The First and Only Tests to Identify a Tumor-Initiating and Stem Cell-Associated Biomarker for Oral Cancer

The OncAlert® Oral Cancer RAPID Test and the OncAlert Oral Cancer LAB Test are technologically advanced and highly accurate methods to aid in the early detection of oral cancer (including oral and oropharyngeal cancer) through the unprecedented detection of CD44 and total protein levels collected in an oral rinse.

CD44 is significantly overexpressed in oral cancer even in early stages.

The qualitative biomarker assay (OncAlert RAPID), with a negative predictive value (NPV) of 92%†, performs well in ruling out oral cancer when a reasonable suspicion exists.

OncAlert: Improving the Standard of Care

Examination Type Sensitivity Specificity
Conventional 64 31-76
OncAlert RAPID 79-95* 53-70*
OncAlert LAB 80** 93**

† With 95% CI of 84% – 96%

* Sensitivity or Specificity is dependent upon selected biomarker threshold.

** Without clinical variables, the OncAlert LAB Test will yield a false negative rate of 15% while the false positive rate is 52%. The biomarker assay performs well in confirming when there is a reasonable suspicion of cancer, but will not effectively assist in the discrimination of more benign processes.

OncAlert LAB, when used together with a quantitative algorithm that incorporates clinical variables with biomarker levels, provides better discrimination of cancer vs. benign processes.