Minimal residual disease, multi-cancer early detection, treatment response monitoring, and comprehensive genomic profiling get pitched as one category because they share a blood draw. They don't share an evidence bar, a payer conversation, or a competitive set. We use a four-category taxonomy — adapted from the open-data category work at OpenOnco — to keep commercial strategy honest about which job a given test is actually doing.
Comprehensive genomic profiling sits on twenty years of tissue-liquid concordance data. MCED is asking a mortality-reduction question that won't have a clean answer for years. Positioning a test as if it sits somewhere it doesn't — in either direction — is the fastest way to lose a payer or a KOL relationship you'll need again.
What actionable alterations does this tumor carry right now? The most established category, closest to commodity.
After curative-intent treatment, is there detectable disease left — and should adjuvant therapy escalate or de-escalate?
Is ctDNA clearing, plateauing, or rising on therapy — before imaging would show it?
Is there a cancer signal in an asymptomatic person, and where did it originate? The earliest-stage, longest-runway category.
Same underlying chemistry, four different conversations with payers and guideline bodies. The commercial mistake is treating them as interchangeable.
Evidence stage: established, validated against tissue NGS across multi-year, real-world data sets.
Reimbursement: broadest of the four — Medicare LCDs and most commercial payers cover liquid CGP for advanced solid tumors.
Commercial angle: differentiate on turnaround time, tissue-liquid concordance, and panel breadth — not on proving the use case exists.
Evidence stage: fast-moving, the most active prospective trials reading out right now across colorectal, breast, and lung.
Reimbursement: fastest-growing story in liquid biopsy — Medicare and major payers have moved in several tumor types within two years.
Commercial angle: build the motion around named trial readouts and guideline-inclusion timing — not general awareness.
Evidence stage: maturing, strong retrospective correlation with survival but fewer prospective trials tying a ctDNA-triggered switch to benefit.
Reimbursement: inconsistent — covered in some indications through companion diagnostic pathways, out-of-pocket or trial-embedded in most others.
Commercial angle: separate "tracks with outcome" from "acting on this changes outcome." Payers are asking the second question.
Evidence stage: earliest, screening-population sensitivity and specificity data exists but mortality-reduction data is still years out.
Reimbursement: essentially none at scale — out-of-pocket today, with USPSTF and guideline-body decisions as the gating event.
Commercial angle: the longest runway and highest ceiling. Overselling the evidence bar to a payer or KOL costs credibility on the next conversation.
One question gets you most of the way there. Select the population your test is designed for — not every population it could theoretically serve.
A commercial translation model for diagnostics platforms building payer and KOL strategy against the right bar for their category — not the one next door.