancer deaths.

This grid retains all 35,350 analyzable tests; published performance uses 32,007 participants. The 3,343 outside that performance set remain explicitly unclassified.

MCED-V2 was the prospective study assay. Revised-assay retrospective FDA bridging estimates are a different analysis.

Single-arm, sponsor-funded study; diagnostic costs were covered.

The dot grid shows screening findings; it does not by itself establish that screening extends life. A negative result does not establish that a person is healthy. Different cohorts, target definitions and reference assessments cannot be compared as though they were randomized against each other.

Source date: 2026-09-22 · Cohort reference reviewed 2026-10-03