To evaluate the effectiveness of a rapid 4-gene mRNA test, qMIDSV3, as a triage tool for distinguishing oral squamous cell carcinoma from low-risk oral lesions.
Approach:
Study Design: Researchers analyzed 1,090 brush biopsy assays from 545 patients.
Test Evaluation: The qMIDSV3 assay distinguished oral squamous cell carcinoma from low-risk oral leukoplakia and oral lichen planus in less than 60 minutes.
Key Findings:
The assay achieved an AUC of 0.975.
Sensitivity was 95.7%, specificity was 95.1%, and overall accuracy was 95.5%.
Both false-positive and false-negative rates were kept under 5%.
The noninvasive brush can be repeated over time and requires no cold-chain storage.
It could spare over 90% of patients with low-risk oral lesions from unnecessary scalpel biopsies.
Interpretation:
The oral brush biopsy presents a promising noninvasive alternative for triaging oral lesions.
Conclusion:
The study suggests that the oral brush biopsy could be a valuable tool in identifying cancers needing attention while minimizing unnecessary procedures.
