Evaluating Diagnostic Accuracy and Cost Implications in MASLD Fibrosis Staging

As noninvasive tests (NITs) continue to replace liver biopsy in MASLD clinical practice and trials, the performance characteristics of different modalities remain under active evaluation. A recent analysis compared Magnetic Resonance Elastography (MRE) and Vibration-Controlled Transient Elastography (VCTE) in identifying F2–F3 fibrosis—patients who may be eligible for pharmacologic intervention.

Study Overview: MRE vs VCTE

In a cohort of 103 MASLD patients:

• MRE identified 18 patients with F2–F3 fibrosis.

• VCTE identified 33 patients as F2–F3.

While VCTE identified more patients as treatment-eligible, further inspection revealed that 15 of the 33 VCTE-classified F2–F3 cases were not supported by MRE or by expected disease prevalence.

This suggests a false-positive rate of approximately 45% for VCTE in this cohort—consistent with prior literature showing VCTE’s tendency to overstage fibrosis, particularly in patients with elevated BMI or hepatic inflammation.

Projecting to Larger Populations

Assuming these findings generalize, what would this look like in a screening cohort of 1,000 patients?

	MRE	VCTE
Patients flagged F2–F3	175	320
Estimated true positives	175	175
Estimated false positives	~0	~145
Annual treatment cost at $47,400	$8.3M	$15.2M

The difference in total cost—$6.9 million annually—is attributable to false-positive patients receiving treatment under the VCTE pathway.

Technical Considerations

• VCTE is known to have technical failure rates as high as 15–20% in patients with obesity.

• Many trials and clinics require 2–3 VCTE scans per patient to ensure an interpretable result.

• MRE, by contrast, has a technical success rate >98%, and evaluates the liver in its entirety.

Importantly, MRE’s repeatability coefficient (~10%) allows for greater confidence in monitoring change over time, compared to repeatability coefficients of 50–70% reported for VCTE in some populations.

Implications for Clinical Trials and Payer Strategy

• From a clinical trial perspective, over-inclusion due to VCTE overstaging may dilute treatment effects and increase sample size requirements.

• From a payer standpoint, initiating expensive therapies in false-positive patients has direct cost implications, particularly when NITs are used as gatekeeping tools for drug eligibility.

Conclusion

As noninvasive fibrosis staging tools are increasingly relied upon in MASLD, test specificity and reproducibility become critical—not only for individual patient care, but for trial design, payer policy, and system-level efficiency.

More studies will be needed to validate optimal cutoff strategies across populations, but these findings highlight the importance of understanding not just who gets flagged—but whether those patients actually have the disease in question.