A few weeks ago, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.
Individuals can order the test — CancerDetect Test for Oral & Throat Cancer — directly from its maker, Viome Life Sciences, for $399.
It is not covered by medical insurance and is not approved by the US Food and Drug Administration. The test is being marketed under the agency's "laboratory-developed test" rubric.
People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer.
During a 15-minute telemedicine conference — included in the $399 cost — those who test positive are told to follow up with a secondary care center for a definitive diagnosis.
For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guru Banavar, Ph.D., is Viome's chief technology officer.
Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.
CancerDetect's tagline is "test at home for peace of mind." The test "brings unprecedented accuracy to early cancer detection and prevention," the company said in a press release announcing the launch.
The test showed an overall specificity of 94% and sensitivity of 84.2% to 90% for cancer in Viome's latest study, which is posted on medRxiv.org as a preprint.
Banavar said it has been submitted to a top-tier medical journal.