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Background <p>Early diagnosis of oral squamous cell carcinoma (OSCC) is critical, yet most oral potentially malignant disorders (OPMDs) are benign, and patients frequently undergo unnecessary invasive scalpel biopsies, creating diagnostic delays and patient harm. A rapid, non-invasive molecular diagnostic tool could improve early detection and reduce unnecessary procedures. This study aims to determine whether a previously validated microbiopsy-based multigene assay (qMIDS<sup>V2</sup>) could be adapted into a rapid, non-invasive brush biopsy test (qMIDS<sup>V3</sup>) for accurate OSCC detection. A prespecified hypothesis was that qMIDS<sup>V3</sup> could distinguish OSCC from low-risk OPMD and contralateral normal mucosa with high diagnostic sensitivity.</p> Methods <p>This prospective diagnostic case-control study validated a multigene mRNA test (qMIDS<sup>V3</sup>) for OSCC detection using 1090 oral brush biopsies from 545 patients. Each patient provided paired brush biopsies from oral lesion and contralateral non-lesion mucosa, including OSCC (<i>n</i> = 443), oral leukoplakia (OL; <i>n</i> = 63), and oral lichen planus (OLP; <i>n</i> = 39). qPCR quantified mRNA levels of four genes (<i>INHBA</i>,<i> S100A16</i>,<i> YAP1</i>,<i> POLR2A</i>) from each brush biopsy, and an algorithm generated a malignancy index for cancer risk stratification.</p> Results <p>qMIDS<sup>V3</sup> distinguished OSCC from OL and OLP with AUC 0.975, sensitivity 95.7%, specificity 95.1%, and overall accuracy 95.5%. False-positive and false-negative rates were 4.9% and 4.3%, demonstrating high specificity for detecting malignant cells rather than premalignant or inflammatory lesions.</p> Conclusions <p>Our findings highlight the clinical utility of qMIDS<sup>V3</sup> as a rapid case-finding or triage test, potentially sparing over 90% of low-risk OPMD patients from unnecessary invasive tissue biopsies while accurately identifying OSCC cases. Non-invasive brush biopsy allows safe, repeatable sampling for long-term surveillance with minimal patient harm and enhancing early oral cancer detection. By reducing unnecessary scalpel biopsies and specialty referrals, qMIDS<sup>V3</sup> provides a molecularly guided and rapid triage pathway.</p>

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INHBA–S100A16 dysregulation enables a non-invasive molecular stratification platform for rapid detection of oral squamous cell carcinoma: results from a large diagnostic case-control study

  • 期刊论文

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  • 发表日期：

    2026年6月23日

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  • Muy-Teck Teh,
  • Ranjitkumar Patil,
  • Satyajit Ashok Tekade,
  • Deepika Mishra,
  • Akhilanand Chaurasia,
  • Ahmad Waseem

摘要

Background

Early diagnosis of oral squamous cell carcinoma (OSCC) is critical, yet most oral potentially malignant disorders (OPMDs) are benign, and patients frequently undergo unnecessary invasive scalpel biopsies, creating diagnostic delays and patient harm. A rapid, non-invasive molecular diagnostic tool could improve early detection and reduce unnecessary procedures. This study aims to determine whether a previously validated microbiopsy-based multigene assay (qMIDSV2) could be adapted into a rapid, non-invasive brush biopsy test (qMIDSV3) for accurate OSCC detection. A prespecified hypothesis was that qMIDSV3 could distinguish OSCC from low-risk OPMD and contralateral normal mucosa with high diagnostic sensitivity.

Methods

This prospective diagnostic case-control study validated a multigene mRNA test (qMIDSV3) for OSCC detection using 1090 oral brush biopsies from 545 patients. Each patient provided paired brush biopsies from oral lesion and contralateral non-lesion mucosa, including OSCC (n = 443), oral leukoplakia (OL; n = 63), and oral lichen planus (OLP; n = 39). qPCR quantified mRNA levels of four genes (INHBA, S100A16, YAP1, POLR2A) from each brush biopsy, and an algorithm generated a malignancy index for cancer risk stratification.

Results

qMIDSV3 distinguished OSCC from OL and OLP with AUC 0.975, sensitivity 95.7%, specificity 95.1%, and overall accuracy 95.5%. False-positive and false-negative rates were 4.9% and 4.3%, demonstrating high specificity for detecting malignant cells rather than premalignant or inflammatory lesions.

Conclusions

Our findings highlight the clinical utility of qMIDSV3 as a rapid case-finding or triage test, potentially sparing over 90% of low-risk OPMD patients from unnecessary invasive tissue biopsies while accurately identifying OSCC cases. Non-invasive brush biopsy allows safe, repeatable sampling for long-term surveillance with minimal patient harm and enhancing early oral cancer detection. By reducing unnecessary scalpel biopsies and specialty referrals, qMIDSV3 provides a molecularly guided and rapid triage pathway.