Gilberto Lopes: Judge MCED by The Evidence, Not The Testimonial
Gilberto de lima Lopes Junior/primeinc.org

Gilberto Lopes: Judge MCED by The Evidence, Not The Testimonial

Gilberto Lopes, Chief of the Division of Medical Oncology at the Sylvester Comprehensive Cancer Center, shared a post on X:

MCED testing is having its moment at ASCO 2026, and it’s a useful lesson in the evidence ladder. Three abstracts, three very different rungs – and they shouldn’t be read as equivalent.

Top rung: NHS-Galleri (LBA100, Swanton et al) – the first and only RCT of an MCED test, 142,000+ participants. Feb press release: substantial drop in stage IV diagnoses, more stage I/II detection, ~4x cancer detection rate. The honest asterisk: higher-than-expected stage III incidence. Mortality data still maturing.

Middle rung: PATHFINDER 2 (LBA10509) – registrational, intended-use safety and performance. The dataset built to support regulatory approval.

Then the bottom rung, and the one to read carefully: Sue et al (Abstr 10532), a single private-practice network’s implementation experience.

What the real world evidence abstracts can’t tell you: The private practice experience (10532) is single-arm, n=1,949, 20 signal-positives. “100% CSO accuracy” is 7/7 – CIs near-uninformative. With no control and no capture of cancers among the ~1,925 who tested negative, it structurally can’t report sensitivity, specificity, or false-positive burden.

What it legitimately CAN teach: implementation. 69.6% of eligible pts took ≥2 tests, mostly annual; repeat-testing after inconclusive workup behaved sensibly (4/5 cleared on neg retest). Adoption and longitudinal uptake in primary care is exactly what a real-world series should contribute.

The line that ties all three together: none of the screen-detected cancers had a USPSTF A/B pathway. That’s the real MCED thesis – finding lethal cancers with no other screening route. NHS-Galleri tests whether that changes outcomes at population scale. The case series just shows people will use it.

One more Real-world ASCO 2026 data (Ghosh et al, Mayo): enterprise-wide MCED (Galleri) testing across 3 sites, 7,300 pts. PPV 58.7% (32/57 positives) – believable precisely because it’s denominator-anchored, not a small-n 100%. But the quiet stat matters most: 5.2% of test-NEGATIVE pts still got a cancer dx. A negative is not an all-clear.

Bottom line: judge MCED by the evidence, not the testimonial. Implementation data answer ‘will clinics adopt it?’; only NHS-Galleri answers ‘does it help?’ Both matter – but don’t let a 7/7 accuracy headline from an uncontrolled series stand next to a 142,000-pt randomized trial. Different questions, different weight.”

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