New brush test detects oral cancer in one hour
It could provide clinicians with a rapid, accurate and non-invasive way to triage patients
The use of a non-invasive brush biopsy test that can detect oral cancer within one hour has been outlined by a team of researchers in a paper published in the journal Biomarker Research.
The test could revolutionise oral cancer detection and prevent more than 90% of unnecessary and harmful scalpel biopsy procedures. These can be very painful, lead to infection and in some areas in the mouth such as the gum, it is hard to carry them out and may damage the underlying tooth/bone structure.
According to Global Burden of Disease data, lip and oral cancer is among the world’s most rapidly increasing causes of early death. More than 10,000 people in the UK were diagnosed with oral cancer last year, according to the charity Mouth Cancer, and 3,637 people lost their lives.
Worldwide, it affects 650,000 a year. Risk factors include tobacco use/smoking, alcohol, infection with the HPV virus and sun damage. More than half (53%) of all mouth cancers are diagnosed in stage IV, where the cancer is at its most advanced.
The study is the largest of its kind involving more than 1,000 samples from 545 patients. The team included researchers from Queen Mary University of London’s Centre for Oral Immunobiology & Regenerative Medicine, King George’s Medical University in India, Modern Dental College & Research Centre in India, and the All India Institute of Medical Sciences.
Early diagnosis of oral cancer – 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 scalpel oral biopsy can be extremely painful – especially in the tongue (the most common cancer site) – because part of the tongue is cut off, which discourages both patients and clinicians from doing this repeatedly and in a timely fashion.
The study aimed to find out if a successful microbiopsy-based multigene assay (qMIDS-V2) could be adapted into a rapid, non-invasive brush biopsy test (qMIDS-V3) for accurate OSCC detection. It found that this new test works, potentially sparing more than 90% of low-risk OPMD patients from unnecessary invasive tissue biopsies.
Muy-Teck Teh, Professor of Molecular Oral Oncology at Queen Mary, and the lead researcher said: “Oral cancer survival is directly linked to how early it is found, yet our current diagnostic pathway is blunt. Most patients with a suspicious lesion end up having an invasive biopsy even when the overwhelming likelihood is that it is benign.
“This test changes that. It gives clinicians a rapid, accurate and non-invasive way to triage patients, and crucially, it can be repeated. That means we can now monitor patients with persistent pre-malignant lesions regularly and systematically – and pick up cancers much earlier than we would have been able to before.”
In the UK, a 10 year audit reported a 450% rise in two week wait referrals alongside a 50% drop in cancer detection rate. Subsequent audits showed that 92.5–99.5% of referred patients were cancer free, with most (96-98%) remaining cancer free at the five-year follow up.
Those findings highlight substantial over referral and inefficiency in current pathways. Implementing a rapid, non invasive triage test such as qMIDS-V3 could reduce unnecessary referrals for more than 90% of cancer free patients and lessen the clinical and financial burden of managing OPMDs and OSCC.
In addition, qMIDS-V3 supports repeat brush biopsy, a critical capability for long-term surveillance, facilitating the detection of malignant transformation in OPMD patients while avoiding the need for multiple scalpel biopsies.
This latest study builds on a substantial body of prior clinical validation. The second-generation test, qMIDS-V2, was developed as a microbiopsy-based assay – a minimally invasive technique requiring only 1mm of tissue sample – and validated across more than 530 samples from three countries: the UK, India and China. That cross-continental validation established the robustness of the underlying multigene signature across diverse patient populations and clinical settings.
What makes the findings of this new study so striking is that qMIDS-V3 – which requires only a non-invasive brush swab of the mouth, with no tissue removal whatsoever – achieves test performance that is highly comparable to its microbiopsy predecessor.
“We were genuinely astonished by the fact that the brush swab test performance is comparable to a microbiopsy,” added Professor Teh.
“It suggests that the biological signal captured by these four genes is sufficiently strong and consistent that it can be detected even from the superficial exfoliated cells collected by a brush biopsy. The clinical implications are significant; patients no longer need even a minimally invasive procedure to benefit from molecularly guided triage.”
Beyond initial diagnosis, the test offers a further clinical benefit that has not previously been available at scale; because it is non-invasive and repeatable, it can be used to monitor patients with persistent OPMDs over time, conditions known to carry a risk of malignant transformation that is difficult to predict clinically.
Serial testing could significantly improve the chances of detecting early-stage cancers in this high-risk group, at a point when treatment is most likely to be successful and survival outcomes are best.
Queen Mary said it was actively looking for a commercial partner to help develop the inexpensive test for clinical use and that with the right partner, the test could be in use within two years.