SimplyTest Unveils Saliva-Based Oral HPV Test for Detecting High-Risk Strains

SimplyTest has announced the launch of a new saliva-based test designed to detect high-risk oral strains of human papillomavirus (HPV) associated with oropharyngeal cancers. 

The test, named the SimplyTest Oral HPV test, is positioned to be used in dental and functional­ medicine practices, with the goal of enabling earlier detection of HPV strains such as HPV-16, 18, 31, 33, 35, 39, 45 and others. HPV-16 alone accounts for the majority (often >85%) of HPV-positive oropharyngeal cancers.

The test is designed to be used in dental and functional medicine practices, offering a simple, accurate alternative to traditional screening methods, according to SimplyTest.

Unlike visual inspections or invasive swab-based methods, SimplyTest uses a simple, painless saliva sample paired with a high-complexity nucleic acid assay to detect clinically relevant HPV strains linked to oral and pharyngeal cancers. Results are typically available within 24 to 48 hours of lab receipt.

HPV, long recognized for its role in cervical cancer, is increasingly implicated in cancers of the oropharynx (the tonsils, base of tongue, back of throat). According to the CDC, about 10% of men and 3.6% of women in the US have an oral HPV infection; most clear within one to two years. 

HPV-related oropharyngeal cancers are on the rise, particularly among younger, non-smoking adults. Despite this, routine screening remains uncommon due to a lack of accessible, reliable tools. Most dental practices still rely on visual exams, which can miss infections in their early stages, says SimplyTest.

Related: Teal Wand Approved as First At-Home HPV Test for Cervical Cancer Screening

The SimplyTest Oral HPV test is offered as a laboratory-developed test (LDT) conducted under CLIA- and CAP-accredited standards. SimplyTest says the test adheres to the stringent validation requirements for high-complexity diagnostic assays and is processed exclusively within SimplyTest’s accredited laboratory facilities.

“As we continue to expand the SimplyTest platform, our mission remains clear: to make advanced diagnostic insights available at the very first point of care,” Damon Silvestry, CEO of SimplyTest, said. “The Oral HPV test delivers on that vision by empowering dental and functional medicine providers to detect high-risk HPV earlier, when timely intervention can make the greatest difference in patient outcomes.”

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The launch of the SimplyTest Oral HPV test complements other recent diagnostics in the HPV space. In May, the FDA granted clearance to Teal Wand, the first at-home self-collection device for cervical cancer screening. 

“The Oral HPV test was designed to make detection of high-risk HPV strains more accessible, more accurate and far less invasive,” said Dr. Joel Peek, chief innovation officer at SimplyTest. “By enabling dentists and other providers to screen for high-risk HPV with a simple saliva sample, we’re helping close a critical gap in cancer prevention.”

With more patients and providers showing interest in non-invasive diagnostics, the global market for HPV- and early-cancer screening technologies is projected to grow rapidly, providing a fertile foundation for integrative oral health platforms and preventive care models that converge dental, medical and consumer channels.