Market Intelligence
Clinical Pull Index
Which precision Dx assays appear in active clinical trials — and what share of those trials are interventional (the assay embedded in a treatment protocol) rather than observational.
Counting trials is easy. But a trial that studies an assay is fundamentally different from a trial that uses an assay to decide whether a patient gets chemotherapy, escalates treatment, or avoids surgery. The second type is clinical pull. The first is still making the case.
The closest registry proxy: interventional-study share — the percentage of recruiting studies ClinicalTrials.gov classifies as interventional rather than observational. It signals the assay sits inside an intervention protocol, a step beyond pure observation — but, as Galleri shows below, it does not by itself prove the result directs treatment. Read with trial count and the named pivotal trials, it maps which assays are crossing from “researched” toward “used.”
This is not a perfect metric — and Guardant360 is the clearest illustration of why. Guardant360 has zero interventional trials in this index, yet it is the undisputed commercial leader in liquid biopsy for therapy selection. (Guardant’s MRD position runs through a separate product — Guardant Reveal, listed above — not Guardant360.) The reason it shows zero: Guardant360 achieved clinical adoption primarily through FDA companion diagnostic approvals embedded in pharma drug trials — where the assay is listed under the drug, not as an independent intervention — and through direct oncologist adoption in standard care. We verified this is not a registry gap: Guardant360 has no completed or active interventional trials on ClinicalTrials.gov under that name. It is a different, and arguably faster, path to clinical pull.
The clinical pull matrix
X-axis: number of recruiting trials. Y-axis: share classified as interventional study type (the assay sits in an intervention protocol — not proof it directs treatment). Bubble size = company revenue. Upper-right = the most trial activity with the assay embedded in interventions.
The Galleri anomaly. Galleri shows 100% interventional — but none of its trials use the test to change treatment. They test whether offering Galleri affects screening behavior and outcomes. Interventional label ≠ treatment-directing. Signatera and Oncotype DX, by contrast, appear in trials where a positive result literally determines whether chemotherapy is given. That is the distinction.
| Assay | Total trials | Enrolled |
|---|---|---|
1 Signatera Natera | 13 | 3.9k |
2 FoundationOne CDx Foundation Medicine / Roche | 9 | 11.1k |
3 Decipher Prostate Veracyte | 9 | 3.5k |
4 Oncotype DX Exact Sciences | 8 | 8.4k |
5 Galleri GRAIL | 4 | 53.5k Enrollment dominated by REACH study (50k patients) |
6 Prosigna Veracyte | 2 | 2.1k |
7 Guardant Reveal Guardant Health | 1 | 2.0k |
8 Guardant360 Guardant Health | 1 | 470 Likely undercounts — many Guardant trials use generic ctDNA language |
9 AlloSure CareDx | 1 | 27 |
What this tells us
Oncotype DX is the most clinically embedded assay in this dataset. Three pivotal Phase 3 trials, two of which are NRG Oncology cooperative group studies running at 800+ and 1,200+ sites respectively (now closed to enrollment, so they fall outside the recruiting count in the table above). It has crossed the threshold from “assay used in trials” to “assay that defines the trial design.” That is what standard of care looks like in clinical research.
Signatera is the fastest-moving newer entrant. Its pivotal Phase 3 trial — NRG Oncology, 1,912 patients, 1,061 sites (also closed to enrollment) — signals that the field has accepted Signatera as the reference MRD assay for colon cancer adjuvant treatment decisions. No other ctDNA-based MRD assay has reached that validation tier yet.
FoundationOne CDx has the broadest pharma sponsor penetration. Its interventional trials include a Roche Phase 3 with 352 sites — an assay embedded in its own parent company’s drug development pipeline, which virtually guarantees continued clinical trial volume regardless of market conditions.
Methodology: Counts reflect recruiting trials on ClinicalTrials.gov listing each assay by name in the intervention field. Interventional-study share = the percentage of those recruiting trials classified by ClinicalTrials.gov as interventional (vs. observational); it signals the assay appears within an intervention protocol but does not by itself prove the result directs treatment — see the Galleri note above. The “Recruiting Ph 3” column counts only currently-recruiting Phase 3 trials (phase list containing Phase 3, so combined Phase 2/3 trials are captured); several pivotal Phase 3 trials discussed above — the NRG cooperative-group studies for Oncotype DX and Signatera — have closed enrollment and so do not appear in that live count. Named-trial details (site counts, enrollment) are editorial and current as of last review. Enrollment sums reported participant counts across up to 100 trials. Data refreshes daily. Last updated: June 18, 2026.