National Advertising Division Finds Certain CancerDetect® Claims Supported; Recommends Viome Modify or Discontinue Others
New York, NY – March 24, 2026 – In a challenge brought by BBB National Programs’ National Advertising Division, Viome Life Sciences, Inc. was found to have a reasonable basis for certain claims regarding its ability to detect biomarkers associated with early-stage oral and throat cancer. However, the National Advertising Division (NAD) recommended Viome modify or discontinue other claims related to comparative sensitivity and messages conveyed about cancer diagnosis.
Viome is a biotech company that develops various health tests, including the CancerDetect® Oral & Throat at Home Test (CDOT). At issue for NAD were ads on Viome’s website promoting the CDOT Test, including claims about biomarker detection, comparative accuracy, and whether the ads conveyed that the test ensures early diagnosis of oral and throat cancer.
NAD further recommended that Viome clearly and conspicuously disclose in its advertising the limitations of the study upon which it relied to support the challenged claim concerning the detection of biomarkers associated with early-stage oral and throat cancer.
NAD determined that the claim “Eligible individuals can now test with the confidence of high accuracy to detect biomarkers associated with oral and/or throat cancer” was supported.
During the proceeding, Viome modified its “Substantially higher accuracy over current screening methods” claim. For compliance purposes, this voluntarily modified claim will be treated as though NAD recommended its modification and Viome agreed to comply.
In its advertiser statement, Viome said it “will comply with NAD’s decision.”
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. This press release shall not be used for advertising or promotional purposes.
Viome is a biotech company that develops various health tests, including the CancerDetect® Oral & Throat at Home Test (CDOT). At issue for NAD were ads on Viome’s website promoting the CDOT Test, including claims about biomarker detection, comparative accuracy, and whether the ads conveyed that the test ensures early diagnosis of oral and throat cancer.
Detection of Biomarkers
In the context in which they appear, NAD determined the challenged claims communicate a strong message to consumers at risk of oral and throat cancer that the CDOT Test will ensure early diagnosis of oral and throat cancer through a detection of biomarkers associated with early-stage oral & throat cancers. Lay consumers may not distinguish between the detection of a biomarker and detection of cancer, so NAD recommended that Viome make clear, in close proximity to any claim regarding detection of biomarkers, that the CDOT Test does not itself diagnose early-stage oral or throat cancer.NAD further recommended that Viome clearly and conspicuously disclose in its advertising the limitations of the study upon which it relied to support the challenged claim concerning the detection of biomarkers associated with early-stage oral and throat cancer.
“First At Home Test” and Related Claims
As the record did not identify any other commercially available at-home tests designed to detect biomarkers associated with early-stage oral and throat cancer, NAD determined that the claim “CancerDetect Oral & Throat is the first at-home test of its kind to detect biomarkers associated with early-stage oral and throat cancer” was supported. NAD also found that Viome’s reference to the test as “revolutionary,” “simple-to-use,” the duration of sample collection (“a few minutes”), and the inclusion of healthcare provider guidance were supported.Comparative Sensitivity and Specificity Claims
NAD examined the claim that the CDOT Test has “substantially higher sensitivity and specificity over conventional oral exam.” NAD found the evidence provided in support of the claim had significant limitations and, therefore, limited applicability in quantifying the performance of conventional oral exams. Consequently, NAD recommended that Viome discontinue the claim but noted that it could make a monadic claim concerning the high sensitivity and specificity of its test to detect early-stage oral and throat cancer biomarkers.NAD determined that the claim “Eligible individuals can now test with the confidence of high accuracy to detect biomarkers associated with oral and/or throat cancer” was supported.
During the proceeding, Viome modified its “Substantially higher accuracy over current screening methods” claim. For compliance purposes, this voluntarily modified claim will be treated as though NAD recommended its modification and Viome agreed to comply.
In its advertiser statement, Viome said it “will comply with NAD’s decision.”
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. This press release shall not be used for advertising or promotional purposes.