Saliva Testing: A Promising Frontier in Disease Detection

Saliva testing holds promise for disease detection, offering an easier collection method than blood samples and containing substantial microbial information. Currently, saliva tests can detect viruses such as HIV and COVID-19, and assess genetic risks for breast cancer. Experts anticipate that within a few years, similar tests may diagnose conditions like diabetes or prostate cancer.

Experts anticipate that within a few years, similar tests may diagnose conditions like diabetes or prostate cancer.

Current Landscape: Adoption, Cost, and Regulatory Hurdles

Wallace Bellamy, president of the National Dental Association, indicated that routine salivary tests in dental care could facilitate earlier disease detection. However, widespread adoption is limited due to cost, with current tests ranging from $100 to $200 and often not covered by insurance. Samples are typically sent to specific labs for analysis.

Wallace Bellamy indicated that routine salivary tests in dental care could facilitate earlier disease detection.

Some tests, like those for cavities or oral cancer, exhibit high accuracy and are developed by labs approved by the Centers for Disease Control and Prevention (CDC). These tests, however, generally lack approval from the Food and Drug Administration (FDA), which mandates extensive reliability studies. OrisDX, for example, plans to launch a test for squamous cell head and neck cancers with a reported 93% reliability, with samples processed in a single lab.

Driving Future Adoption: Incentives and Challenges

To date, the only FDA-approved diagnostic saliva tests are for HIV and COVID-19. New financial incentives are emerging for companies to pursue FDA approval for various cancer detection tests. Recently, Congress mandated Medicare coverage for FDA-approved multicancer detection methods, including those using saliva. This is expected to encourage companies to invest in obtaining full FDA approval, as private insurers are likely to follow Medicare's lead in coverage.

To date, the only FDA-approved diagnostic saliva tests are for HIV and COVID-19.

One significant challenge in salivary testing is saliva's inherent variability. Factors such as brushing, eating, drinking, or smoking, and individual differences, can alter its composition. Researchers are working to identify specific salivary markers that can reliably indicate disease across diverse populations. Purnima Kumar, who chairs periodontics and oral health at the University of Michigan, noted that despite advancements, salivary tests should complement, rather than replace, in-person medical and dental care.

Purnima Kumar views salivary tests as a potential health alert system.