INSIGHT BANK · 28 LIVING CARDS
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Evidence, technologies, people and the next test—connected, but not confused.
Commercializationv4 · 09.23
How far will broader coverage translate into new screening and diagnostic follow-up?
Guardant announced Shield’s inclusion in EviCore guidelines, effective January 1, 2027. This is not an update to detection performance.
- ✓Policy announcementRecorded
- ◷January 2027 implementationScheduled
- ?Testing and paymentUnverified
- ?Follow-up colonoscopyUnverified
Additional source checkedAdded planned EviCore implementation; prior clinical-performance assessment is unchanged.
NEXT CHECKTrack implementation, tests and payments, participation by previously unscreened people, and completed follow-up colonoscopies separately.
Commercializationv3 · 09.07
Where might linked diagnostic and therapy approvals stall in practice?
Concurrent approvals. Uptake and payment for the new use remain open.
- ✓Drug & CDxRecorded
- ?UptakeUnverified
- ?PaymentUnverified
- ?Real-world useUnverified
Analysis addedAdded a short reading on treatment-switch timing, ongoing monitoring and the practical and payment conditions for adoption.
NEXT CHECKConfirmatory trials, payer policies for the new use and clinical uptake.
Commercializationv1 · 10.13
What benefit comes from detecting a resistance mutation and switching treatment before radiographic progression?
European certification was added for Guardant360 CDx. Earlier switching prolonged PFS in selected SERENA-6 patients, while SERENA-4 under different conditions missed its primary endpoint. FDA requires confirmation comparing early switching with switching at progression.
- ✓PFS benefit in selected patientsRecorded
- ?Compare early and progression-time switchingUnverified
- ?Long-term benefit and uptakeUnverified
New question openedLinked European CDx certification, SERENA-6, SERENA-4 and FDA confirmation requirements through the question of treatment timing.
NEXT CHECKComparison of early and post-progression use of the same drug, longer-term survival and uptake in the indicated population.