You staged it correctly.

TNM didn’t tell you everything.

When you call a resected non-squamous NSCLC tumor “stage I,” you are right by every criterion the TNM system gives you: the margins, the nodes, the size, the histology. Your diagnosis is accurate.

But for 30–45% of those patients, the biology is already ahead of the pathology. Occult micrometastatic cells are beyond conventional staging and undetectable by imaging. But the tumor harbors mRNA expression patterns that have been rigorously validated to assess a high risk of recurrence and death within five years. RiskReveal gives you the gene expression profile of the tumor to support an accurate prognosis.

TNM staging answers: “How far has it spread?” Molecular risk stratification answers: “Is it likely to have spread, undetected?”

These are two different questions. Now pathology can answer both.

The Limitation Isn’t Your Diagnosis, It’s the Staging System

Unlike most solid tumors, early-stage lung cancer carries a 30–45% five-year rate of recurrence and/or death even after complete resection. That number reflects the fundamental gap between anatomic staging and molecular biology rather than a failure of the diagnostic process.

A meaningful subset of your stage I patients are, in molecular terms, understaged. Their nodal or distant spread has not yet been detected. Their tumor size fits the IA or IB criteria. They look like surgical cures. They are not.

Until now, there was no standardized tool to identify these patients at the time of pathologic diagnosis that provided randomized confirmation of predictive efficacy. RiskReveal integrates directly into the pathology workflow, is applied to the same FFPE tissue block you already process, and delivers validated, predictive molecular risk classification alongside your pathology report.

The result is a complete diagnostic picture that gives the surgeon and the medical oncologist what they need to act.

Workflow Fit

How RiskReveal Works

RiskReveal is a 14-gene mRNA expression assay applied to FFPE tumor tissue from resected non-squamous NSCLC. It classifies patients as molecular high- or low-risk for recurrence and death, independent of TNM stage, tumor size, and EGFR mutation status. Its most important difference is its extensive prognostic validation and now its predictive validation based on the only prospective randomized study to demonstrate the benefit of adjuvant therapy even for patients with TNM stage IA disease.

Specimen

FFPE tissue block or slides

Turnaround

≤ 10 business days from receipt

Shipping

Kit provided by Razor Genomics

The assay integrates into your existing workflow with no additional tissue collection or sample preparation beyond standard processing.

The Evidence

The Science Behind the Assay

Lancet 2012 — Original Validation

JAMA 2012 — Subgroup Analysis: T1aN0 Patients

UCSF Prospective Study 2021 — First Clinical Evidence for Treatment Guidance

Lancet Respiratory Medicine 2025 -- AIM-HIGH Phase 3 Randomized Trial

Lancet 2012 — Original Validation

JAMA 2012 — Subgroup Analysis: T1aN0 Patients

UCSF Prospective Study 2021 — First Clinical Evidence for Treatment Guidance

A prospective non-randomized, single-center study of 250 patients at UCSF directly tested whether molecular risk stratification could guide adjuvant chemotherapy decisions. Patients were classified by both molecular risk and NCCN criteria. Treatment decisions were made by patients and their oncologists.

5-Year Disease Free Survival by Risk Classification5-Year Disease Free Survival by Risk Classification

Classification	Low-Risk (untreated)	High-Risk (untreated)	High-Risk (treated)	p
Molecular (RiskReveal)	94.6%	72.4%	97.0%	<0.001

Molecular risk stratification was statistically significant in predicting treatment benefit. High-risk patients who received chemotherapy based on molecular classification achieved DFS nearly identical to low-risk patients: 97.0% (high-risk, treated) vs. 94.6% (low-risk, untreated), vs. 72.4% for high-risk, untreated.

Lancet Respiratory Medicine 2025 -- AIM-HIGH Phase 3 Randomized Trial

AIM-HIGH is the Phase 3 randomized, multicenter, international confirmation of the predictions contained in the validation and earlier prospective studies. Across 45 sites in the US and Europe, molecularly high-risk stage IA–IIA non-squamous NSCLC patients were randomized to adjuvant platinum-doublet chemotherapy or resection alone.

Key Outcomes

Population	Treated DFS (24-mo)	Untreated DFS (24-mo)	Risk Reduction
High-risk stage IA–IIA	96%	79%	78% (HR 0.22)
High-risk stage IA only	98%	78%	85% (HR 0.15)

Molecular risk was independent of EGFR mutation status. Chemotherapy-related mortality was 1%.

On timing:

All recurrences in the treated arm occurred when chemotherapy was initiated more than 3.5 months post-diagnosis. Pathology-integrated ordering at the time of resection diagnosis maintains your normal reporting workflow and keeps the patient well within the actionable treatment window.

RiskReveal vs. Blood-Based MRD Testing

Some oncologists are evaluating ctDNA as a post-resection prognostic tool. The evidence base, relative to RiskReveal, warrants direct comparison.

	RiskReveal / AIM-HIGH	Clinically Available Blood-Based MRD (ctDNA)
Type of data available	Phase 3, randomized, interventional	Observational, no intervention
Sites per study	45 (US + Europe)	Single center
Number of high-risk stage I patients with outcomes included per study	190	<20
Published	Lancet Respiratory Medicine, 2025	J Thoracic & Cardiovascular Surgery, 2024; J Thoracic Oncology, 2026
Time to actionable assay result	<10 days	2-3 months or greater

Blood-based MRD testing retains clinical utility for post-treatment recurrence surveillance. As a pre-treatment prognostic decision tool for early-stage NSCLC, it lacks outcomes data and introduces a delay that is incompatible with the best standard of care adjuvant treatment window.

Your Role in the Complete Diagnostic Picture

The pathology report is the clinical team’s foundation. When those reports include a RiskReveal molecular risk classification, medical oncologists have what they need to make a scientifically-based, treatment decision based on randomized predictive data without delay, without ambiguity, and without sending the patient back for additional workup. Ordering RiskReveal as part of your standard workflow for resected stage I non-squamous NSCLC doesn’t change your diagnosis. It completes it.

You identified the stage. RiskReveal identifies the risk. Together, the clinical team can act.

Ordering & Logistics

Sample Requirements

FFPE tissue block or slides. Razor Genomics provides a shipping kit with preparation and shipping instructions.

Turnaround Time

Results available within 10 business days of specimen receipt, generally sooner.

Order the Test

Insurance Coverage & Resources

Insurance & Patient Access

Razor Genomics accepts many forms of insurance. Patients with Medicare have no out-of-pocket cost. For patients with other insurance, Razor Genomics bills directly — coverage depends on the specific plan.

Patient Assistance Program are available.

Billing questions:

Billing: 1-844-662-6298

Secure Fax: (949) 271-5753

For Your Colleagues

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