NeoGenomics, Inc. (NASDAQ: NEO) has received expanded Medicare coverage through the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program for use of its RaDaR ST assay in monitoring patients with late-stage solid tumors receiving immune-checkpoint inhibitors. The August 26 decision gives RaDaR ST its third Medicare-covered indication, alongside existing coverage in HPV-negative head and neck squamous-cell carcinoma and a subset of hormone receptor-positive, HER2-negative breast cancer. NeoGenomics says two additional RaDaR ST submissions remain pending with MolDX, making reimbursement expansion an increasingly important part of the assay’s commercial launch.
The new coverage is strategically different from conventional molecular residual-disease testing after curative surgery. These patients already have advanced cancer and are actively receiving systemic immunotherapy, meaning the clinical question is not simply whether microscopic disease remains after treatment but whether the malignancy is responding, stable or progressing while therapy continues. RaDaR ST uses a tumor-informed approach that can follow up to 48 patient-specific genomic variants identified through whole-exome sequencing and track the corresponding circulating tumor DNA longitudinally in plasma.
Why can immunotherapy be unusually difficult to monitor with imaging alone?
Checkpoint inhibitors can produce response patterns that differ from conventional cytotoxic chemotherapy. Immune-cell infiltration and treatment-associated inflammation can sometimes make lesions appear larger or create new radiographic abnormalities before subsequent scans clarify whether the cancer is truly progressing. This phenomenon, commonly described as pseudoprogression, can complicate decisions about continuing an effective treatment or abandoning one that is genuinely failing.
NeoGenomics is positioning serial ctDNA as a molecular layer that could help resolve some of that ambiguity. If patient-specific tumor variants fall sharply or become undetectable while an early scan looks concerning, the molecular information may support a different interpretation than if ctDNA is rising strongly at the same time. Conversely, increasing ctDNA could potentially reveal molecular progression before anatomical change becomes obvious on imaging.
The attraction becomes larger because immune-checkpoint therapy can continue for prolonged periods across lung, melanoma, bladder, renal and numerous other cancers. A blood test capable of clarifying response could influence not only treatment decisions but also the cost and toxicity associated with continuing expensive immunotherapy when disease has already escaped control.
How is RaDaR ST personalized to an individual tumor?
RaDaR ST is tumor informed rather than relying on the same universal panel for every patient. NeoGenomics performs whole-exome sequencing on tumor material, identifies variants specific to that individual malignancy and constructs a personalized set of up to 48 targets that can subsequently be sought in plasma.
The advantage is sensitivity. Instead of asking whether one predetermined mutation appears in circulation, the assay can look simultaneously for multiple molecular fingerprints known to belong to that patient’s tumor. NeoGenomics reports a 95% limit of detection around 11 parts per million and detection down to one part per million under particular study conditions, although the company correctly distinguishes those study-specific analytical figures from a universal guarantee for every specimen or clinical setting.
Tumor-informed testing also carries operational requirements. A usable tumor specimen must generally be available for initial sequencing, assay construction takes time and the molecular profile can evolve as metastatic disease accumulates new clones. Those trade-offs differ from tissue-free plasma assays that can be run without building a bespoke patient-specific panel.
Does Medicare coverage mean ctDNA can now replace CT scans during immunotherapy?
No, and this distinction is especially important after the reimbursement announcement. ASCO’s first broad clinical guideline on ctDNA testing, published in June 2026, states that ctDNA outside genetic-alteration testing may be offered when a specific evidence-based action can be taken from the result or when it can help resolve ambiguity in standard-of-care assessment. ASCO explicitly does not recommend ctDNA as a blanket replacement for existing standard-of-care testing.
For metastatic disease specifically, ASCO found substantial evidence that serial changes in ctDNA correlate with progression-free and overall outcomes, but the guideline concluded that evidence remains insufficient to establish routine clinical utility for changing therapy purely because ctDNA rises or falls. Stopping an otherwise effective checkpoint inhibitor too early or continuing ineffective treatment based on an incorrectly reassuring molecular result could both cause harm.
Medicare coverage and clinical-practice guidelines therefore answer different questions. MolDX has determined that RaDaR ST meets criteria for reimbursed use in this immunotherapy-monitoring context; that does not transform the blood test into a stand-alone treatment-switching algorithm or eliminate the need for imaging and clinical assessment.
Why could coverage still be commercially transformative for NeoGenomics?
Diagnostic adoption is frequently constrained less by scientific interest than by who pays for repeated testing. Treatment-response monitoring is inherently longitudinal, meaning the commercial opportunity is potentially larger than a one-time molecular test if patients undergo blood draws at multiple points during months or years of immunotherapy.
The new indication also takes RaDaR ST beyond relatively narrow post-surgical populations into advanced solid tumors receiving one of oncology’s most widely used therapeutic classes. NeoGenomics itself describes immunotherapy monitoring as a cornerstone of the RaDaR ST launch, while noting that two further MolDX submissions remain pending.
Coverage can additionally reduce the financial friction facing clinicians who want to incorporate ctDNA when scans are equivocal. A test may have strong published associations with treatment outcome but remain difficult to use routinely when patients face uncertain out-of-pocket costs.
The reimbursement decision consequently improves access before the field has settled every question about how clinicians should act on each molecular change. That sequencing is not unusual in rapidly evolving diagnostics but means evidence generation must continue alongside commercial rollout.
What clinical evidence would make ctDNA-guided immunotherapy monitoring much more powerful?
The strongest next step would be prospective randomized evidence showing that acting on ctDNA changes improves outcomes or reduces unnecessary treatment without compromising survival. For example, patients with rising molecular disease could be randomized to earlier treatment modification versus standard imaging-led management, or patients with sustained molecular clearance could be studied in carefully designed treatment-de-escalation strategies.
Those experiments are much harder than proving correlation. A test can predict which patients are likely to progress and still fail to improve outcomes if no effective action exists when the warning arrives.
This is the key distinction between clinical validity and clinical utility. RaDaR ST has evidence that ctDNA dynamics correlate with response and survival in several tumor contexts, and Medicare has now broadened access to that information. The remaining question is whether oncology can convert earlier molecular knowledge into better treatment decisions consistently enough to change the standard of care.
Why is this different from the broader MRD opportunity after surgery?
Postoperative MRD testing asks whether microscopic cancer remains after apparently curative treatment and whether recurrence risk is sufficiently high to justify adjuvant therapy or more intensive surveillance. Immunotherapy response monitoring asks a dynamic question during active metastatic treatment: is the disease actually being controlled right now?
Those are separate clinical markets with different evidence requirements. A test optimized for predicting recurrence after surgery cannot automatically be assumed to guide checkpoint-inhibitor decisions, even if the analytical technology is similar.
NeoGenomics is trying to build RaDaR ST across that entire disease continuum, listing recurrence-risk assessment, surveillance and systemic treatment-response monitoring as three core uses of the platform.
The new Medicare decision gives the company reimbursement support for the most dynamic of those applications. It also places greater responsibility on clinicians to interpret the information correctly. A personalized blood test can reveal molecular change long before a conventional scan settles the question, but earlier information is useful only when the next clinical action is at least as well understood as the test generating it.
