Abstract / Summary
Background: Major breakthroughs in the clinical application of liquid biopsies, such as the use of salivary samples to detect biomarkers for the early detection of diseases and conditions, are on the horizon. Historically, late detection of oral cancer has contributed to high morbidity and mortality, making scientific advancements in this field particularly impactful. This guideline evaluates and provides recommendations for commercially available salivary adjunct tests in the United States designed specifically for screening adults without mucosal abnormalities and for determining the need for biopsy among adults with mucosal abnormalities of the oral cavity or lip.
Types of studies reviewed: The researchers used living systematic review methodology to identify evidence on the benefits and harms of salivary adjunct tests. They also conducted a scoping review of patient and clinician values and preferences regarding the use of these adjuncts and evaluated data on other contextual factors, including costs, equity, acceptability, and feasibility of these tests. The guideline panel formulated a recommendation after applying the Grading of Recommendations Assessment, Development and Evaluation Evidence to Decision framework.
Results: The panel issued 2 research-only recommendations, limiting the use of salivary adjunct tests for early oral cancer detection to research settings: 1 for adults with oral mucosal or lip abnormalities, and 1 for adults without mucosal abnormalities. Three good practice statements were also formulated: 2 recommending the performance of clinical oral examinations for all adult patients, and 1 recommending biopsy or referral for adult patients with persistent oral mucosal abnormalities.
Practical implications: All adult patients should receive a clinical oral examination. When a mucosal abnormality is identified, biopsy remains the reference standard for establishing a definitive diagnosis. Salivary diagnostic adjuncts, whether used to screen asymptomatic adults or to determine the need for biopsy in adults with mucosal abnormalities, should not be used in regular clinical practice or as a public health screening measure outside of a research setting. Further research is needed to establish the potential role of salivary adjunct tests in clinical practice.