How do you know your operation actually cured your early-stage lung cancer patient?

Roughly 1 in 3 of your stage I NSCLC patients will recur, usually at a distant site. The surgery did not fail; the biology was already ahead of you.

Occult micrometastasis drives recurrence in 30–45% of resected stage I non-squamous NSCLC patients. Until now, there was no clinically validated way to identify which patients harbored that risk before it manifested, or which patients would benefit from adjuvant therapy.

No longer. RiskReveal has changed that.

Results from the Prospective Randomized AIM-HIGH Clinical Trial:

79%

Untreated High-Risk

DFS

96%

Treated High-Risk

DFS

78%

Risk Reduction

(HR 0.22)

The Lancet Respiratory Medicine, 2025

There is now randomized predictive evidence that will allow your oncology colleagues to provide potentially life-saving adjuvant therapy to your Molecular High-Risk patients identified with 14-gene, RiskReveal expression profiling, even in stage IA.

The Problem

TNM Stage I Isn’t One Patient Population

TNM staging tells you what imaging and pathology can see. What matters, however, is the biological state a tumor has already reached at the time of resection. Only reviewing the molecular biology of the tumor can tell you that.

A subset of your stage I-IIA patients have tumors with a high-risk molecular biology profile and face a high recurrence risk, reminiscent of stage IIB or higher. It is no great surprise that they have now been documented in a multi-institution, international, prospective, randomized clinical trial to respond to the same adjuvant chemotherapy as stages IIB-III. Now that their benefit has been documented, there is no justification to withhold potentially life-saving intervention.

Oncologists have historically relied upon outdated, now obsolete studies to maintain their belief that stage IA patients and stage IB patients with tumors <4 cm do not benefit from adjuvant intervention. One of the primary handicaps of those 20-year-old studies was that patients cured by surgery alone diluted any benefit that could have been observed with adjuvant chemotherapy. Recently published, modern data that include molecular risk stratification have now clearly demonstrated that molecular high-risk patients derive substantial benefit from adjuvant therapy even in stage IA, and therefore must be identified and treated in order to prevent thousands of unnecessary deaths in the US alone.

The Evidence

AIM-HIGH Phase 3 Randomized Trial

Published in The Lancet Respiratory Medicine, 2025

AIM-HIGH is the first Phase 3 randomized clinical trial to demonstrate a benefit from adjuvant therapy throughout stages IA-IIA NSCLC. That dramatic benefit, even in stage IA, was achieved by applying RiskReveal 14-gene molecular risk stratification to identify high-risk stage IA–IIA non-squamous NSCLC patients.

The trial enrolled 449 patients across 45 sites in the US and Europe. High-risk patients were randomized to 4 cycles of platinum-based doublet chemotherapy plus local standard of care, vs. resection alone. The primary endpoint was Disease Free Survival (DFS).

Key Outcomes

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

What this means clinically

A note on timing

What this means clinically

A note on timing

RiskReveal vs. Blood-Based MRD Testing

Some practices are exploring circulating tumor DNA (ctDNA) as a post-resection prognostic tool. However, blood-based MRD testing has never been assessed in a randomized study of early post-operative intervention. The approach retains utility for long-term recurrence surveillance. However, there is no evidence for its utility as a pre-treatment prognostic tool to help with adjuvant therapy decision making for early-stage NSCLC. Any attempt to use MRD for this purpose, which notably lacks predictive utility data, entails a delay to actionable results that renders it impractical within the most effective adjuvant chemotherapy window.

What RiskReveal Gives You — and Your Patients

For high-risk patients:

A validated, randomized trial-backed method to initiate adjuvant chemotherapy consistent with NCCN guidelines for early-stage disease in which an unacceptable risk of recurrence and mortality is hidden by conventional TNM staging.

For low-risk patients:

Evidence-based reassurance. The conversation shifts from “we think you’re cured” to “your tumor biology confirms you’re low risk.”

Make sure every high-risk patient is identified and treated. Give every low-risk patient peace of mind.

Workflow Integration: When and How to Order

RiskReveal is most effectively integrated at two points in the surgical care pathway:

Point 1: Pre-Operative Discussion

This is the ideal time to introduce patients to the full breadth of modern integration of molecular technology into the management of early-stage NSCLC. Avoid a sudden, disconcerting introduction of the high-risk of recurrence during the post-operative period by explaining up front that although surgery is intended to be the cure, some tumors harbor a high-risk molecular biology. The risk of recurrence can now be dramatically lowered by taking a two-stage approach when necessary: gold-standard surgery followed by molecular analysis of the resected tumor and a short course of well-tolerated post-operative chemotherapy when necessary for high-risk tumors to raise survival rates from the 60s to 70s into the high 90s.

Point 2: First Post-Operative Visit

At the first postoperative visit, remind or inform the patient that you would like to send the tumor out for molecular review to assess the tumor’s actual risk or recurrence, which cannot be determined either during surgery or on a pre- or post-op scan.

Ordering & Logistics

Perform
resection

During the first post-op
appointment remind your
patient about RiskReveal
and order the test
Download Order Form

Low-risk

High-risk

Discuss results
Learn More

Routine
follow up

Refer to a medical oncologist

Perform
resection

During the first post-op appointment remind your patient about RiskReveal and order the test
Download Order Form

Low-risk

Discuss results
Learn More

Routine
follow up

High-risk

Discuss results
Learn More

Refer to a
medical
oncologist

Sample Requirements

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

Turnaround Time

Results typically guaranteed within 7-10 days of specimen receipt, often available 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.

RiskReveal is approved for any patient that meets the following criteria.

Questions about insurance or billing:

Billing: 1-844-662-6298

Secure Fax: (949) 271-5753

For Your Colleagues

Shareable with tumor board, oncology partners, and referring physicians.

Surgeons

Medical Oncologists

Pathologists

Nurse Navigators

How do you know your operation actually cured your early-stage lung cancer patient?

Roughly 1 in 3 of your stage I NSCLC patients will recur, usually at a distant site. The surgery did not fail; the biology was already ahead of you.

No longer. RiskReveal has changed that.

Results from the Prospective Randomized AIM-HIGH Clinical Trial:

TNM Stage I Isn’t One Patient Population

AIM-HIGH Phase 3 Randomized Trial

Key Outcomes

RiskReveal vs. Blood-Based MRD Testing

What RiskReveal Gives You — and Your Patients

For high-risk patients:

For low-risk patients:

Workflow Integration: When and How to Order

Point 1: Pre-Operative Discussion

Point 2: First Post-Operative Visit

Ordering & Logistics

Sample Requirements

Turnaround Time

Order the Test

Insurance Coverage & Resources

Insurance & Patient Access

Questions about insurance or billing:

For Your Colleagues